Status:
COMPLETED
A Study of the SMART Stent in the Treatment SFA Disease.
Lead Sponsor:
Cordis US Corp.
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
The main objective of this study is to assess the safety and performance of the sirolimus coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the treatment of obstruct...
Detailed Description
This is a multi-center, prospective, randomized, double blind, two-arm feasibility study evaluating the safety and performance of the sirolimus coated Cordis SMART™ nitinol self-expanding stent and de...
Eligibility Criteria
Inclusion
- One superficial femoral artery presenting \> 70% stenosis(es) or total occlusion
- Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3 or 4)
Exclusion
- Tissue loss due to ischemic disease (Rutherford category 5 or 6).
- Tandem lesion requiring non overlapping stents;
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00232869
Start Date
February 1 2001
End Date
May 1 2009
Last Update
February 4 2010
Active Locations (1)
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1
University Hospital
Tübingen, Germany, 72070