Status:
COMPLETED
The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent
Lead Sponsor:
Cordis US Corp.
Conditions:
Arterial Occlusive Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C \& D superficial femoral artery long lesions (up to 22 cm) in comparison wi...
Detailed Description
This is a German multi-center prospective, randomized, two-arm study evaluating performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System as compared to the C.R. Bard® Luminexx™ 6F Vascular...
Eligibility Criteria
Inclusion
- Symptomatic leg ischemia by Rutherford classification (category 2, 3, 4 or 5); duration of intermittent claudication (category 2-3) should be at least 3 months.
- One superficial femoral artery de novo or restenotic lesion (more than 70% stenosis or occlusions), with a lesion length of more than 5 to less than 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.
Exclusion
- Revascularisation involving the same limb within 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure.
- Patients having total occlusions of the iliac artery on the same side must be excluded.
- Previously implanted stent(s) in the to be treated artery at the same site.
- Requiring stent placement in the distal superficial femoral artery and the popliteal artery.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00235131
Start Date
May 1 2005
End Date
May 1 2009
Last Update
February 4 2010
Active Locations (2)
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1
Gemeinschaftspraxis füsar Radiologische Diagnostik& Zentrum für Minimal Invasite Therapie am Jüdischen Krankenhaus Berlin
Berlin, Germany, 13347
2
Universitat Leipzig Herzzentrum Abt. Für Klinische u. Intervent. Angiologie
Leipzig, Germany, 04289