BGP+ Stent as Bridging Stent in BEVAR
- Conditions
- Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture
- Interventions
- Device: BGP+ Stent Graft System as bridging stent
- Registration Number
- NCT03982940
- Lead Sponsor
- Marc Bosiers, MD
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 118
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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)
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Patient is willing to comply with specified follow-up evaluations at the specified times
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Patient is >55 years old
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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
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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.
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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)
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No early important division branch from the target vessel with risk of coverage
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Absence of pre-existing dissection in the target vessels
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Target vessels (renal arteries, superior mesenteric artery, and celiac trunk) for the BGP+ must have a diameter between 5 and 10 mm
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Aortic endoprosthesis with inner branches (can be hybrid or branches only)
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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)
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At least one target vessel is bridged with only one BGP+ (relining allowed)
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Full compliance with all inclusion criteria/exclusion criteria and all intraoperative criteria
- Previously implanted stent in the target vessel
- Renal artery with >100° cranial orientation
- Patients refusing treatment
- Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- Patients with uncorrected bleeding disorders or heparin induced thrombocytopenia
- Female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding
- Any planned surgical intervention/procedure within 30 days of the trial procedure
- Patients with rupture or any patient considered to be hemodynamically unstable at onset of procedure
- Patient is currently participating in another conflicting investigational drug or device trial that has not completed the entire follow up period.
- Patients with diffuse distal disease resulting in poor stent outflow
- Fresh thrombus formation within the last 14 days
- Patients with known hypersensitivity to the stent material (L605) and/or PTFE
- Hybrid Approach (endovascular in combination with open surgery)
- Patients with a connective tissue disorder
- Patients with mycotic or inflammatory aneurysm
- Myocardial infarction or stroke within 3 months prior to the procedure
- Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4
- Patients with ASA classification 5 or higher
- Contraindications against contrast enhanced angiography (a.e. massive hyperthyroidism)
- Patients with increased risk of intraoperative rupture
- Patients with access vessel which are too tortuous, narrow or any kind of reason that would lead to failure of introducing and advancing an introducer sheath
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BGP+ Stent Graft System BGP+ Stent Graft System as bridging stent Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms
- Primary Outcome Measures
Name Time Method Safety endpoint - Absence of procedure related complications and bridging stent related endoleaks at 12 months 12 months post-op Absence of procedure related complications and bridging stent related endoleaks at 12 months
Efficacy endpoint (1) - Technical success 1 day post-op defined as successfully introduction and deployment of the BGP+ balloon expandable covered Stent Graft System implanted as bridging stent in BEVAR
Efficacy endpoint (2) - Bridging stent patency at 12 months 12 months post-op defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on CT angio at 12 months
- Secondary Outcome Measures
Name Time Method Bridging stent patency post-procedure 1 day post-op, 6- and 24- months post-op defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on Duplex Ultrasound or CT Angio
Freedom from type I & III endoleaks post-procedure post-procedure 1 day post-op, 6-, 12-, and 24- months post-op Freedom from type I \& III endoleaks post-op and at 6-, 12- and 24- months, based on imaging (duplex ultrasound, CT angiography)
30-day mortality 30 days post-op Freedom from bridging stent related endoleaks post-procedure 1 day post-op, 6- and 24- months post-op Freedom from bridging stent related endoleaks post-op, at 6- and 24- months, based on imaging (duplex ultrasound, CT angiography)
Freedom from bridging stent related secondary intervention 1 day post-op, 6-, 12- and 24- months post-op Freedom from bridging stent related secondary intervention
Freedom from stent graft migration 1 day post-op, 6-, 12 -and 24- months post-op defined as freedom from stent graft migration (more than 10 mm)
Freedom from AAA diameter increase 6-, 12- and 24- months post-op 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)
Freedom from aneurysm related secondary endovascular procedures 1 day post-op, at 6-, 12- and 24- months post-op Freedom from aneurysm related secondary endovascular procedures post-op
Freedom from aneurysm related mortality post-procedure 1 day post-op, 6-, 12-, 24- months post-op Health Related Quality of Life scores 12- and 24- months post-op Health Related Quality of Life scores at 12- and 24 months post implantation
Freedom from conversion to open surgical repair post-procedure 1 day post-op, 6-, 12-, 24- months post-op Freedom from conversion to open surgical repair post-op and at 6, 12 and 24 months
Freedom from aneurysm rupture post-implantation up to 12- and 24- months post-op Freedom from aneurysm rupture within 12- and 24-months post-implantation
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
Trial Locations
- Locations (10)
University Hospital Leipzig
🇩🇪Leipzig, Germany
St. Franziskus Hospital
🇩🇪Münster, Germany
Klinikum Nürnberg Süd
🇩🇪Nürnberg, Germany
Karin Pfister
🇩🇪Regensburg, Germany
Hospital Stuttgart
🇩🇪Stuttgart, Germany
Prof. Dr. med. Dittmar Böckler - Klinik für Gefäßchirurgie und Endovaskuläre Chirurgie
🇩🇪Heidelberg, bW, Germany
Alexander Gombert
🇩🇪Aachen, Germany
University Hospital Eppendorf, UKE Hamburg
🇩🇪Hamburg, Germany
Prof. Dr. Jost Philipp Schäfer Klinik für Radiologie und Neuroradiologie
🇩🇪Kiel, Schleswig-Holstein, Germany
University Hospital LMU Munich
🇩🇪Munich, Germany