MOBILITY OE: Trial to Evaluate the Safety & Efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01396525
• Collaborator: (none)
• Enrollment: 153
• Location: 1
• Arm: 1
• Duration (Months): 63
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Vascular Disease	Device: Omnilink Elite™ Peripheral Balloon-Expandable Stent System	Phase 3

Detailed Description

The MOBILITY study was a prospective, non-randomized, two-arm, multi-center study. The 2 arms (Omnilink Elite arm and Absolute Pro arm) were designed to independently assess the safety and effectiveness of the 2 devices used in this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Non-randomized, Two Arm, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System and the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omnilink Elite™ Peripheral Balloon-Expandable Stent System	Device: Omnilink Elite™ Peripheral Balloon-Expandable Stent System; Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).

Outcome Measures

Primary Outcome Measures

1. Major Adverse Event (MAE) [9 months]

   Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).

Secondary Outcome Measures

1. Device Success [Acute: from beginning of index procedure to end of procedure]

   On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).

2. Technical Success [Acute: from beginning of index procedure to end of procedure]

   Technical success is defined as device success (the achievement of successful delivery and deployment of the trial device(s) at the intended target lesion(s), successful withdrawal of the delivery catheter(s)), and attainment of a final residual stenosis of < 30% by QA or as reported by the investigator.

3. Procedure Success [Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner]

   Procedure success is defined as technical success (device success and attainment of a final residual stenosis of < 30% by QA) without complications within two (2) days after the index procedure or at hospital discharge, whichever is sooner.

4. Thigh Brachial Index (TBI) for the Treated Limb(s) [Pre-procedure]

   The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

5. Thigh Brachial Index (TBI) for the Treated Limb(s) [Post-Procedure]

   The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

6. Thigh Brachial Index (TBI) for the Treated Limb(s) [1 month]

   The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

7. Thigh Brachial Index (TBI) for the Treated Limb(s) [9 months]

   The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

8. Thigh Brachial Index (TBI) for the Treated Limb(s) [2 years]

   The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

9. Thigh Brachial Index (TBI) for the Treated Limb(s) [3 years]

   The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

10. Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) [Between baseline and Post-procedure]

    The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.

11. Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) [Between Baseline and 1 month]

    The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.

12. Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) [Between baseline and 9 months]

    The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.

13. Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) [Between baseline and 2 years]

    The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.

14. Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) [Between baseline and 3 years]

    The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.

15. Walking Impairment Questionaire Scores [Pre-procedure]

    Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

16. Walking Impairment Questionaire Scores [1 month]

    Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

17. Walking Impairment Questionaire Scores [9 months]

    Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

18. Walking Impairment Questionaire Scores [2 years]

    Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

19. Walking Impairment Questionaire Scores [3 years]

    Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

20. Rutherford Becker Clinical Category for the Treated Limb(s) [Pre-Procedure]

    The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

21. Rutherford Becker Clinical Category for the Treated Limb(s) [1 month]

    The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

22. Rutherford Becker Clinical Category for the Treated Limb(s) [9 months]

    The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

23. Rutherford Becker Clinical Category for the Treated Limb(s) [2 years]

    The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

24. Rutherford Becker Clinical Category for the Treated Limb(s) [3 years]

    The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

25. Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) [Between baseline and 1 month]

    Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.

26. Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) [Between baseline and 9 months]

    Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.

27. Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) [Baseline and 2 years]

    Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.

28. Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) [Baseline and 3 years]

    Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.

29. Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) [1 month and 9 months]

    Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years.Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by Duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).

30. Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) [18 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).

31. Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) [2 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).

32. Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) [3 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).

33. Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) [1 month and 9 months]

    Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).

34. Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) [18 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).

35. Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) [2 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).

36. Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) [3 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).

37. Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) [1 month and 9 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).

38. Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) [18 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).

39. Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) [2 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).

40. Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) [3 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).

41. Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) [1 month and 9 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).

42. Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (TVR) for the Treated Limb(s) [18 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography)

43. Kaplan-Meier Estimate of Freedom From Clinically Driven Target Vessel Revascularization (TVR) for the Treated Limb(s) [2 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).

44. Kaplan-Meier Estimate of Freedom From Clinically DrivenTarget Vessel Revascularization (TVR) for the Treated Limb(s) [3 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).

45. Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) [1 month and 9 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).

46. Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) [18 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).

47. Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) [2 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).

48. Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) [3 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).

49. Primary Stent Patency [1 month]

    Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.

50. Primary Stent Patency [9 months]

    Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.

51. Primary Stent Patency [2 years]

    Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure

52. Primary Stent Patency [3 years]

    Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure

53. Restenosis [9 months]

    Defined as ≥ 50% stenosis at follow-up.

54. Restenosis [2 years]

    Defined as ≥ 50% stenosis at follow-up.

55. Restenosis [3 years]

    Defined as ≥ 50% stenosis at follow-up.

56. Kaplan-Meier Estimate of Freedom From Death (All Cause) [1 month and 9 months]

    Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years

57. Kaplan-Meier Estimate of Freedom From Death (All Cause) [18 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.

58. Kaplan-Meier Estimate of Freedom From Death (All Cause) [2 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.

59. Kaplan-Meier Estimate of Freedom From Death (All Cause) [3 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.

60. Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) [1 month and 9 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.

61. Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) [18 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.

62. Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) [2 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.

63. Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) [3 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.

64. Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) [1 month and 9 months]

    Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.

65. Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) [18 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.

66. Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) [2 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.

67. Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) [3 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.

68. Kaplan-Meier Estimate of Freedom From Embolic Events [1 month and 9 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.

69. Kaplan-Meier Estimate of Freedom From Embolic Events [18 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.

70. Kaplan-Meier Estimate of Freedom From Embolic Events [2 years]

    Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.

71. Kaplan-Meier Estimate of Freedom From Embolic Events [3 years]

    Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.

72. Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s) [1 month and 9 months]

    Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.

73. Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s) [18 months]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.

74. Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s) [2 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.

75. Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s) [3 years]

    Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.

76. Stent Thrombosis [1 month]

    Defined as a total occlusion documented by duplex ultrasound and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.

77. Changes in Quality of Life Measures: Physical Component Summary [Baseline and 1 month]

    This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

78. Changes in Quality of Life Measures: Physical Component Summary [Baseline and 9 months]

    This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

79. Changes in Quality of Life Measures: Physical Component Summary [Baseline and 2 years]

    This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

80. Changes in Quality of Life Measures: Physical Component Summary [Baseline and 3 years]

    This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

81. Changes in Quality of Life Measures: Mental Component Summary [Baseline and 1 month]

    This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

82. Changes in Quality of Life Measures: Mental Component Summary [Baseline and 9 months]

    This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

83. Changes in Quality of Life Measures: Mental Component Summary [Baseline and 2 years]

    This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

84. Changes in Quality of Life Measures: Mental Component Summary [Baseline and 3 years]

    This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Clinical Inclusion Criteria:

1. Subject must be at least 18 and < 90 years of age.

2. Subject has been informed of the nature of the trial, agrees to its provisions, and has signed the informed consent form.

3. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.

4. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4).

5. Female subjects of childbearing potential must have had a negative pregnancy test before treatment, and must not be nursing at the time of treatment, and agree at time of consent to use birth control during participation in this trial up to and including the follow-up at 9 months.

Angiographic Inclusion Criteria

1. Up to two bilateral de novo or restenotic lesions of the native common iliac artery and/or native external iliac artery may be treated(one per side).

2. Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis (total occlusion)

3. External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis

4. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 110 mm (Absolute Pro)

5. Lesion length for total occlusion of the common iliac artery visually estimated to be ≤40 mm

6. Target vessel reference diameter visually estimated to be ≥3.6 mm and ≤9.1 mm (Absolute Pro)

7. On the treatment side(s), patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis.

8. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 50 mm (Omnilink Elite).

9. Target vessel reference diameter visually estimated to be ≥ 5.0 mm and ≤ 11.0 mm (Omnilink Elite).

Clinical Exclusion Criteria

1. Subject is unable to walk.

2. Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary artery bypass graft surgery, thoracic surgery.

3. Subject has received, or is on the waiting list for a major organ transplant (heart, lung, kidney, liver).

4. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6.

5. Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s).

6. Subject has elevated serum creatinine > 2.0 mg/dl.

7. Subject has uncontrolled diabetes mellitus (DM) (serum glucose > 400 mg/dl).

8. Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30 days.

9. Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subjects ability to walk.

10. Subject has unstable angina defined as rest angina with ECG changes.

11. Subject has a groin infection, or an acute systemic infection that is currently under treatment.

12. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.

13. Subject requires any planned procedure within 30 days after the index procedure that would necessitate the discontinuation of aspirin, clopidogrel or ticlopidine following the procedure.

14. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with limited life-expectancy (i.e., less than 2 years).

15. Subject is currently participating in an investigational drug or device trial that has not completed the primary endpoint follow-up or that clinically interferes with the current trial endpoints.

16. Subject is unable to understand or unwilling to cooperate with trial procedures or is unwilling or unable to return to the treatment center for follow-up visits.

17. If intended stent is Absolute Pro, subject has known hypersensitivity or contraindication to nickel, titanium or platinum; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.

18. Subject has known allergy or contraindication to aspirin or clopidogrel (Plavix®); if allergy or contraindication is to clopidogrel, subject is unable to tolerate ticlopidine (Ticlid®).

19. Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions.

20. Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy.

21. If intended stent is Omnilink Elite, subject has known hypersensitivity or contraindication to cobalt chromium; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.

22. Requirement of general anesthesia or spinal block for the procedure.

23. Presence of contralateral limb amputation that was performed to treat any non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic.

24. Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior tibial, posterior tibial, peroneal, ipsilateral to the target lesion.

25. Subject requires a concomitant percutaneous endovascular procedure in another vessel, e.g. coronary.

26. Target lesion is in an iliac artery that has been previously stented.

Angiographic Exclusion Criteria

1. Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to the target lesion.

2. Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the target lesion

3. Target lesion is within or adjacent to an aneurysm.

4. Lesion is located within or beyond a vessel that contains a bypass graft.

5. Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery.

6. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm

3cm.

1. Lesion extends beyond the inguinal ligament.

2. Subject has angiographic evidence of thrombus in the target disease segment or vessel that is unresponsive to anti-thrombotic therapies.

3. Subject has multilevel disease in the target extremity that requires other staged procedures within 30 days before or after the procedure.

4. On the treatment side(s), subject is without patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis.

5. Requirement for > 1 stent to treat full length of lesion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abbott Vascular	Santa Clara	California	United States	95054

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Tony S. Das, MD, Presbyterian Heart Institute, Dallas, TX
• Principal Investigator: Manish Mehta, MD, MPH, Albany Medical Center, Albany, NY.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01396525
• Other Study ID Numbers: 08-107 Omnilink Elite Arm (OE); 08-107 AP, NCT00844532
• First Posted: Jul 18, 2011
• Last Update Posted: Feb 8, 2016
• Last Verified: Dec 1, 2015

• Keywords provided by Abbott Medical Devices: Atherosclerosis; Peripheral artery disease; Peripheral vascular disease; PAD; Claudication; Peripheral Arterial Occlusive Disease; Stent; PAOD; PVD
• Additional relevant MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease

Study Results

Participant Flow

Recruitment Details	Subjects with chronic lower extremity peripheral arterial disease (PAD) admitted for percutaneous CIA or EIA revascularization were screened for eligibility. Subjects who met all general and clinical eligibility criteria, and signed the informed consent, underwent arteriography of the target iliac artery.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Period Title: Overall Study
STARTED	153
COMPLETED	127
NOT COMPLETED	26

Baseline Characteristics

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Overall Participants	153
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	87 56.9%
>=65 years	66 43.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.9 (9.0)
Sex: Female, Male (Count of Participants)
Female	65 42.5%
Male	88 57.5%
Region of Enrollment (participants) [Number]
United States	153 100%

Outcome Measures

1. Primary Outcome

Title	Major Adverse Event (MAE)
Description	Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	149
Number (95% Confidence Interval) [percentage of participants]	5.4 3.5%

2. Secondary Outcome

Title	Device Success
Description	On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).
Time Frame	Acute: from beginning of index procedure to end of procedure

Outcome Measure Data

Analysis Population Description

ITT population, per device analysis. Included 210 stents plus 1 stent inserted but not implanted due to device malfunction, 2 stents excluded due to inappropriate sizing (stents were not implanted), 1 stent excluded as stent was not implanted per physician's choice and had no device malfunction.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure devices	211
Number (95% Confidence Interval) [percentage of devices]	98.6

3. Secondary Outcome

Title	Technical Success
Description	Technical success is defined as device success (the achievement of successful delivery and deployment of the trial device(s) at the intended target lesion(s), successful withdrawal of the delivery catheter(s)), and attainment of a final residual stenosis of < 30% by QA or as reported by the investigator.
Time Frame	Acute: from beginning of index procedure to end of procedure

Outcome Measure Data

Analysis Population Description

ITT population, per lesion analysis

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure target lesions	203
Number (95% Confidence Interval) [percentage of target lesions]	93.1

4. Secondary Outcome

Title	Procedure Success
Description	Procedure success is defined as technical success (device success and attainment of a final residual stenosis of < 30% by QA) without complications within two (2) days after the index procedure or at hospital discharge, whichever is sooner.
Time Frame	Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Number (95% Confidence Interval) [percentage of participants]	91.5 59.8%

5. Secondary Outcome

Title	Thigh Brachial Index (TBI) for the Treated Limb(s)
Description	The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time Frame	Pre-procedure

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	141
Measure Limbs	189
Mean (Standard Deviation) [Ratio]	0.9 (0.2)

6. Secondary Outcome

Title	Thigh Brachial Index (TBI) for the Treated Limb(s)
Description	The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time Frame	Post-Procedure

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	141
Measure Limbs	188
Mean (Standard Deviation) [Ratio]	1.0 (0.2)

7. Secondary Outcome

Title	Thigh Brachial Index (TBI) for the Treated Limb(s)
Description	The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	133
Measure Limbs	178
Mean (Standard Deviation) [Ratio]	1.0 (0.1)

8. Secondary Outcome

Title	Thigh Brachial Index (TBI) for the Treated Limb(s)
Description	The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	136
Measure Limbs	180
Mean (Standard Deviation) [Ratio]	1.0 (0.2)

9. Secondary Outcome

Title	Thigh Brachial Index (TBI) for the Treated Limb(s)
Description	The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	106
Measure Limbs	140
Mean (Standard Deviation) [Ratio]	1.0 (0.1)

10. Secondary Outcome

Title	Thigh Brachial Index (TBI) for the Treated Limb(s)
Description	The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	96
Measure Limbs	132
Mean (Standard Deviation) [Ratio]	1.0 (0.2)

11. Secondary Outcome

Title	Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
Description	The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.
Time Frame	Between baseline and Post-procedure

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	133
Measure Limbs	179
Mean (Standard Deviation) [Ratio]	0.2 (0.2)

12. Secondary Outcome

Title	Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
Description	The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.
Time Frame	Between Baseline and 1 month

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	125
Measure Limbs	168
Mean (Standard Deviation) [Ratio]	0.2 (0.2)

13. Secondary Outcome

Title	Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
Description	The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.
Time Frame	Between baseline and 9 months

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	124
Measure Limbs	166
Mean (Standard Deviation) [Ratio]	0.1 (0.2)

14. Secondary Outcome

Title	Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
Description	The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Time Frame	Between baseline and 2 years

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	96
Measure Limbs	128
Mean (Standard Deviation) [Ratio]	0.2 (0.2)

15. Secondary Outcome

Title	Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
Description	The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Time Frame	Between baseline and 3 years

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	87
Measure Limbs	122
Mean (Standard Deviation) [Ratio]	0.2 (0.2)

16. Secondary Outcome

Title	Walking Impairment Questionaire Scores
Description	Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time Frame	Pre-procedure

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis

Arm/Group Title	Walking Distance Score	Walking Speed Score	Stair Climbing Score
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	152	151	151
Mean (Standard Deviation) [score on a scale]	17.5 (22.7)	20.1 (24.0)	26.0 (25.8)

17. Secondary Outcome

Title	Walking Impairment Questionaire Scores
Description	Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Walking Distance Score	Walking Speed Score	Stair Climbing Score
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	131	131	129
Mean (Standard Deviation) [score on a scale]	56.4 (38.0)	50.4 (34.4)	56.1 (36.7)

18. Secondary Outcome

Title	Walking Impairment Questionaire Scores
Description	Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Walking Distance Score	Walking Speed Score	Stair Climbing Score
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	138	138	134
Mean (Standard Deviation) [score on a scale]	56.6 (38.6)	47.6 (33.2)	60.4 (35.9)

19. Secondary Outcome

Title	Walking Impairment Questionaire Scores
Description	Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Walking Distance Score	Walking Speed Score	Stair Climbing Score
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	112	113	112
Mean (Standard Deviation) [score on a scale]	49.1 (37.9)	44.5 (31.1)	51.7 (33.8)

20. Secondary Outcome

Title	Walking Impairment Questionaire Scores
Description	Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Walking Distance Score	Walking Speed Score	Stair Climbing Score
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	107	107	105
Mean (Standard Deviation) [score on a scale]	46.8 (37.1)	41.8 (30.4)	55.4 (34.9)

21. Secondary Outcome

Title	Rutherford Becker Clinical Category for the Treated Limb(s)
Description	The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time Frame	Pre-Procedure

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure limb(s)	203
0	0.0
1	0.0
2	43.8
3	54.7
4	1.5
5	0.0
6	0.0

22. Secondary Outcome

Title	Rutherford Becker Clinical Category for the Treated Limb(s)
Description	The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	134
Measure limbs	180
0	57.8
1	23.9
2	15.0
3	3.3
4	0.0
5	0.0
6	0.0

23. Secondary Outcome

Title	Rutherford Becker Clinical Category for the Treated Limb(s)
Description	The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	137
Measure limbs	182
0	59.9
1	23.6
2	11.5
3	4.4
4	0.5
5	0.0
6	0.0

24. Secondary Outcome

Title	Rutherford Becker Clinical Category for the Treated Limb(s)
Description	The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	108
Measure limbs	143
0	66.0
1	16.0
2	15.3
3	2.8
4	0.0
5	0.0
6	0.0

25. Secondary Outcome

Title	Rutherford Becker Clinical Category for the Treated Limb(s)
Description	The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	101
Measure limbs	138
0	64.0
1	16.5
2	15.1
3	3.6
4	0.0
5	0.0
6	0.7

26. Secondary Outcome

Title	Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Description	Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time Frame	Between baseline and 1 month

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	134
Measure Limbs	180
Improved by >/= 3 categories	36.1
Improved by 2 categories	34.4
Improved by 1 category	18.9
No change	8.9
Worsened by 1 category	1.7
Worsened by 2 categories	0.0
Worsened by 3 categories or more	0.0

27. Secondary Outcome

Title	Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Description	Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time Frame	Between baseline and 9 months

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	137
Measure Limbs	182
Improved by >/= 3 categories	34.6
Improved by 2 categories	41.2
Improved by 1 category	13.2
No change	7.1
Worsened by 1 category	3.8
Worsened by 2 categories	0.0
Worsened by 3 categories or more	0.0

28. Secondary Outcome

Title	Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Description	Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	108
Measure Limbs	143
Improved by >/= 3 categories	35.4
Improved by 2 categories	37.5
Improved by 1 category	16.7
No change	9.0
Worsened by 1 category	1.4
Worsened by 2 categories	0.0
Worsened by >/= 3 categories	0.0

29. Secondary Outcome

Title	Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Description	Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time Frame	Baseline and 3 years

Outcome Measure Data

Analysis Population Description

ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	101
Measure Limbs	138
Improved by >/= 3 categories	38.8
Improved by 2 categories	33.1
Improved by 1 category	15.1
No Change	11.5
Worsened by 1 category	0.7
Worsened by 2 categories	0.0
Worsened by >/= 3 categories	0.7

30. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Description	Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years.Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by Duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time Frame	1 month and 9 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
1 month	99.0
9 months	95.5

31. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with target lesions who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
Number [percentage of target lesions]	93.9

32. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with target lesions who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
Number [percentage of target lesions]	90.5

33. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with target lesions who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
Number [percentage of target lesions]	87.6

34. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Description	Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).
Time Frame	1 month and 9 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
1 month	99.5
9 months	97

35. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with target lesions who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
Number [percentage of target lesions]	95.3

36. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with target lesions who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
Number [percentage of target lesions]	93.1

37. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with target lesions who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
Number [percentage of target lesions]	90.8

38. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).
Time Frame	1 month and 9 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure lesions	203
1 month	99.0
9 months	98.5

39. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
Number [percentage of target vessels]	98.0

40. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
Number [percentage of target vessels]	97.4

41. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
Number [percentage of target vessels]	95.6

42. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Time Frame	1 month and 9 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure lesions	203
1 month	99.5
9 months	99.5

43. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (TVR) for the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography)
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
Number [percentage of target vessels]	99

44. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Clinically Driven Target Vessel Revascularization (TVR) for the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
Number [percentage of target vessels]	98.4

45. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Clinically DrivenTarget Vessel Revascularization (TVR) for the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure Lesions	203
Number [percentage of target vessels]	96.6

46. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time Frame	1 month and 9 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure limbs	203
1 month	99.5
9 months	98.0

47. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure limbs	203
Number [percentage of limbs]	95.8

48. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure limbs	203
Number [percentage of limbs]	94.1

49. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure limbs	203
Number [percentage of limbs]	94.1

50. Secondary Outcome

Title	Primary Stent Patency
Description	Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	141
Measure limbs	188
Number [percentage of limbs]	97.3

51. Secondary Outcome

Title	Primary Stent Patency
Description	Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	137
Measure limbs	179
Number [percentage of limbs]	89.9

52. Secondary Outcome

Title	Primary Stent Patency
Description	Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	123
Measure limbs	163
Number [percentage of limbs]	76.7

53. Secondary Outcome

Title	Primary Stent Patency
Description	Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	118
Measure Limbs	155
Number [percentage of limbs]	68.4

54. Secondary Outcome

Title	Restenosis
Description	Defined as ≥ 50% stenosis at follow-up.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	137
Measure limbs	185
Number (95% Confidence Interval) [percentage of limbs]	9.7

55. Secondary Outcome

Title	Restenosis
Description	Defined as ≥ 50% stenosis at follow-up.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	121
Measure limbs	159
Number (95% Confidence Interval) [percentage of limbs]	20.8

56. Secondary Outcome

Title	Restenosis
Description	Defined as ≥ 50% stenosis at follow-up.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	113
Measure limbs	148
Number (95% Confidence Interval) [percentage of limbs]	27.0

57. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Death (All Cause)
Description	Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years
Time Frame	1 month and 9 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects who were event free at this timepoint.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
1 month	100 65.4%
9 months	99.3 64.9%

58. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Death (All Cause)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Number [percentage of participants]	94.5 61.8%

59. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Death (All Cause)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Number [percentage of participants]	93.8 61.3%

60. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Death (All Cause)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Number [percentage of participants]	90.2 59%

61. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time Frame	1 month and 9 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects who were event free at this timepoint

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
1 month	100.0 65.4%
9 months	99.3 64.9%

62. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

ITT population. This analysis represents those subjects who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Number [percentage of participants]	97.2 63.5%

63. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Number [percentage of participants]	95.7 62.5%

64. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Number [percentage of participants]	95.7 62.5%

65. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Description	Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.
Time Frame	1 month and 9 months

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure limbs	203
1 month	100.0
9 months	100.0

66. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure limbs	203
Number [percentage of target limbs]	100

67. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure limbs	203
Number [percentage of target limbs]	100

68. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure limbs	203
Number [percentage of target limbs]	99.4

69. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Embolic Events
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Time Frame	1 month and 9 months

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects who were event free at this timepoint

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
1 month	99.3
9 months	98.0

70. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Embolic Events
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects who were event free at this timepoint

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Number [percentage of particpants]	98

71. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Embolic Events
Description	Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Number [percentage of participants]	97.3 63.6%

72. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Embolic Events
Description	Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Number [percentage of participants]	96.5 63.1%

73. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
Description	Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.
Time Frame	1 month and 9 months

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure limbs	203
1 month	100.0
9 months	100.0

74. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure limbs	203
Number [percentage of target limbs]	100.0

75. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure limbs	203
Number [percentage of target limbs]	100.0

76. Secondary Outcome

Title	Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
Description	Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	153
Measure limbs	203
Number [percentage of target limbs]	99.4

77. Secondary Outcome

Title	Stent Thrombosis
Description	Defined as a total occlusion documented by duplex ultrasound and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	151
Measure lesions	201
Number (95% Confidence Interval) [percentage of target lesions]	0.5

78. Secondary Outcome

Title	Changes in Quality of Life Measures: Physical Component Summary
Description	This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame	Baseline and 1 month

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	132
Mean (Standard Deviation) [score on a scale]	10.4 (11.3)

79. Secondary Outcome

Title	Changes in Quality of Life Measures: Physical Component Summary
Description	This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame	Baseline and 9 months

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	136
Mean (Standard Deviation) [score on a scale]	9.8 (11.5)

80. Secondary Outcome

Title	Changes in Quality of Life Measures: Physical Component Summary
Description	This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	112
Mean (Standard Deviation) [score on a scale]	8.2 (12.7)

81. Secondary Outcome

Title	Changes in Quality of Life Measures: Physical Component Summary
Description	This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame	Baseline and 3 years

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	108
Mean (Standard Deviation) [score on a scale]	8.9 (13.7)

82. Secondary Outcome

Title	Changes in Quality of Life Measures: Mental Component Summary
Description	This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame	Baseline and 1 month

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	132
Mean (Standard Deviation) [score on a scale]	2.3 (10.7)

83. Secondary Outcome

Title	Changes in Quality of Life Measures: Mental Component Summary
Description	This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame	Baseline and 9 months

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	136
Mean (Standard Deviation) [score on a scale]	0.9 (11.7)

84. Secondary Outcome

Title	Changes in Quality of Life Measures: Mental Component Summary
Description	This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	112
Mean (Standard Deviation) [score on a scale]	2.2 (12.1)

85. Secondary Outcome

Title	Changes in Quality of Life Measures: Mental Component Summary
Description	This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time Frame	Baseline and 3 years

Outcome Measure Data

Analysis Population Description

ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Measure Participants	108
Mean (Standard Deviation) [score on a scale]	-0.5 (13.4)

Adverse Events

Time Frame	3 years
Adverse Event Reporting Description	Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Arm/Group Title	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Arm/Group Description	Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
All Cause Mortality
	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
	Affected / at Risk (%)	# Events
Total	94/153 (61.4%)
Blood and lymphatic system disorders
Anemia	9/153 (5.9%)	10
Cardiac disorders
Angina	2/153 (1.3%)	2
Arrhythmias (other than bradycardia)	7/153 (4.6%)	8
Cardiac / Hemodynamic	1/153 (0.7%)	1
Cardiac Arrest	2/153 (1.3%)	2
Congestive Heart Failure	5/153 (3.3%)	5
Myocardial Infarction - Non-Q- wave	1/153 (0.7%)	1
Myocardial Infarction - Q- wave	1/153 (0.7%)	1
Other: Arrhythmia	1/153 (0.7%)	1
Other: Chest Pain	1/153 (0.7%)	1
Other: Coronary Artery Disease	11/153 (7.2%)	11
Pain	1/153 (0.7%)	1
Bradycardia	2/153 (1.3%)	2
Congestive Heart Failure	2/153 (1.3%)	2
Hypertension	3/153 (2%)	6
Hypotension	4/153 (2.6%)	4
Pulmonary Edema	1/153 (0.7%)	1
Syncope	3/153 (2%)	3
Myocardial Infarction - Non-Q- wave	2/153 (1.3%)	2
Myocardial Infarction - Unknown	3/153 (2%)	3
Other: Myocardial Infarction - Non-Q Wave	1/153 (0.7%)	1
Gastrointestinal disorders
Diarrhea	1/153 (0.7%)	1
GI Bleed	7/153 (4.6%)	7
Gastro-intestinal	4/153 (2.6%)	5
Infection	1/153 (0.7%)	1
Nausea	3/153 (2%)	4
Other: Abdominal Pain	1/153 (0.7%)	2
Other: Cholecystitis	3/153 (2%)	3
Other: Cholelithiasis	1/153 (0.7%)	1
Other: Dehydration	1/153 (0.7%)	1
Other: Diabetic Gastroparesis	1/153 (0.7%)	1
Other: Duodenal Ulcer	1/153 (0.7%)	1
Other: Incisional Hernia	1/153 (0.7%)	1
Other: Pancreatitis	1/153 (0.7%)	2
Pain	2/153 (1.3%)	2
Surgery/Interventional Procedure	1/153 (0.7%)	1
General disorders
Edema (non pulmonary)	2/153 (1.3%)	2
Genito-urinary	1/153 (0.7%)	1
Other	1/153 (0.7%)	1
Other: Acquired Spondylolistheses	1/153 (0.7%)	1
Other: Frequent Falls	1/153 (0.7%)	1
Other: Lethargy	1/153 (0.7%)	1
Other: Multi Organ Failure	1/153 (0.7%)	1
Other: Shingles	1/153 (0.7%)	1
Other: Trauma	1/153 (0.7%)	1
Surgery/Interventional Procedure	1/153 (0.7%)	1
Infections and infestations
Gastro-intestinal	1/153 (0.7%)	1
Infection	1/153 (0.7%)	2
Other: Abscess	1/153 (0.7%)	2
Other: Bronchitis	1/153 (0.7%)	1
Other: Cellulitis	3/153 (2%)	4
Pneumonia	14/153 (9.2%)	21
Respiratory	2/153 (1.3%)	2
Sepsis	1/153 (0.7%)	1
Wound complication or wound infection	2/153 (1.3%)	2
Injury, poisoning and procedural complications
Hematoma	1/153 (0.7%)	1
Pseudoaneurysm	1/153 (0.7%)	1
Bleeding	1/153 (0.7%)	1
Hematoma	1/153 (0.7%)	1
Dissection	2/153 (1.3%)	2
Distal Emboli	1/153 (0.7%)	1
Metabolism and nutrition disorders
Other: Acidosis	1/153 (0.7%)	1
Other: Fatigue	1/153 (0.7%)	1
Other: Hypocalcemia	1/153 (0.7%)	1
Other: Hypokalemia	1/153 (0.7%)	1
Other: Hyponatremia	2/153 (1.3%)	5
Musculoskeletal and connective tissue disorders
Musculoskeletal	16/153 (10.5%)	17
Hematoma	1/153 (0.7%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	10/153 (6.5%)	11
Nervous system disorders
Mental Status Change	3/153 (2%)	4
Other: Anoxic Injury	1/153 (0.7%)	1
Seizure	1/153 (0.7%)	1
Transient Ischemic Attack	4/153 (2.6%)	4
Vision disturbance	1/153 (0.7%)	1
Renal and urinary disorders
Renal Failure	2/153 (1.3%)	2
Renal Insufficiency	1/153 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease	9/153 (5.9%)	16
Embolism	1/153 (0.7%)	1
Infection	1/153 (0.7%)	1
Other: Pleural Effusion	2/153 (1.3%)	2
Pulmonary Edema	1/153 (0.7%)	1
Other: Acute Exacerbation Asthma	1/153 (0.7%)	1
Other: Atelectasis	1/153 (0.7%)	1
Other: Dyspnea	1/153 (0.7%)	1
Other: Shortness Of Breath	4/153 (2.6%)	6
Respiratory Failure	9/153 (5.9%)	13
Viral, bacterial and fungal infections	1/153 (0.7%)	1
Vascular disorders
Other: CVA	1/153 (0.7%)	1
Other: Cerebral Vascular Accident	2/153 (1.3%)	2
Other: Lacunar Stroke	1/153 (0.7%)	1
Other: Stroke	1/153 (0.7%)	1
Dissection	2/153 (1.3%)	2
Gastro-intestinal	1/153 (0.7%)	1
Ischemia	2/153 (1.3%)	4
Occlusion	5/153 (3.3%)	7
Other: Aortic Iliac	1/153 (0.7%)	1
Other: Carotid Artery Disease	1/153 (0.7%)	1
Other: Deep Vein Thrombosis	3/153 (2%)	3
Other: Peripheral Vascular Disease	10/153 (6.5%)	12
Other: Stenosis	1/153 (0.7%)	1
Pain	1/153 (0.7%)	2
Pulmonary Embolism	1/153 (0.7%)	1
Renal	1/153 (0.7%)	1
Restenosis	14/153 (9.2%)	16
Stenosis	25/153 (16.3%)	44
Stent Thrombosis	1/153 (0.7%)	1
Surgery/Interventional Procedure	2/153 (1.3%)	2
Thrombosis	2/153 (1.3%)	2
Other (Not Including Serious) Adverse Events
	Omnilink Elite™ Peripheral Balloon-Expandable Stent System
	Affected / at Risk (%)	# Events
Total	84/153 (54.9%)
Blood and lymphatic system disorders
Anemia	8/153 (5.2%)	9
Cardiac disorders
Hypertension	8/153 (5.2%)	9
General disorders
Edema (non pulmonary)	13/153 (8.5%)	15
Musculoskeletal and connective tissue disorders
Musculoskeletal	48/153 (31.4%)	78
Respiratory, thoracic and mediastinal disorders
Other: Shortness Of Breath	8/153 (5.2%)	8
Vascular disorders
Other: Peripheral Vascular Disease	21/153 (13.7%)	23
Stenosis	17/153 (11.1%)	17

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.