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Completed
NCT03941314
A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease
Conditions: Peripheral Arterial Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: Kantonsspital Winterthur KSW
Location: Hospital Carlos Haya Málaga
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Patients with femoro-popliteal artery disease, who will require a stent femoro-popliteal following failed percutaneous transluminal angioplasty (PTA)
* Target Lesion length \
Source: ClinicalTrials.gov (NCT03941314). StuddyBuddy aggregates publicly available trial information.
