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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
118
BGP+ Stent Graft System as bridging stent
Prof. Dr. med. Dittmar Böckler - Klinik für Gefäßchirurgie und Endovaskuläre Chirurgie
Heidelberg, Baden-Wurttemberg, Germany
Prof. Dr. Jost Philipp Schäfer Klinik für Radiologie und Neuroradiologie
Kiel, Schleswig-Holstein, Germany
Alexander Gombert
Aachen, Germany
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
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 - 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
Time frame: 12 months post-op
Bridging stent patency post-procedure
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- and 24- months post-op
Freedom from bridging stent related endoleaks post-procedure
Freedom from bridging stent related endoleaks post-op, at 6- and 24- months, based on imaging (duplex ultrasound, CT angiography)
Time frame: 1 day post-op, 6- and 24- months post-op
Freedom from bridging stent related secondary intervention
Freedom from bridging stent related secondary intervention
Time frame: 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)
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University Hospital Eppendorf, UKE Hamburg
Hamburg, Germany
University Hospital Leipzig
Leipzig, Germany
University Hospital LMU Munich
Munich, Germany
St. Franziskus Hospital
Münster, Germany
Klinikum Nürnberg Süd
Nuremberg, Germany
Karin Pfister
Regensburg, Germany
Hospital Stuttgart
Stuttgart, Germany
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
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 post-op 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
Freedom from aneurysm related secondary endovascular procedures post-op
Time frame: 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
Time frame: 1 day post-op, 6-, 12-, 24- months post-op
Freedom from aneurysm related mortality post-procedure
Time frame: 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
Time frame: up to 12- and 24- months post-op
Freedom from any major adverse events post-procedural and at 6 and 12 months
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