Arterial Occlusive Diseases Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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