A Study of the SMART Stent in the Treatment SFA Disease.

Study Overview
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Brief Summary
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The main objective of this study is to assess the safety and performance of the sirolimus coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the treatment of obstructive superficial femoral artery (SFA) disease in reducing percent in-stent mean lumen diameter stenosis in de novo or restenotic native lesions as compared to the uncoated SMART™ stent.

Detailed Description
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This is a multi-center, prospective, randomized, double blind, two-arm feasibility study evaluating the safety and performance of the sirolimus coated Cordis SMART™ nitinol self-expanding stent and delivery system as compared to the uncoated SMART™ stent and delivery system. It is anticipated that a total of 90 patients will be entered into the study. Patients will be randomized on a 1:1 basis of coated to uncoated stents. Ninety (90) patients with de novo or restenotic native SFA lesions will be randomized to the Sirolimus Coated SMART™ nitinol self-expanding stent or to the uncoated (bare) SMART™ stent. Patients will be followed for 24 months post-procedure, with all patients having duplex ultrasound and clinical assessments at discharge, 1, 6, 9, 18 and 24 months, angiography at 6 six months and plain X-ray at 18 months. This study will be conducted at nine investigational sites. (Protocol was amended where 56 additional patients were recruited and followed for up to 5 years.)

Official Title
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A Clinical Investigation of the SIROlimus Coated Cordis SMART™ Nitinol Selfexpandable Stent for the Treatment of Obstructive Superficial Femoral Artery Disease.

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: drug-eluting stent
* Device: bare-metal stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One superficial femoral artery presenting > 70% stenosis(es) or total occlusion Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3 or 4) Exclusion Criteria: Tissue loss due to ischemic disease (Rutherford category 5 or 6). Tandem lesion requiring non overlapping stents;

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent | Device: drug-eluting stent<br>* Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent<br>|
| Active Comparator: 2<br>SMART™ bare-metal stent | Device: bare-metal stent<br>* SMART™ bare-metal stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent mean lumen diameter percent stenosis via quantitative angiography. |  | 6 months. |