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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| Ziekenhuis Oost-Limburg | OTHER |
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This is a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions. Target number is 500 patients in approximately 11 centres. Patients will be followed for a period of 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rutherford category 2 - 5 |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary patency | Primary patency rate at 12 and 24 months as determined by Duplex ultrasound, defined as <50% diameter restenosis(systolic velocity ratio no greater than 2.4) at the level of the treated lesion, without occurrence of target lesion revasularization between the index-procedure and the 12 and 24 months follow-up. | 12, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary patency | Patency as defined by absence of >50% restenosis , whether or not after additional intervention to maintain this patency | 12 and 24 months |
| Target lesion revascularization | Target lesion revascularisation rate as defined by the number of new revascularizations (endovascular or surgery) carried out due to restenosis or thrombosis at the level of the stented lesion |
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Inclusion Criteria:
Exclusion Criteria:
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Stenosis (> 75%) or occlusion of the superficial femoral artery.
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| Name | Affiliation | Role |
|---|---|---|
| Sabrina Houthoofd, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Herman Schroë, MD | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost Limburg | Genk | Limburg | 3600 | Belgium | ||
| University Hospital Leuven |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| 12 and 24 months |
| Target vessel revascularization | Target vessel revascularization rate as defined by the number of new revascularizations (endovascular or surgery) carried out due to restenosis or a new stenosis in the SFA | 12 and 24 months |
| Limb-salvage rate | 12 and 24 months |
| Clinical success rate | Clinical success rate defined asimprovement in symptoms according to the Rutherford classification by a minimum of 1 class. | 12 and 24 months |
| Leuven |
| Vlaams Brabant |
| 3000 |
| Belgium |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |