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| Name | Class |
|---|---|
| FCRE (Foundation for Cardiovascular Research and Education) | OTHER |
| Scitech Produtos Medicos SA | INDUSTRY |
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The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the Solaris Vascular Stent Graft (Scitech) in clinical settings when used according to the indications of the IFU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solaris Vascular Stent Graft | Experimental | Implant of Solaris Vascular Stent Graft in aorto-iliac lesions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solaris Vascular Stent Graft | Device | Solaris Vascular Stent Graft for treatment of Iliac Lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency Rate at 12 month follow-up | 12 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency Rate at 1- and 6 month follow-up | 1 monthand 6 months post-op | |
| Stent Graft Occlusion Rate at pre-discharge, 1-, 6-, and 12-month follow-up | 1day, 1 month, 6 month and 12 month post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Bosiers, MD | Insel Spital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Hochsauerland | Arnsberg | Germany | ||||
| Saarland University Medical Center |
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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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| Ankle-Brachial Index at 1-, 6- and 12-month follow-up compared with baseline ABI | 1-, 6- and 12-month post-op |
| Amputation rate at 1-, 6- and 12-month follow-up, defined as any amputation above the knee | 1-, 6- and 12-month post-op |
| Performance success rate at baseline | defined as a composite of (a) successful in sealing acute perforation or rupture; (b) successful in treating aneurysm and fistulae ; (c) restoration of blood flow | during procedure |
| in-stent restenosis rate at 1-, 6- and 12-month post-op | 1-, 6-, 12-month post-op |
| Freedom from Target Lesion Revascularization at 1-, 6- and 12-month post-op | defined as 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 | 1-, 6- and 12-month post-op |
| Serious Adverse Events (SAE's) until 12-month post-op | within 12-months post-op |
| Technical success rate | defined as the ability to achieve final residual angiographic stenosis no greater than 30% | during procedure |
| Clinical success at follow-up | defined as an improvement of Rutheford Classification at 1-, 6- and 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification | 1-, 6- and 12-month post-op |
| Homburg |
| 66421 |
| Germany |
| University Hospital Leipzig | Leipzig | 04109 | Germany |
| St. Franziskus Hospital | Münster | 48145 | Germany |
| University Hospital Münster | Münster | 48149 | Germany |
| Hospital Oldenburg | Oldenburg | Germany |
| Azienda Ospedaliera di Perugia | Perugia | Italy |
| Fondazione Policlinico Gemelli | Rome | Italy |
| MCL Leeuwarden | Leeuwarden | 8934 | Netherlands |
| St. Antonius Hospital | Nieuwegein | 3435 | Netherlands |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |