CompletedNCT03987035Updated Apr 9, 2025

BGP Stent as Bridging Stent in FEVAR

An interventional study of BeGraft Peripheral (BGP) Stent Graft System as bridging stent in Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture and Abdominal Aortic Aneurysm, Without Mention of Rupture, sponsored by Marc Bosiers, MD. Completed at 9 sites in Germany. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Marc Bosiers, MD · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 103
Allocation: Not applicable
Ages: 55 Years and older
Sex: All

Study 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 studied

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

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In context

Aneurysm

959 studies on the registry are indexed under Aneurysm; 174 are open to participants now.

This study's enrollment of 103 is above the median of 72 across 462 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Marc Bosiers, MD is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 55 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 103 participants (actual)

Study arms

Experimental
BGP Stent Graft System
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

DeviceBeGraft Peripheral (BGP) Stent Graft System as bridging stent
BGP Stent Graft System as bridging stent
Also known as: implant of stent graft BGP

What researchers measure

Primary outcomes

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
Time frame: 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
Time frame: 12 months post-op
Safety endpoint at 12 months
Absence of procedure related complications and bridging stent related endoleaks at 12 months
Time frame: 12 months post-op

Secondary outcomes

Bridging stent patency post-procedure
Bridging stent patency post-op and at 6-, 12- and 24-months, defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on Duplex ultrasound or CT Angio
Time frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from bridging stent related endoleaks post-procedure
Freedom from bridging stent related endoleaks post-op and at 6-, 12- and 24- months, based on imaging (duplex ultrasound, CT angiography)
Time frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from bridging stent related secondary intervention post-procedure
Freedom from bridging stent related secondary intervention post-op, 6-, 12- and 24- months
Time frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from type I & III endoleaks post-procedure
Freedom from type I \& III endoleaks post procedure and at 6, 12 and 24-months, based on imaging (duplex ultrasound, CT angiography)
Time frame: 1 day post-op, 6-, 12, and 24- months post-op
30-day mortality
Time frame: 30 days post-op
Freedom from stent graft migration post-procedure
defined as freedom from stent graft migration (more than 10 mm)
Time frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from AAA diameter increase
defined as more than 5mm increase in maximum diameter measured at 6- , 12- and 24- months as compared to postop-implantation, based on imaging (duplex ultrasound or CT Angiography)
Time frame: 6-, 12, and 24- months post-op
Freedom from aneurysm related secondary endovascular procedures post-procedure
Freedom from aneurysm related secondary endovascular procedures
Time frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from conversion to open surgical repair post-procedure
Freedom from conversion to open surgical repair post-op
Time frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from aneurysm related mortality post-procedure
Freedom from aneurysm related mortality post-procedure
Time frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from aneurysm rupture within 12- and 24-months post-implantation
Freedom from aneurysm rupture within 12- and 24-months post-implantation
Time frame: 12, and 24- months post-op
Freedom from any major adverse events post-procedure
Freedom from any major adverse events post-procedure
Time frame: 1 day post-op, 6-, 12, and 24- months post-op
Health Related Quality of Life scores
Health Related Quality of Life scores at 12- and 24-months post implantation
Time frame: 12- and 24-months post-op

Study locations

9 sites

Alexander Gombert
Aachen, Germany
University Heart Center Freiburg- Bad Krozingen
Freiburg, 79106, Germany
University Hospital Gießen
Gießen, Germany
University Hospital Hamburg-Eppendorf
Hamburg, 20246, Germany
University Hospital LMU Munich
München, Germany
Martin Austermann
Münster, 48145, Germany
Klinikum Nürnberg Süd
Nürnberg, Germany
University Hospital Regensburg
Regensburg, Germany
Hospital Stuttgart
Stuttgart, Germany

References and documents

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03987035
Lead sponsor: Marc Bosiers, MD
Responsible party: Marc Bosiers, MD (Director, FCRE (Foundation for Cardiovascular Research and Education)) — Sponsor-investigator
First posted: Jun 14, 2019
Start date: Mar 18, 2021
Primary completion: Jul 19, 2022
Completion: Aug 31, 2024
Last update: Apr 9, 2025

Study contacts

Eric Verhoeven, Prof. Dr.

principal investigator · Foundation for Cardiovascular Research and Education

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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