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