BGP Stent as Bridging Stent in FEVAR

NCT ID: NCT03987035

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-18
• Study Completion Date: 2024-08-31

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.

Conditions

Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture; Abdominal Aortic Aneurysm, Without Mention of Rupture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BGP Stent Graft System

BGP Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms

Group Type: EXPERIMENTAL

BeGraft Peripheral (BGP) Stent Graft System as bridging stent

Intervention Type: DEVICE

BGP Stent Graft System as bridging stent

Interventions

BeGraft Peripheral (BGP) Stent Graft System as bridging stent

BGP Stent Graft System as bridging stent

Intervention Type: DEVICE

Other Intervention Names

implant of stent graft BGP

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
• Patient eligible for fenestrated endovascular repair as per IFU of the fenestrated endograft
• Angulation of the aorta at the level of the target vessels <45 degrees
• The fenestrated endograft has to be constructed so the fenestrations lie in front of the orifice of the target vessel, and the gap between the fenestration and the orifice of the target vessel should not exceed 10mm.

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
• Stenosed (>50%) or occluded target vessel
• Angulation between renal artery and aortic wall <30 degrees
• Patients with known hypersensitivity to the stent material (L605) and/or PTFE
• Hybrid Approach
• 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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marc Bosiers, MD

OTHER

Sponsor Role: lead

Responsible Party

Marc Bosiers, MD

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eric Verhoeven, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Foundation for Cardiovascular Research and Education

Locations

Alexander Gombert

Aachen, , Germany

University Heart Center Freiburg- Bad Krozingen

Freiburg im Breisgau, , Germany

University Hospital Gießen

Giessen, , Germany

University Hospital Hamburg-Eppendorf

Hamburg, , Germany

University Hospital LMU Munich

München, , Germany

Martin Austermann

Münster, , Germany

Klinikum Nürnberg Süd

Nuremberg, , Germany

University Hospital Regensburg

Regensburg, , Germany

Hospital Stuttgart

Stuttgart, , Germany

Countries

Germany

Related Links

https://vascularnews.com/bentley-announces-fevar-indication-for-begraft-and-launch-of-new-beflared-fenestrated-bridging-stent/

Bentley announces FEVAR indication for BeGraft and launch of new BeFlared fenestrated bridging stent - Vascular News

Other Identifiers

FCRE-200504

Identifier Type: -

Identifier Source: org_study_id