The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent

Study Overview
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Brief Summary
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This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C & D superficial femoral artery long lesions (up to 22 cm) in comparison with the Bard® Luminexx™ 6F Vascular Stent as determined by the primary patency rate at 6 and 12 months post procedure.

Detailed Description
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This is a German multi-center prospective, randomized, two-arm study evaluating performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System as compared to the C.R. Bard® Luminexx™ 6F Vascular Stent. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 200 patients will be entered into the study. The study population will consist of approximately 200 symptomatic peripheral vascular disease patients with TASC C & D SFA lesions. The disease will consist of symptomatic, long de novo or restenotic lesions (> 70% stenosis) and occlusions (5 - 22 cm) on diagnostic imaging. The lesion must not extend into the distal SFA and the popliteal artery. At least one distal popliteal artery must be patent as well as one calf vessel. Reference vessel diameter must be >= 4.0 to <= 6.0 mm. Trial participants will be randomized to the Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System or to the Bard® Luminexx™ 6F Vascular Stent. 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 over up to 15 investigational sites in Germany.

Official Title
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A Clinical Investigation of the Cordis S.M.A.R.T. ™ CONTROL ™ Nitinol Stent System Versus the Bard® Luminexx™ 6F Vascular Stent for the Treatment of TASC C & D Superficial Femoral Artery Long Lesions

Conditions
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Arterial Occlusive Diseases

Intervention / Treatment
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* Device: Smart Stent
* Device: Luminexx Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic leg ischemia by Rutherford classification (category 2, 3, 4 or 5); duration of intermittent claudication (category 2-3) should be at least 3 months. One superficial femoral artery de novo or restenotic lesion (more than 70% stenosis or occlusions), with a lesion length of more than 5 to less than 22 cm. Patent popliteal artery on the index side, i.e., single vessel runoff or better with at least one of three vessels patent to the lower 1/3 of the calf prior to the day of the procedure. Exclusion Criteria: Revascularisation involving the same limb within 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure. Patients having total occlusions of the iliac artery on the same side must be excluded. Previously implanted stent(s) in the to be treated artery at the same site. Requiring stent placement in the distal superficial femoral artery and the popliteal artery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 S.M.A.R.T.™ CONTROL™ Nitinol Stent System | Device: Smart Stent<br>* Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System<br>|
| Active Comparator: 2<br>Bard® Luminexx™ 6F Vascular Stent | Device: Luminexx Stent<br>* Bard® Luminexx™ 6F Vascular Stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary patency detectable by duplex ultrasound through the index lesion |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technical success |  | time of deployment | 
| procedural success |  | up to removal of catheter sheath | 
| procedural complications |  | up to removal of catheter sheath | 
| Ankle Brachial Index |  | discharge and 12 months | 
| primary patency |  | 6 months | 
| binary restenosis |  | 6 and 12 months | 
| stent fractures |  | 6 and 12 months | 
| target lesion revascularisation |  | 6 and 12 months | 
| target vessel revascularisation |  | 6 and 12 months | 
| adverse events |  | baseline, discharge, 6 and 12 months post procedure | 
| clinical categorization of chronic limb ischemia by means of the Rutherford classification |  | discharge, 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