Superficial Femoral Artery Occlusions Clinical Trial
Official title:
A Multi-Center Prospective, Randomized, Two-Arm Clinical Investigation of the Cordis SMARTTM Nitinol Self Expandable Stent Versus Balloon Angioplasty Only for the Treatment of Superficial Femoral Artery Occlusions.
This is a multi-center prospective, randomized, two-arm study evaluating performance of the
Cordis SMART™ Nitinol Stent System compared to balloon angioplasty. Patients will be
randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered
into the study.
Objective of the study is: Performance of the Cordis S.M.A.R.T.™ (CONTROL™) Nitinol Stent
System for the treatment of superficial femoral artery (SFA) long de novo or restenotic
lesions (≥ 70% stenosis or occlusions) in comparison with balloon angioplasty as determined
by Binary Restenosis (≥50% restenosis based on a peak systolic velocity ratio ≥ 2.5) at one
year as demonstrated by Duplex sonography.
The study population will consist of 120 symptomatic peripheral vascular disease patients
with SFA occlusions. The disease will consist of symptomatic, de novo or restenotic
occlusions (5 - 22 cm) on diagnostic imaging. 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. At least one calf vessel must be patent. Reference
vessel diameter must be >= 4.0 to <= 6.0 mm.
Trial participants who meet all entry criteria, will be randomized to the SMART™ Nitinol
Stent or balloon angioplasty.
Patients will be followed for 12 months after the procedure. Study examinations will be done
at screening, procedure time, discharge, 1, 6 and 12 months after the study procedure.
This study will be conducted as an investigator initiated multicenter study with 6 study
centers in Switzerland. Principal investigators will be Prof. Amann, PD Dr. med T.
Pfammatter (University Hospital Zürich) and Prof. I. Baumgartner, Prof. J. Triller
(University Hospital Bern).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment