BGP+ Stent as Bridging Stent in BEVAR

NCT03982940 | Active Not Recruiting DMC

• 1 other identifier: FCRE-190129
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 10

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.

Conditions

Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Bridging stent patency post-procedure

  1 day post-op, 6- and 24- months 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 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

Study Arms (1)

BGP+ Stent Graft System

EXPERIMENTAL

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

Interventions

BGP+ Stent Graft System as bridging stent DEVICE

BGP+ Stent Graft System as bridging stent

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 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Marc Bosiers, MD: lead
• Bentley InnoMed GmbH: collaborator

Study Sites (10)

Prof. Dr. med. Dittmar Böckler - Klinik für Gefäßchirurgie und Endovaskuläre Chirurgie

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Prof. Dr. Jost Philipp Schäfer Klinik für Radiologie und Neuroradiologie

Kiel, Schleswig-Holstein, 24105, Germany

Location

Alexander Gombert

Aachen, Germany

Location

University Hospital Eppendorf, UKE Hamburg

Hamburg, Germany

Location

University Hospital Leipzig

Leipzig, Germany

Location

University Hospital LMU Munich

Munich, Germany

Location

St. Franziskus Hospital

Münster, 48145, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, Germany

Location

Karin Pfister

Regensburg, Germany

Location

Hospital Stuttgart

Stuttgart, Germany

Location

Related Links

• First patient recruited into a study to obtain the indication for a bridging stent in BEVAR procedures

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Martin Austermann, PD. 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 Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 12, 2019
• Study Start: September 9, 2020
• Primary Completion: March 8, 2023
• Study Completion: July 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (10)