The Study to Compare the Treatment of Angioplasty and Stents in SFA Occlusions.

Study Overview
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Brief Summary
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The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only.

Detailed Description
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This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ nitinol self-expanding stent as compared to balloon angioplasty only. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study. The study population will consist of symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, long de novo or restenotic occlusions (5 - 14.5 cm) on diagnostic imaging with a history of at least 6 months. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. The distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels. Reference vessel diameter must be >= 4.0 to <= 6.0 mm. Trial participants will be randomized to the SMART™ nitinol self-expanding stent or to balloon angioplasty only. Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure. This study will be conducted at 8 investigational sites in The Netherlands.

Official Title
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A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty for the Treatment of Superficial Femoral Artery Occlusions

Conditions
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Arterial Occlusive Diseases

Intervention / Treatment
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* Device: stent
* Device: angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 6 months The patient should be suitable for percutaneous transluminal angioplasty (PTA) and also for stenting. Exclusion Criteria: Poor aortoiliac or common femoral inflow, which would be deemed inadequate to support a femoropopliteal bypass graft. Patient having total occlusions or severe stenosis of the iliac artery on the same side must be excluded. Gangrene in index limb (Rutherford category 6).

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cordis SMART™ Nitinol Stent | Device: stent<br>* Cordis SMART™ Nitinol Stent<br>|
| Active Comparator: 2<br>balloon angioplasty | Device: angioplasty<br>* balloon angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography. |  | at deployment | 
| Procedural success defined as successful recanalization, without the occurrence of a SAE. |  | up to the moment haemostasis has been achieved | 
| Procedural complications, defined as any adverse event |  | from start of the procedure up to the moment haemostasis has been achieved | 
| Ankle Brachial Index. |  | discharge and 12 months | 
| Treadmill test. |  | 12 months | 
| Restenosis measured by Duplex Ultrasound. |  | 12 months | 
| Quality of Life assessment. |  | baseline, 6, and 12 months post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Artery Occlusive Disease