Status:
COMPLETED
The Study to Treat Superficial Femoral Artery 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 performance of the Cordis SMART™ nitinol self-expandable stent for the treatment of superficial femoral artery (SFA) occlusions in comparison with bal...
Detailed Description
This is a multi-center, prospective, randomized, two-arm study evaluating the performance of the Cordis SMART™ nitinol self-expanding stent as compared to angioplasty only. It is anticipated that a t...
Eligibility Criteria
Inclusion
- One superficial femoral artery de novo or restenotic lesion (\> 70% stenosis or occlusions), with a lesion length \> 5 to \< 22 cm.
- Patent popliteal artery on the index side, i.e., single vessel runoff or better with at least one of three vessels patent to the lower 1/3 of the calf prior to the day of the procedure. Additional intervention to further improve blood flow to the lower limb is acceptable during the index procedure, but after successful treatment of the study lesions
Exclusion
- Revascularisation involving the same limb within 7 days prior to the index procedure or a planned revascularisation within 7 days after the index procedure Patient having total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow is allowed during the same procedure and prior to the treatment of the study lesion.
- Patients enrolled in this or other clinical trial or anticipated to be included into a trial, without written approval of the Cordis medical monitor and the principal investigator of this study.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00232843
Start Date
March 1 2005
End Date
May 1 2009
Last Update
June 3 2009
Active Locations (2)
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1
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
2
University Hospital of North Staffordshire
Newcastle-under-Lyme, United Kingdom, ST4 6QG