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

Marc Bosiers, MD10 sites in 1 country118 target enrollmentSeptember 9, 2020

ConditionsThoracoabdominal Aortic Aneurysm, Without Mention of Rupture

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture
Sponsor: Marc Bosiers, MD
Enrollment: 118
Locations: 10
Primary Endpoint: Safety endpoint - Absence of procedure related complications and bridging stent related endoleaks at 12 months
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 9, 2020

End Date

July 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Marc Bosiers, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Marc Bosiers, MD

Director

FCRE (Foundation for Cardiovascular Research and Education)

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Safety endpoint - Absence of procedure related complications and bridging stent related endoleaks at 12 months

Time Frame: 12 months post-op

Absence of procedure related complications and bridging stent related endoleaks at 12 months

Efficacy endpoint (1) - Technical success

Time Frame: 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

Time Frame: 12 months post-op

defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on CT angio at 12 months

Secondary Outcomes

Bridging stent patency post-procedure(1 day post-op, 6- and 24- months post-op)
Freedom from type I & III endoleaks post-procedure post-procedure(1 day post-op, 6-, 12-, and 24- months post-op)
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 secondary intervention(1 day post-op, 6-, 12- and 24- months post-op)
Freedom from stent graft migration(1 day post-op, 6-, 12 -and 24- months post-op)
Freedom from AAA diameter increase(6-, 12- and 24- months post-op)
Freedom from aneurysm related secondary endovascular procedures(1 day post-op, at 6-, 12- and 24- months 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)
Freedom from conversion to open surgical repair post-procedure(1 day post-op, 6-, 12-, 24- months post-op)
Freedom from aneurysm rupture 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)