The purpose of this study (superiority trial) is to compare the Supera® Peripheral Stent System with a standard nitinol self-expanding stent for treatment of femoro-popliteal arterial occlusive disease. Hypothesis: The Supera® stent is superior to a standard nitinol self-expanding stent, for treatment of femoro-popliteal artery disease in terms of (1) primary patency rate and (2) need for revascularization up to 24 months after stent insertion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.
The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.
Hospital Carlos Haya
Málaga, Spain
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland
Difference in primary patency rate (proportion of patients classed as treatment succsess)
Peak systolic velocity ratio assessed with Duplex ultrasound (Treatment success is defined as Peak Systolic Velocity (PSV) ratio \< 2.5 at the stented target lesion measured by Duplex ultrasound (DUS) indicating freedom from \>50% restenosis with no clinically driven re-intervention within the stented segment.)
Time frame: 24 months
Difference in primary patency rate
Peak systolic velocity ratio assessed with Duplex ultrasound
Time frame: 1 month, 6 months, 12 months
Difference in target lesion/vessel revascularization
Patients with target lesion revascularization due to restenosis or target vessel revascularization.
Time frame: 24 months
Difference in amputation
Proportion of patients with amputation (minor or major)
Time frame: 24 months
Difference in time to restenosis (and time to target lesion revascularization due to restenosis)
Time frame: 24 months
Difference in Anklre Brachial Index
Ankle Brachial Index of the treated lesion
Time frame: 1 month, 6 months, 12 months, 24 months
Difference in Fontaine classification
Fontaine classification
Time frame: 1 month, 6 months, 12 months, 24 months
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