Arterial Occlusive Diseases Clinical Trial
Official title:
A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty Only for the Treatment of SUPERficial Femoral Artery Occlusions
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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