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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supera Peripheral Stent System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supera Peripheral Stent System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Periprocedural adverse events | periprocedural adverse events up to 30 days post procedure, as defined per ISO 14155:2011 | 30 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during indexprocedure |
| Primary patency rate at 1, 6 and 24 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koen Deloose, MD | ID3 Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Stuivenberg | Antwerp | Antwerp | 2060 | Belgium | ||
| OLV Ziekenhuis Aalst |
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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.
| 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 | 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. | 1, 6, 12 and 24 month follow-up |
| Aalst |
| Oost-Vlaanderen |
| 9300 |
| Belgium |
| AZ Sint-Blasius | Dendermonde | Oost-Vlaanderen | 9200 | Belgium |
| Imelda Hospital | Bonheiden | 2820 | Belgium |
| Clinique Rhone Durance | Avignon | 84000 | France |
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| CHU de Nantes | Nantes | 44093 | France |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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