BGP Stent as Bridging Stent in FEVAR

NCT03987035 | Completed DMC

• 1 other identifier: FCRE-200504
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 9

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

Outcome Measures

Primary Outcomes (3)

• Efficacy endpoint (1) - Technical success

  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

  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 at 12 months

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

  12 months post-op

Secondary Outcomes (13)

• Bridging stent patency post-procedure

  1 day post-op, 6-, 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 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

• 30-day mortality

  30 days post-op

Study Arms (1)

BGP Stent Graft System

EXPERIMENTAL

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

Device: BeGraft Peripheral (BGP) Stent Graft System as bridging stent

Interventions

BeGraft Peripheral (BGP) Stent Graft System as bridging stent DEVICE

BGP Stent Graft System as bridging stent

Also known as: implant of stent graft BGP

BGP Stent Graft System

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Marc Bosiers, MD: lead

Study Sites (9)

Alexander Gombert

Aachen, Germany

Location

University Heart Center Freiburg- Bad Krozingen

Freiburg im Breisgau, 79106, Germany

Location

University Hospital Gießen

Giessen, Germany

Location

University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

University Hospital LMU Munich

München, Germany

Location

Martin Austermann

Münster, 48145, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, Germany

Location

University Hospital Regensburg

Regensburg, Germany

Location

Hospital Stuttgart

Stuttgart, Germany

Location

Related Links

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

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Eric Verhoeven, Prof. Dr.

  Foundation for Cardiovascular Research and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: Application of BeGraft Peripheral Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 14, 2019
• Study Start: March 18, 2021
• Primary Completion: July 19, 2022
• Study Completion: August 31, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (9)