Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)

• Sponsor: Medtronic Endovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00880230
• Collaborator: (none)
• Enrollment: 141
• Locations: 3
• Arm: 1
• Duration (Months): 45
• Patients Per Site: 47
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and effectiveness of the Scuba™ stent in subjects with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease	Device: Scuba Iliac Stent System	N/A

Detailed Description

Interventional revascularization strategies for peripheral arterial disease currently available include both surgical and endovascular approaches such as percutaneous transluminal angioplasty (PTA), either as a stand-alone procedure or with the placement of a stent. Cobalt-chromium (CoCr) is an alloy that has been used safely in the manufacture of surgical implants for use in contact with blood, soft tissue and bone for over 10 years. This study will evaluate the SCUBA™ peripheral balloon-expandable cobalt chromium tent system in iliac arteries.

Study Design

• Study Type: Interventional
• Actual Enrollment: 141 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: INTENSE: Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Scuba Iliac Stent System Device: Scuba™ iliac stent	Device: Scuba Iliac Stent System; The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.; Other Names: Scuba

Outcome Measures

Primary Outcome Measures

1. Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure. [In-hospital and 9 Months]

   The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days.

Secondary Outcome Measures

1. Major Adverse Vascular Events Through 30 Days as a Composite of (MI, Death or Stroke, Stent Thrombosis, Distal Embolization, Arterial Rupture/Perforation, Acute Limb Ischemia, Target Limb Loss, Procedure-related Bleeding Event Requiring Transfusion) [30 Days]

   The analysis is based on the number of patients who experienced either an MI, died, had a stroke, stent thrombosis, distal embolization, arterial rupture/perforation limb ischemia, lost a target limb, or had a bleeding event due to the procedure within 30 days after being treated with the Scuba iliac stent.

2. Device Success [At time of deployment]

   The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system.

3. Procedural Success [Up to the moment the catheter sheath introducer has been removed]

   The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system [Device Success] and the achievement of <30% residual stenosis immediately after stent deployment, without occurrence of in-hospital Major Adverse Events (MAE).

4. Clinical Success [30 Days]

   Early Clinical Success (30 days) is defined as improvement of the Rutherford-Becker scale criteria by greater than or equal to one category as obtained at the 30 day follow-up visit.

5. Clinical Success [6 Months]

   Late Clinical Success (6 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.

6. Clinical Success [9 Months]

   Late Clinical Success (9 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.

7. Patency - Primary [6 Months]

   Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months.

8. Patency - Primary Assisted [6 Months]

   Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 6 months.

9. Patency - Secondary [6 Months]

   Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 6 months.

10. Patency - Primary [9 Months]

    Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months.

11. Patency - Primary Assisted [9 Months]

    Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 9 months.

12. Patency - Secondary [9 Months]

    Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 9 months.

13. Target Limb Revascularization [9 Months]

    Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.

14. Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination) [9 Months]

    Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.

15. Death [9 Months]

    Death can be classified as one of three categories: cardiac, vascular, or non-cardiovascular. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established.

16. Target Limb Loss [9 Months]

    Amputation of the target limb by surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target segment. Amputations are subclassified as: Above the knee, Below the knee, Transmetatarsal, and Toe.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Presence of de novo or restenotic lesion(s), located in the common or external iliac artery with ≥50% stenosis

• Subject has lifestyle limiting claudication or rest pain, (Rutherford- Becker scale [clinical category] 2, 3, or 4)

• Target vessel reference diameter is 5mm - 10mm by visual assessment

• Target lesion length < 130mm

• Subject has angiographic evidence of a patent femoral outflow artery in the target limb

• Subject has provided written informed consent

• Subject is able and willing to adhere to required follow-up visits and testing

Exclusion Criteria:

• Subject has lesions in the Common Femoral Artery (CFA), Profundal Femoral Artery (PFA), or Superficial Femoral Artery (SFA) that would require a staged procedure within 30 days of the index procedure (either before or after)

• Target lesion(s) has adjacent, acute thrombus

• Target lesion(s) is highly calcified or was previously treated with a stent

• Subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery

• Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion

• Subject has a post-surgical stenosis and anastomotic suture treatments in the native iliac vessel

• Subject has a vascular graft previously implanted in the native iliac vessel

• Subject has tissue loss - Rutherford-Becker clinical category 5 or 6

• History of neutropenia (WBC <3,000/mm3), coagulopathy, or thrombocytopenia (platelet count <80,000/uL)

• International Normalized ratio (INR) greater than 1.5

• Serum creatinine greater than 2.5 mg/dL

• Subject has a known bleeding or hypercoagulability disorder or significant anemia (Hb < 8.0 g/dL) that cannot be corrected

• Subject is participating in an investigational study of a new drug, biologic, or device at the same time of study screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Hospital of Miami	Miami	Florida	United States	33176
2	Greenville Hospital System	Greenville	South Carolina	United States	29605
3	Hamburg University Cardiovascular Center	Hamburg		Germany	22527

Sponsors and Collaborators

• Medtronic Endovascular

Investigators

• Principal Investigator: Bruce H Gray, DO, Greeville Health System
• Principal Investigator: Barry T Katzen, MD, Baptist Health South Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Endovascular
• ClinicalTrials.gov Identifier: NCT00880230
• Other Study ID Numbers: P-999
• First Posted: Apr 13, 2009
• Last Update Posted: Feb 26, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Medtronic Endovascular: Iliac Artery Stenting; Peripheral Artery Disease
• Additional relevant MeSH terms: Peripheral Arterial Disease

Study Results

Participant Flow

Recruitment Details	Recruitment was for a period of 16 months. Subjects were recruited at medical clinics who participate in clinical trials.

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba Iliac Stent Scuba Iliac Stent System: The Scuba Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Period Title: Overall Study
STARTED	141
COMPLETED	134
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ Iliac stent Scuba Iliac Stent System: The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Overall Participants	141
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	85 60.3%
>=65 years	56 39.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.90 (9.55)
Sex: Female, Male (Count of Participants)
Female	33 23.4%
Male	108 76.6%
Region of Enrollment (participants) [Number]
United States	59 41.8%
Germany	70 49.6%
Switzerland	12 8.5%

Outcome Measures

1. Primary Outcome

Title	Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure.
Description	The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days.
Time Frame	In-hospital and 9 Months

Outcome Measure Data

Analysis Population Description

Intent to Treat Population (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Participants]	5.2 3.7%

2. Secondary Outcome

Title	Major Adverse Vascular Events Through 30 Days as a Composite of (MI, Death or Stroke, Stent Thrombosis, Distal Embolization, Arterial Rupture/Perforation, Acute Limb Ischemia, Target Limb Loss, Procedure-related Bleeding Event Requiring Transfusion)
Description	The analysis is based on the number of patients who experienced either an MI, died, had a stroke, stent thrombosis, distal embolization, arterial rupture/perforation limb ischemia, lost a target limb, or had a bleeding event due to the procedure within 30 days after being treated with the Scuba iliac stent.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Intent to Treat Population (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	2.2

3. Secondary Outcome

Title	Device Success
Description	The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system.
Time Frame	At time of deployment

Outcome Measure Data

Analysis Population Description

Intent to Treat Population (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	95

4. Secondary Outcome

Title	Procedural Success
Description	The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system [Device Success] and the achievement of <30% residual stenosis immediately after stent deployment, without occurrence of in-hospital Major Adverse Events (MAE).
Time Frame	Up to the moment the catheter sheath introducer has been removed

Outcome Measure Data

Analysis Population Description

Intention to Treat Population (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	86.5

5. Secondary Outcome

Title	Clinical Success
Description	Early Clinical Success (30 days) is defined as improvement of the Rutherford-Becker scale criteria by greater than or equal to one category as obtained at the 30 day follow-up visit.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Intention to Treat Population (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	93.8

6. Secondary Outcome

Title	Clinical Success
Description	Late Clinical Success (6 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat Population (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	69.3

7. Secondary Outcome

Title	Clinical Success
Description	Late Clinical Success (9 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.
Time Frame	9 Months

Outcome Measure Data

Analysis Population Description

Intent to Treat Population (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	66.4

8. Secondary Outcome

Title	Patency - Primary
Description	Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat Population (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	94.9

9. Secondary Outcome

Title	Patency - Primary Assisted
Description	Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 6 months.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	1.5

10. Secondary Outcome

Title	Patency - Secondary
Description	Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 6 months.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat Population (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	3.7

11. Secondary Outcome

Title	Patency - Primary
Description	Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months.
Time Frame	9 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	95.3

12. Secondary Outcome

Title	Patency - Primary Assisted
Description	Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 9 months.
Time Frame	9 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	1.9

13. Secondary Outcome

Title	Patency - Secondary
Description	Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 9 months.
Time Frame	9 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat Population (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	1.9

14. Secondary Outcome

Title	Target Limb Revascularization
Description	Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.
Time Frame	9 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat Population (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	7.5

15. Secondary Outcome

Title	Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination)
Description	Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.
Time Frame	9 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	1.9

16. Secondary Outcome

Title	Death
Description	Death can be classified as one of three categories: cardiac, vascular, or non-cardiovascular. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established.
Time Frame	9 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat Population (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	1.5

17. Secondary Outcome

Title	Target Limb Loss
Description	Amputation of the target limb by surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target segment. Amputations are subclassified as: Above the knee, Below the knee, Transmetatarsal, and Toe.
Time Frame	9 Months

Outcome Measure Data

Analysis Population Description

Intention to Treat Population (ITT)

Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Measure Participants	141
Number [Percentage of Patients]	0

Adverse Events

Time Frame	From subject index procedure through the 9 month follow-up visit period.
Adverse Event Reporting Description	In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Arm/Group Title	Scuba Iliac Stent System
Arm/Group Description	Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
All Cause Mortality
	Scuba Iliac Stent System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Scuba Iliac Stent System
	Affected / at Risk (%)	# Events
Total	47/141 (33.3%)
Blood and lymphatic system disorders
Anaemia	1/141 (0.7%)	1
Cardiac disorders
Acute Coronary Syndrome	3/141 (2.1%)	3
Acute Myocardial Infarction	1/141 (0.7%)	1
Angina Pectoris	4/141 (2.8%)	6
Angina Unstable	1/141 (0.7%)	2
Atrial Fibrilation	1/141 (0.7%)	1
Cardiac Arrest	1/141 (0.7%)	1
Coronary Artery Disease	1/141 (0.7%)	1
Coronary Artery Stenosis	2/141 (1.4%)	2
Ear and labyrinth disorders
Vertigo	1/141 (0.7%)	1
Gastrointestinal disorders
Abdominal Pain	1/141 (0.7%)	1
Gastric Ulcer	1/141 (0.7%)	1
Gastritis Erosive	1/141 (0.7%)	1
Pancreatitis	1/141 (0.7%)	2
General disorders
Catheter Site Haemorrhage	1/141 (0.7%)	1
Tenderness	1/141 (0.7%)	1
Infections and infestations
Pneumonia	3/141 (2.1%)	3
Post Procedural Infection	1/141 (0.7%)	1
Injury, poisoning and procedural complications
In-stent Arterial Restenosis	2/141 (1.4%)	3
Meniscus Lesion	1/141 (0.7%)	1
Stent Occlusion	1/141 (0.7%)	1
Thrombus in Device	1/141 (0.7%)	1
Wound	1/141 (0.7%)	1
Metabolism and nutrition disorders
Diabetic Ketoacidosis	1/141 (0.7%)	1
Musculoskeletal and connective tissue disorders
Arthritis	1/141 (0.7%)	1
Cervical Spinal Stenosis	1/141 (0.7%)	1
Intervertebral Disc Protrusion	1/141 (0.7%)	1
Musculoskeletal Pain	1/141 (0.7%)	1
Pain in Extremity	2/141 (1.4%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Recurrent	1/141 (0.7%)	1
Colon Cancer	1/141 (0.7%)	1
Lung Neoplasm Malignant	1/141 (0.7%)	1
Metastasis	1/141 (0.7%)	1
Oesophageal Carcinoma	1/141 (0.7%)	1
Prostate Cancer	1/141 (0.7%)	1
Rectal Cancer	1/141 (0.7%)	1
Nervous system disorders
Carotid Artery Stenosis	1/141 (0.7%)	1
Dizziness	1/141 (0.7%)	1
Psychiatric disorders
Bipolar Disorder	1/141 (0.7%)	1
Renal and urinary disorders
Calculus Ureteric	1/141 (0.7%)	1
Renal Artery Stenosis	1/141 (0.7%)	1
Renal Failure Acute	1/141 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/141 (0.7%)	1
Respiratory Failure	1/141 (0.7%)	1
Vascular disorders
Aortic Aneurysm	1/141 (0.7%)	1
Arterial Thrombus Limb	1/141 (0.7%)	2
Femoral Arterial Stenosis	3/141 (2.1%)	3
Hypertensive Emergency	1/141 (0.7%)	1
Iliac Artery Occlusion	1/141 (0.7%)	1
Iliac Artery Stenosis	1/141 (0.7%)	1
Iliac Artery Thrombosis	1/141 (0.7%)	1
Intermittent Claudication	7/141 (5%)	8
Leriche Syndrome	1/141 (0.7%)	1
Peripheral Artery Dissection	1/141 (0.7%)	2
Peripheral Embolism	1/141 (0.7%)	1
Peripheral Ischaemia	2/141 (1.4%)	2
Subclavian Artery Stenosis	1/141 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Scuba Iliac Stent System
	Affected / at Risk (%)	# Events
Total	35/141 (24.8%)
Cardiac disorders
Acute Coronary Syndrome	3/141 (2.1%)	3
Angina Pectoris	4/141 (2.8%)	7
General disorders
Catheter Site Haematoma	4/141 (2.8%)	4
Infections and infestations
Pneumonia	3/141 (2.1%)	3
Musculoskeletal and connective tissue disorders
Pain in Extremity	5/141 (3.5%)	6
Vascular disorders
Femoral Artery Stenosis	4/141 (2.8%)	4
Intermittent Claudication	9/141 (6.4%)	13
Peripheral Artery Dissection	3/141 (2.1%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Medtronic has a legitimate interest in ensuring that a multi-center publication is the first publication to be released regarding the completed Study. The Institution agrees that it will not publish or disclose any results of or information pertaining to the study until a multi-center publication is released. If a publication is not released within one year after completion of the study, the Institution will have the right to publish information pertaining to their activities conducted.