The Study to Treat Superficial Femoral Artery Occlusions.

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to assess the performance of the Cordis SMART™ nitinol self-expandable stent for the treatment of superficial femoral artery (SFA) occlusions in comparison with balloon angioplasty only as determined by binary restenosis at one year.

Detailed Description
-----------------
This is a multi-center, prospective, randomized, two-arm study evaluating the performance of the Cordis SMART™ nitinol self-expanding stent as compared to angioplasty only. It is anticipated that a total of 150 patients will be entered into the study. Patients will be randomized on a 1:1 basis of stent versus angioplasty only. 150 patients with de novo or restenotic native SFA occlusions (5-22 cm) with reference vessel of >= 4.0 to <= 6.0 mm in diameter will be randomized to the SMART™ nitinol self-expanding stent or to angioplasty only. All patients will be followed for 12 months post-procedure, by telephone contact at 3 and 6 months, and a 12 month clinical and duplex ultrasound assessment. This study will be conducted at up to 12 investigational sites.

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

Conditions
-----------------
Arterial Occlusive Diseases

Intervention / Treatment
-----------------
* Device: stent
* Device: angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One superficial femoral artery de novo or restenotic lesion (> 70% stenosis or occlusions), with a lesion length > 5 to < 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. Additional intervention to further improve blood flow to the lower limb is acceptable during the index procedure, but after successful treatment of the study lesions Exclusion Criteria: Revascularisation involving the same limb within 7 days prior to the index procedure or a planned revascularisation within 7 days after the index procedure Patient having total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow is allowed during the same procedure and prior to the treatment of the study lesion. Patients enrolled in this or other clinical trial or anticipated to be included into a trial, without written approval of the Cordis medical monitor and the principal investigator of this study.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 self-expanding stent. | Device: stent<br>* Cordis SMART™ nitinol self-expanding stent.<br>* Other names: Cordis SMART™ nitinol self-expanding stent;|
| Active Comparator: 2<br>balloon angioplasty | Device: angioplasty<br>* balloon angioplasty<br>* Other names: balloon angioplasty;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary restenosis as demonstrated by Duplex Ultrasound. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success. |  | at time of deployment | 
| Procedural success: defined as successful recanalization, without the occurrence of a SAE event. |  | up to the moment the catheter sheath introducer has been removed | 
| Ankle Brachial Index |  | at discharge and 12 months | 
| Restenosis measured by Duplex Ultrasound |  | at discharge and 12 months | 

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