The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The lesion is located within the native CFA and treated with predillation prior to stenting with the Supera Peripheral Stent System. Patients will be invited for a follow-up visit at 1, 6, 12 and 24 month post procedure. The primary endpoint of the study is the primary patency at 12 months and periprocedural events up to 30 days post procedure. Secondary endpoints include technical success, primary patency rate at 1, 6 and 24 month, freedom from TLR at 1-, 6-, 12 and 24 month follow-up and clinical success at 1-, 6-, 12- and 24-month follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
ZNA Stuivenberg
Antwerp, Antwerp, Belgium
OLV Ziekenhuis Aalst
Aalst, Oost-Vlaanderen, Belgium
AZ Sint-Blasius
Dendermonde, Oost-Vlaanderen, Belgium
Imelda Hospital
Bonheiden, Belgium
Clinique Rhone Durance
Avignon, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CHU de Nantes
Nantes, France
Primary patency at 12 months
freedom from \> 50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) \<2.5 in the target vessel with no reintervention (TLR) within 12 months.
Time frame: 12 months
Periprocedural adverse events
periprocedural adverse events up to 30 days post procedure, as defined per ISO 14155:2011
Time frame: 30 days post procedure
Technical success
ability to cross and stent the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging.
Time frame: during indexprocedure
Primary patency rate at 1, 6 and 24 month
freedom from \>50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) \<2.5 in the target vessel with no intervention within 1 and 6 months.
Time frame: 1, 6 and 24 month post procedure
Freedom from TLR until 24 month post procedure
freedom from a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge at the respective time points
Time frame: until 24 month post procedure
Clinical success
an improvement of Rutherford classification at 1-, 6-, 12- and 24-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Time frame: 1, 6, 12 and 24 month follow-up
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