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The objective of this clinical investigation is to evaluate, in a controlled setting, the safety and performance of the BeGraft Peripheral (BGP) balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent in FEVAR (fenestrated endovascular aortic repair) for complex aortic aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGP Stent Graft System | Experimental | BGP Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BeGraft Peripheral (BGP) Stent Graft System as bridging stent | Device | BGP Stent Graft System as bridging stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoint (1) - Technical success | Successful introduction and deployment of the BeGraft Peripheral (BGP) balloon expandable covered stent Graft System (Bentley Innomed, Hechingen, Germany) implanted as bridging stent in FEVAR | 1 day post-op |
| Efficacy endpoint (2) ) Bridging stent patency at 12 months | defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on CT Angio at 12 months | 12 months post-op |
| Safety endpoint at 12 months | Absence of procedure related complications and bridging stent related endoleaks at 12 months | 12 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Bridging stent patency post-procedure | Bridging stent patency post-op and at 6-, 12- and 24-months, defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on Duplex ultrasound or CT Angio | 1 day post-op, 6-, 12, and 24- months post-op |
| Freedom from bridging stent related endoleaks post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Verhoeven, Prof. Dr. | Foundation for Cardiovascular Research and Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexander Gombert | Aachen | Germany | ||||
| University Heart Center Freiburg- Bad Krozingen |
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| Label | URL |
|---|---|
| Bentley announces FEVAR indication for BeGraft and launch of new BeFlared fenestrated bridging stent - Vascular News | View source |
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| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Application of BeGraft Peripheral Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms
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Freedom from bridging stent related endoleaks post-op and at 6-, 12- and 24- months, based on imaging (duplex ultrasound, CT angiography) |
| 1 day post-op, 6-, 12, and 24- months post-op |
| Freedom from bridging stent related secondary intervention post-procedure | Freedom from bridging stent related secondary intervention post-op, 6-, 12- and 24- months | 1 day post-op, 6-, 12, and 24- months post-op |
| Freedom from type I & III endoleaks post-procedure | Freedom from type I & III endoleaks post procedure and at 6, 12 and 24-months, based on imaging (duplex ultrasound, CT angiography) | 1 day post-op, 6-, 12, and 24- months post-op |
| 30-day mortality | 30 days post-op |
| Freedom from stent graft migration post-procedure | defined as freedom from stent graft migration (more than 10 mm) | 1 day post-op, 6-, 12, and 24- months post-op |
| Freedom from AAA diameter increase | defined as more than 5mm increase in maximum diameter measured at 6- , 12- and 24- months as compared to postop-implantation, based on imaging (duplex ultrasound or CT Angiography) | 6-, 12, and 24- months post-op |
| Freedom from aneurysm related secondary endovascular procedures post-procedure | Freedom from aneurysm related secondary endovascular procedures | 1 day post-op, 6-, 12, and 24- months post-op |
| Freedom from conversion to open surgical repair post-procedure | Freedom from conversion to open surgical repair post-op | 1 day post-op, 6-, 12, and 24- months post-op |
| Freedom from aneurysm related mortality post-procedure | Freedom from aneurysm related mortality post-procedure | 1 day post-op, 6-, 12, and 24- months post-op |
| Freedom from aneurysm rupture within 12- and 24-months post-implantation | Freedom from aneurysm rupture within 12- and 24-months post-implantation | 12, and 24- months post-op |
| Freedom from any major adverse events post-procedure | Freedom from any major adverse events post-procedure | 1 day post-op, 6-, 12, and 24- months post-op |
| Health Related Quality of Life scores | Health Related Quality of Life scores at 12- and 24-months post implantation | 12- and 24-months post-op |
| Freiburg im Breisgau |
| 79106 |
| Germany |
| University Hospital Gießen | Giessen | Germany |
| University Hospital Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| University Hospital LMU Munich | München | Germany |
| Martin Austermann | Münster | 48145 | Germany |
| Klinikum Nürnberg Süd | Nuremberg | Germany |
| University Hospital Regensburg | Regensburg | Germany |
| Hospital Stuttgart | Stuttgart | Germany |
| D001018 |
| Aortic Diseases |