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

Marc Bosiers, MD9 sites in 1 country103 target enrollmentMarch 18, 2021

ConditionsThoracoabdominal Aortic Aneurysm, Without Mention of Rupture Abdominal 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: 103
Locations: 9
Primary Endpoint: Efficacy endpoint (2) ) Bridging stent patency at 12 months
Status: Completed
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 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.

Registry

clinicaltrials.gov

Start Date

March 18, 2021

End Date

August 31, 2024

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 AAA/TAAA extent IV with FEVAR in accordance with the applicable guidelines for vascular interventions (Aneurysm size 5.5cm or aneurysm growth of \>5 mm within 6 months or 1 cm 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 enrollment in the study
•Patient has a projected life-expectancy of at least 12-months
•Indication of elective repair of AAA or TAAA with FEVAR in accordance with the applicable guidelines for vascular interventions
•Patient needs to have a landing zone in their target vessel of at least 10mm
•No early important division branch from the target vessel with risk of coverage
•Absence of dissection
•Target vessels (renal arteries, superior mesenteric artery and celiac trunk) should have a diameter between 5 and 10 mm

Exclusion Criteria

•Previously implanted endograft
•Patients refusing treatment
•Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
•Patients with uncorrected bleeding disorders or heparin induced thrombozytopenia
•Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
•Any planned surgical intervention/procedure within 30 days of the study procedure
•Any patient considered to be hemodynamically unstable at onset of procedure
•Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
•Patients with diffuse distal disease resulting in poor stent outflow
•Fresh thrombus formation

Outcomes

Primary Outcomes

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

Safety endpoint 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

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

Secondary Outcomes

Bridging stent patency post-procedure(1 day post-op, 6-, 12, and 24- months post-op)
30-day mortality(30 days post-op)
Freedom from AAA diameter increase(6-, 12, and 24- months post-op)
Freedom from aneurysm related secondary endovascular procedures post-procedure(1 day post-op, 6-, 12, and 24- months post-op)
Freedom from conversion to open surgical repair post-procedure(1 day post-op, 6-, 12, and 24- months post-op)
Health Related Quality of Life scores(12- and 24-months post-op)
Freedom from bridging stent related endoleaks post-procedure(1 day post-op, 6-, 12, and 24- months post-op)
Freedom from stent graft migration post-procedure(1 day post-op, 6-, 12, and 24- months post-op)
Freedom from bridging stent related secondary intervention post-procedure(1 day post-op, 6-, 12, and 24- months post-op)
Freedom from type I & III endoleaks post-procedure(1 day post-op, 6-, 12, and 24- months post-op)
Freedom from aneurysm related mortality post-procedure(1 day post-op, 6-, 12, and 24- months post-op)
Freedom from aneurysm rupture within 12- and 24-months post-implantation(12, and 24- months post-op)
Freedom from any major adverse events post-procedure(1 day post-op, 6-, 12, and 24- months post-op)