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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
103
BGP Stent Graft System as bridging stent
Alexander Gombert
Aachen, Germany
University Heart Center Freiburg- Bad Krozingen
Freiburg im Breisgau, Germany
University Hospital Gießen
Giessen, Germany
University Hospital Hamburg-Eppendorf
Hamburg, Germany
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
Time frame: 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
Time frame: 12 months post-op
Safety endpoint at 12 months
Absence of procedure related complications and bridging stent related endoleaks at 12 months
Time frame: 12 months post-op
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
Time frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from bridging stent related endoleaks post-procedure
Freedom from bridging stent related endoleaks post-op and at 6-, 12- and 24- months, based on imaging (duplex ultrasound, CT angiography)
Time frame: 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
Time frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from type I & III endoleaks post-procedure
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University Hospital LMU Munich
München, Germany
Martin Austermann
Münster, Germany
Klinikum Nürnberg Süd
Nuremberg, Germany
University Hospital Regensburg
Regensburg, Germany
Hospital Stuttgart
Stuttgart, Germany
Freedom from type I \& III endoleaks post procedure and at 6, 12 and 24-months, based on imaging (duplex ultrasound, CT angiography)
Time frame: 1 day post-op, 6-, 12, and 24- months post-op
30-day mortality
Time frame: 30 days post-op
Freedom from stent graft migration post-procedure
defined as freedom from stent graft migration (more than 10 mm)
Time frame: 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)
Time frame: 6-, 12, and 24- months post-op
Freedom from aneurysm related secondary endovascular procedures post-procedure
Freedom from aneurysm related secondary endovascular procedures
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12, and 24- months post-op
Freedom from any major adverse events post-procedure
Freedom from any major adverse events post-procedure
Time frame: 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
Time frame: 12- and 24-months post-op