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| Name | Class |
|---|---|
| Bentley InnoMed GmbH | INDUSTRY |
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The objective of this clinical investigation is to evaluate, in a controlled setting, the safety and performance of the BGP+ balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent in BEVAR (branched endovascular aortic repair) for complex aortic aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGP+ Stent Graft System | Experimental | Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGP+ Stent Graft System as bridging stent | Device | BGP+ Stent Graft System as bridging stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoint (1) - Technical success | defined as successfully introduction and deployment of the BGP+ balloon expandable covered Stent Graft System implanted as bridging stent in BEVAR | 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 - Absence of procedure related complications and bridging stent related endoleaks 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 | defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on Duplex Ultrasound or CT Angio | 1 day post-op, 6- and 24- months post-op |
| Freedom from bridging stent related endoleaks post-procedure |
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Inclusion Criteria:
Patient eligible for elective repair of TAAA with BEVAR in accordance with the applicable guidelines for vascular interventions (e.g. Aneurysm size 6cm or aneurysm growth of >5mm within 6 months or 1cm within 1 year)
Patient is willing to comply with specified follow-up evaluations at the specified times
Patient is >55 years old
Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the trial
• Patient has a projected life-expectancy of at least 12-months
Patient needs to have a landing zone in their target vessel of at least 15 mm, and coverage/ wall adaptation of the BGP+ should be obtained for at least 10 mm.
The access vessel for introduction of the sheath through which the BGP+ will be advanced should be at least 3mm (it should be able to fit a 8F sheath)
No early important division branch from the target vessel with risk of coverage
Absence of pre-existing dissection in the target vessels
Target vessels (renal arteries, superior mesenteric artery, and celiac trunk) for the BGP+ must have a diameter between 5 and 10 mm
Aortic endoprosthesis with inner branches (can be hybrid or branches only)
Hybrid aortic endoprosthesis with fenestrations and branches (at least 2 and only the target vessels which are connected by a branch shall be treated with a study device within this study)
At least one target vessel is bridged with only one BGP+ (relining allowed)
Full compliance with all inclusion criteria/exclusion criteria and all intraoperative criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Austermann, PD. Dr. | Foundation for Cardiovascular Research and Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Dr. med. Dittmar Böckler - Klinik für Gefäßchirurgie und Endovaskuläre Chirurgie | Heidelberg | Baden-Wurttemberg | 69120 | Germany | ||
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| Label | URL |
|---|---|
| First patient recruited into a study to obtain the indication for a bridging stent in BEVAR procedures | View source |
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| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
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Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms
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Freedom from bridging stent related endoleaks post-op, at 6- and 24- months, based on imaging (duplex ultrasound, CT angiography) |
| 1 day post-op, 6- and 24- months post-op |
| Freedom from bridging stent related secondary intervention | Freedom from bridging stent related secondary intervention | 1 day post-op, 6-, 12- and 24- months post-op |
| Freedom from type I & III endoleaks post-procedure post-procedure | Freedom from type I & III 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 |
| 30-day mortality | 30 days post-op |
| Freedom from stent graft migration | 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 post-op implantation, based on imaging (duplex ultrasound or CT Angiography) | 6-, 12- and 24- months post-op |
| Freedom from aneurysm related secondary endovascular procedures | Freedom from aneurysm related secondary endovascular procedures post-op | 1 day post-op, at 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 and at 6, 12 and 24 months | 1 day post-op, 6-, 12-, 24- months post-op |
| Freedom from aneurysm related mortality post-procedure | 1 day post-op, 6-, 12-, 24- months post-op |
| Freedom from aneurysm rupture post-implantation | Freedom from aneurysm rupture within 12- and 24-months post-implantation | up to 12- and 24- months post-op |
| Freedom from any major adverse events post-procedural and at 6 and 12 months | 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 |
| Prof. Dr. Jost Philipp Schäfer Klinik für Radiologie und Neuroradiologie |
| Kiel |
| Schleswig-Holstein |
| 24105 |
| Germany |
| Alexander Gombert | Aachen | Germany |
| University Hospital Eppendorf, UKE Hamburg | Hamburg | Germany |
| University Hospital Leipzig | Leipzig | Germany |
| University Hospital LMU Munich | Munich | Germany |
| St. Franziskus Hospital | Münster | 48145 | Germany |
| Klinikum Nürnberg Süd | Nuremberg | Germany |
| Karin Pfister | Regensburg | Germany |
| Hospital Stuttgart | Stuttgart | Germany |
| D002318 |
| Cardiovascular Diseases |
| D001018 | Aortic Diseases |