Status:
COMPLETED
The Study to Compare SMART Nitinol Stent and Balloon Angioplasty
Lead Sponsor:
Cordis US Corp.
Conditions:
Superficial Femoral Artery Occlusions
Eligibility:
All Genders
30+ years
Phase:
PHASE4
Brief Summary
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 bas...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 3 months;
- One de-novo or restenotic SFA with an occluded length \> 5 to \< 22 cm;
- Patent popliteal artery on the index side (without \> 50% stenotic (re) stenotic lesions) and at least single vessel infrapopliteal runoff (without \> 50% stenotic (re) stenotic lesions). However, balloon angioplasty to further improve the blood flow is allowed at the index procedure.
Exclusion
- Revascularization involving the same limb 30 days prior to the index procedure or a planned revascularization within 30 days after the index procedure;
- Patients having severe stenoses or total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow during the index procedure (prior to the treatment of the target lesion) is allowed;
- Requiring stent placement in the popliteal artery. For the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00309595
Start Date
December 1 2005
End Date
May 1 2009
Last Update
June 12 2009
Active Locations (2)
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1
Univeristy Hospital Bern
Bern, Switzerland, CH-3010
2
University Hospital Zurich
Zurich, Switzerland, CH-8091