BGP+ Stent as Bridging Stent in BEVAR

Study Overview
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Brief Summary
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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.

Official Title
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Physician-Initiated Trial Investigating the BeGraft Peripheral Plus Stent Graft System as Bridging Stent in BEVAR for Complex Aortic Aneurysms

Conditions
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Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture

Intervention / Treatment
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* Device: BGP+ Stent Graft System as bridging stent


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGP+ Stent Graft System<br>Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms | Device: BGP+ Stent Graft System as bridging stent<br>* BGP+ Stent Graft System as bridging stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |