BGP Stent as Bridging Stent in FEVAR

April 7, 2025 updated by: Marc Bosiers, MD

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
BGP Stent Graft System as bridging stent
Other Names:
  • implant of stent graft BGP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 day post-op
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
12 months post-op
Safety endpoint at 12 months
Time Frame: 12 months post-op
Absence of procedure related complications and bridging stent related endoleaks at 12 months
12 months post-op

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bridging stent patency post-procedure
Time Frame: 1 day post-op, 6-, 12, and 24- months post-op
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
1 day post-op, 6-, 12, and 24- months post-op
Freedom from bridging stent related endoleaks post-procedure
Time Frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from bridging stent related endoleaks post-op and at 6-, 12- and 24- months, based on imaging (duplex ultrasound, CT angiography)
1 day post-op, 6-, 12, and 24- months post-op
Freedom from bridging stent related secondary intervention post-procedure
Time Frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from bridging stent related secondary intervention post-op, 6-, 12- and 24- months
1 day post-op, 6-, 12, and 24- months post-op
Freedom from type I & III endoleaks post-procedure
Time Frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from type I & III endoleaks post procedure and at 6, 12 and 24-months, based on imaging (duplex ultrasound, CT angiography)
1 day post-op, 6-, 12, and 24- months post-op
30-day mortality
Time Frame: 30 days post-op
30 days post-op
Freedom from stent graft migration post-procedure
Time Frame: 1 day post-op, 6-, 12, and 24- months post-op
defined as freedom from stent graft migration (more than 10 mm)
1 day post-op, 6-, 12, and 24- months post-op
Freedom from AAA diameter increase
Time Frame: 6-, 12, and 24- months post-op
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)
6-, 12, and 24- months post-op
Freedom from aneurysm related secondary endovascular procedures post-procedure
Time Frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from aneurysm related secondary endovascular procedures
1 day post-op, 6-, 12, and 24- months post-op
Freedom from conversion to open surgical repair post-procedure
Time Frame: 1 day post-op, 6-, 12, and 24- months post-op
Freedom from conversion to open surgical repair post-op
1 day post-op, 6-, 12, and 24- months post-op
Freedom from aneurysm related mortality post-procedure
Time Frame: 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
Time Frame: 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
Time Frame: 1 day post-op, 6-, 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
Health Related Quality of Life scores
Time Frame: 12- and 24-months post-op
Health Related Quality of Life scores at 12- and 24-months post implantation
12- and 24-months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marc Bosiers, MD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric Verhoeven, Prof. Dr., Foundation for Cardiovascular Research and Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 19, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FCRE-200504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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