Status:
TERMINATED
The Study to Compare the Treatment of Angioplasty and Stents in SFA Occlusions.
Lead Sponsor:
Cordis US Corp.
Conditions:
Arterial Occlusive Diseases
Eligibility:
All Genders
30+ years
Phase:
PHASE4
Brief Summary
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 on...
Detailed Description
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 randomi...
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 6 months
- The patient should be suitable for percutaneous transluminal angioplasty (PTA) and also for stenting.
Exclusion
- Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft.
- Patient having total occlusions or severe stenosis of the iliac artery on the same side must be excluded.
- Gangrene in index limb (Rutherford category 6).
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00289055
Start Date
November 1 2005
End Date
June 1 2008
Last Update
February 24 2009
Active Locations (1)
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1
AMC
Amsterdam, Netherlands, 1105 AZ