Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX)

• Sponsor: W.L.Gore & Associates (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01961167
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arm: 1
• Actual Duration (Months): 48.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The primary objective of the VBX13-05 clinical study is to evaluate the safety and efficacy of VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.

Condition or Disease	Intervention/Treatment	Phase
Common Iliac Artery Occlusive Disease; External Iliac Artery Occlusive Disease; Peripheral Arterial Disease	Device: Stenting of common and/or external iliacs	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single group assignmentSingle group assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries
• Actual Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Dec 14, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gore VIABAHN BX Balloon expandable stenting of iliac occlusive disease	Device: Stenting of common and/or external iliacs; Balloon expandable stenting of iliac occlusive disease

Outcome Measures

Primary Outcome Measures

1. Composite of Major Adverse Events (MAEs) [30 days]

   Percentage of study subjects experiencing a major adverse event (MAE) defined as: Device- or procedure-related death within 30 days of the index procedure; and Myocardial Infarction (MI) occurring within 30 days of the index procedure; and Amputation above the metatarsals in the treated leg, resulting from a vascular event, occurring within 30 days of the index procedure.

Secondary Outcome Measures

1. Acute Procedural Success [Discharge]

   Number of subjects who experience acute procedural success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge at day 1.

2. Thirty-day Clinical Success [30 Days]

   Number of subjects who experienced 30-day clinical success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related serious adverse events (SAEs) within 30 days of the index procedure. Rutherford categories include: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

3. Primary Patency [30 Days]

   Kaplan-Meier estimate of primary patency at 30 days. Primary patency is defined as blood flow in the treated segment(s), without reintervention.

4. Primary Patency [6 Months]

   Kaplan-Meier estimate of primary patency at 6 months. Primary patency is defined as blood flow in the treated segment(s), without reintervention.

5. Primary Assisted Patency [30 Days]

   Kaplan-Meier estimate of primary assisted patency at 30 days. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.

6. Primary Assisted Patency [6 Months]

   Kaplan-Meier estimate of primary assisted patency at 6 Months. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.

7. Secondary Patency [30 Days]

   Kaplan-Meier estimate of secondary patency at 30 days. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.

8. Secondary Patency [6 Months]

   Kaplan-Meier estimate of secondary patency at 6 months. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.

9. Freedom From Target Lesion(s) Revascularization (TLR) [30 Days]

   Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.

10. Freedom From Target Lesion(s) Revascularization (TLR) [6 Months]

    Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 6 months. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.

11. Freedom From Target Vessel Revascularization (TVR) [30 Days]

    Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.

12. Freedom From Target Vessel Revascularization (TVR) [6 Months]

    Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 6 months. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.

13. Number of Participants With a Change in Rutherford Category [30 Days]

    Change in Rutherford Category from pre-procedure at 30 days. Rutherford categories include: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

14. Number of Participants With Change in Rutherford Category [6 Months]

    Change in Rutherford Category from pre-procedure at 6 months. Rutherford categories include: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

15. Change in Ankle Brachial Index (ABI) [30 Days]

    Change in Ankle Brachial Index (ABI) from pre-procedure at 30 days. Larger values indicate a better outcome. The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm

16. Change in Ankle Brachial Index (ABI) [6 Months]

    Change in Ankle Brachial Index(ABI) from pre-procedure at 6 months. Larger values indicate a better outcome.The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm

17. Freedom From Major Adverse Events (MAEs) [6 months]

    Number of subjects experiencing freedom from procedure- or device-related events causing death, occurring within 30 days of the index procedure; and myocardial infarction (MI) occurring within 30 days of the index procedure; and target lesion revascularization (TLR) occurring within 6 months of the index procedure; and major amputation of the treated leg(s), resulting from a vascular event, occurring within 6 months of the index procedure.

18. Change in Functional Status - EQ5D- Mobility [30 days]

    Change in functional status (EQ5D - Mobility) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.

19. Change in Functional Status - EQ5D- Mobility [6 Months]

    Change in functional status (EQ5D - Mobility) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.

20. Change in Functional Status - EQ5D - Self Care [30 days]

    Change in functional status (EQ5D - Self Care) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.

21. Change in Functional Status - EQ5D - Self Care [6 Months]

    Change in functional status (EQ5D - Self Care) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.

22. Change in Functional Status - EQ5D - Usual Activities [30 days]

    Change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.

23. Change in Functional Status - EQ5D - Usual Activities [6 Months]

    Change in functional status (EQ5D - Usual Activities) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.

24. Change in Functional Status - EQ5D - Pain/Discomfort [30 Days]

    Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.

25. Change in Functional Status - EQ5D - Pain/Discomfort [6 Months]

    Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.

26. Change in Functional Status - EQ5D - Anxiety/Depression [30 Days]

    Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.

27. Change in Functional Status - EQ5D - Anxiety/Depression [6 Months]

    Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.

28. Change in Functional Status - EQ5D- Own Health State [30 Days]

    Change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.

29. Change in Functional Status - EQ5D- Own Health State [6 Months]

    Change in functional status (EQ5D - Own Health State) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.

30. Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ) [30 day]

    Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.

31. Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ) [6 Months]

    Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 180 days.

Other Outcome Measures

1. Device or Procedure-related Death [30 Days]

   Number of subjects experiencing a device or procedure-related death within 30 days - component of primary outcome.

2. Freedom From Myocardial Infarction (MI) [30 Days]

   Number of subjects experiencing a myocardial infarction (MI) within 30 days - component of primary outcome.

3. Freedom From Major Amputation of the Treated Leg(s) [6 Months]

   Number of subjects experiencing a major amputation of the treated leg(s), resulting from a vascular event within 6 months - component

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient is at least 18 years old;

• Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;

• Patient or legal representative is willing to give written informed consent;

• Patient is capable of complying with protocol requirements, including all follow-up visits;

• Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).

• Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery

Exclusion Criteria:

• Patient has a life expectancy of less than 1 year;

• Patient has a known allergy to stent graft components, including stainless steel or heparin;

• Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;

• Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation

• Patient has had vascular access / catheterization in the lower extremity within 30 days of study enrollment;

• Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure; Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the study procedure;

• Patient is currently participating in this or another investigative clinical study.

• Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);

• Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;

• Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;

• Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Auckland City Hospital	Auckland		New Zealand

Sponsors and Collaborators

• W.L.Gore & Associates

Investigators

• Principal Investigator: Andrew Holden, MB ChB, Auckland City Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT01961167
• Other Study ID Numbers: VBX 13-05
• First Posted: Oct 11, 2013
• Last Update Posted: Nov 19, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by W.L.Gore & Associates: PAD; Stent; Claudication; VIABAHN; Gore; Endoprosthesis; Vascular Diseases; Cardiovascular Diseases; Iliac Occlusive Disease; Balloon Expandable; Stent Graft; VBX
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases

Study Results

Participant Flow

Arm/Group Title	Gore VIABAHN BX
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Period Title: Overall Study
STARTED	27
COMPLETED	27
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Overall Participants	27
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	65 (8.4)
Sex: Female, Male (Count of Participants)
Female	10 37%
Male	17 63%
Region of Enrollment (Count of Participants)
New Zealand	27 100%

Outcome Measures

1. Primary Outcome

Title	Composite of Major Adverse Events (MAEs)
Description	Percentage of study subjects experiencing a major adverse event (MAE) defined as: Device- or procedure-related death within 30 days of the index procedure; and Myocardial Infarction (MI) occurring within 30 days of the index procedure; and Amputation above the metatarsals in the treated leg, resulting from a vascular event, occurring within 30 days of the index procedure.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Population includes enrolled subjects who either experienced the defined event or were followed for at least 30 days.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Number (95% Confidence Interval) [percentage of subjects experiencing MAE]	0

2. Secondary Outcome

Title	Acute Procedural Success
Description	Number of subjects who experience acute procedural success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge at day 1.
Time Frame	Discharge

Outcome Measure Data

Analysis Population Description

Population includes subjects followed through discharge at day 1 and had relevant procedural data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Count of Participants [Participants]	27 100%

3. Secondary Outcome

Title	Thirty-day Clinical Success
Description	Number of subjects who experienced 30-day clinical success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related serious adverse events (SAEs) within 30 days of the index procedure. Rutherford categories include: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 30 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Count of Participants [Participants]	25 92.6%

4. Secondary Outcome

Title	Primary Patency
Description	Kaplan-Meier estimate of primary patency at 30 days. Primary patency is defined as blood flow in the treated segment(s), without reintervention.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Analysis includes subjects followed for at least 30 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Number (95% Confidence Interval) [percentage of lesions]	100

5. Secondary Outcome

Title	Primary Patency
Description	Kaplan-Meier estimate of primary patency at 6 months. Primary patency is defined as blood flow in the treated segment(s), without reintervention.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 180 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Number (95% Confidence Interval) [percentage of lesions]	100

6. Secondary Outcome

Title	Primary Assisted Patency
Description	Kaplan-Meier estimate of primary assisted patency at 30 days. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 30 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Number (95% Confidence Interval) [percentage of lesions]	100

7. Secondary Outcome

Title	Primary Assisted Patency
Description	Kaplan-Meier estimate of primary assisted patency at 6 Months. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 180 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Number (95% Confidence Interval) [Lesions]	100

8. Secondary Outcome

Title	Secondary Patency
Description	Kaplan-Meier estimate of secondary patency at 30 days. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 30 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Number (95% Confidence Interval) [percentage of lesions]	100

9. Secondary Outcome

Title	Secondary Patency
Description	Kaplan-Meier estimate of secondary patency at 6 months. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 180 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Number (95% Confidence Interval) [percentage of lesions]	100

10. Secondary Outcome

Title	Freedom From Target Lesion(s) Revascularization (TLR)
Description	Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 30 days.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Number (95% Confidence Interval) [percentage of lesions]	100

11. Secondary Outcome

Title	Freedom From Target Lesion(s) Revascularization (TLR)
Description	Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 6 months. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 180 days.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Number (95% Confidence Interval) [percentage of lesions]	100

12. Secondary Outcome

Title	Freedom From Target Vessel Revascularization (TVR)
Description	Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 30 days.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Number (95% Confidence Interval) [Vessel]	100

13. Secondary Outcome

Title	Freedom From Target Vessel Revascularization (TVR)
Description	Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 6 months. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 180 days.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Number (95% Confidence Interval) [percentage of vessel]	100

14. Secondary Outcome

Title	Number of Participants With a Change in Rutherford Category
Description	Change in Rutherford Category from pre-procedure at 30 days. Rutherford categories include: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 23 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Improved	25 92.6%
Maintained	1 3.7%
Worsened	1 3.7%

15. Secondary Outcome

Title	Number of Participants With Change in Rutherford Category
Description	Change in Rutherford Category from pre-procedure at 6 months. Rutherford categories include: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 150 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	22
Improved	19 70.4%
Maintained	1 3.7%
Worsended	2 7.4%

16. Secondary Outcome

Title	Change in Ankle Brachial Index (ABI)
Description	Change in Ankle Brachial Index (ABI) from pre-procedure at 30 days. Larger values indicate a better outcome. The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 23 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Measure limbs	39
Mean (Full Range) [ratio]	.15

17. Secondary Outcome

Title	Change in Ankle Brachial Index (ABI)
Description	Change in Ankle Brachial Index(ABI) from pre-procedure at 6 months. Larger values indicate a better outcome.The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 150 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Measure limbs	33
Mean (Full Range) [ratio]	.15

18. Secondary Outcome

Title	Freedom From Major Adverse Events (MAEs)
Description	Number of subjects experiencing freedom from procedure- or device-related events causing death, occurring within 30 days of the index procedure; and myocardial infarction (MI) occurring within 30 days of the index procedure; and target lesion revascularization (TLR) occurring within 6 months of the index procedure; and major amputation of the treated leg(s), resulting from a vascular event, occurring within 6 months of the index procedure.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Population includes number of subjects enrolled into the study who either had defined event or were followed for at least 150 days.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Count of Participants [Participants]	27 100%

19. Secondary Outcome

Title	Change in Functional Status - EQ5D- Mobility
Description	Change in functional status (EQ5D - Mobility) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 23 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	26
Improved	12 44.4%
Maintained	12 44.4%
Worsened	2 7.4%

20. Secondary Outcome

Title	Change in Functional Status - EQ5D- Mobility
Description	Change in functional status (EQ5D - Mobility) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Patient population includes subjects followed for at least 150 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	23
Improved	10 37%
Maintained	10 37%
Worsened	3 11.1%

21. Secondary Outcome

Title	Change in Functional Status - EQ5D - Self Care
Description	Change in functional status (EQ5D - Self Care) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 23 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	26
Improved	0 0%
Maintained	26 96.3%
Worsened	0 0%

22. Secondary Outcome

Title	Change in Functional Status - EQ5D - Self Care
Description	Change in functional status (EQ5D - Self Care) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 150 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	23
Improved	0 0%
Maintained	22 81.5%
Worsened	1 3.7%

23. Secondary Outcome

Title	Change in Functional Status - EQ5D - Usual Activities
Description	Change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 23 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	26
Improved	13 48.1%
Maintained	12 44.4%
Worsened	1 3.7%

24. Secondary Outcome

Title	Change in Functional Status - EQ5D - Usual Activities
Description	Change in functional status (EQ5D - Usual Activities) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 150 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	23
Improved	8 29.6%
Maintained	14 51.9%
Worsened	1 3.7%

25. Secondary Outcome

Title	Change in Functional Status - EQ5D - Pain/Discomfort
Description	Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 30 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	26
Improved	14 51.9%
Maintained	10 37%
Worsened	2 7.4%

26. Secondary Outcome

Title	Change in Functional Status - EQ5D - Pain/Discomfort
Description	Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 150 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	23
Improved	10 37%
Maintained	12 44.4%
Worsened	1 3.7%

27. Secondary Outcome

Title	Change in Functional Status - EQ5D - Anxiety/Depression
Description	Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 30 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	26
Improved	5 18.5%
Maintained	20 74.1%
Worsened	1 3.7%

28. Secondary Outcome

Title	Change in Functional Status - EQ5D - Anxiety/Depression
Description	Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 150 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	23
Improved	2 7.4%
Maintained	21 77.8%
Worsened	0 0%

29. Secondary Outcome

Title	Change in Functional Status - EQ5D- Own Health State
Description	Change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 30 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	25
Improved	4 14.8%
Maintained	19 70.4%
Worsened	2 7.4%

30. Secondary Outcome

Title	Change in Functional Status - EQ5D- Own Health State
Description	Change in functional status (EQ5D - Own Health State) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 150 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	22
Improved	3 11.1%
Maintained	17 63%
Worsened	2 7.4%

31. Secondary Outcome

Title	Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ)
Description	Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.
Time Frame	30 day

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 30 days and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	26
Count of Participants [Participants]	20 74.1%

32. Secondary Outcome

Title	Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ)
Description	Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 180 days.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 6 Months and had relevant data.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	23
Count of Participants [Participants]	17 63%

33. Other Pre-specified Outcome

Title	Device or Procedure-related Death
Description	Number of subjects experiencing a device or procedure-related death within 30 days - component of primary outcome.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 30 days.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Count of Participants [Participants]	0 0%

34. Other Pre-specified Outcome

Title	Freedom From Myocardial Infarction (MI)
Description	Number of subjects experiencing a myocardial infarction (MI) within 30 days - component of primary outcome.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 30 days.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Count of Participants [Participants]	0 0%

35. Other Pre-specified Outcome

Title	Freedom From Major Amputation of the Treated Leg(s)
Description	Number of subjects experiencing a major amputation of the treated leg(s), resulting from a vascular event within 6 months - component
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Population includes subjects followed for at least 150 days.

Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
Measure Participants	27
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	Through 6 months
Arm/Group Title	Iliac Stenting
Arm/Group Description	Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease
All Cause Mortality
	Iliac Stenting
	Affected / at Risk (%)	# Events
Total	0/27 (0%)
Serious Adverse Events
	Iliac Stenting
	Affected / at Risk (%)	# Events
Total	2/27 (7.4%)
Injury, poisoning and procedural complications
Arterial restenosis	1/27 (3.7%)	1
Vascular disorders
Leg ischemia	1/27 (3.7%)	1
Other (Not Including Serious) Adverse Events
	Iliac Stenting
	Affected / at Risk (%)	# Events
Total	0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.