BGP+ Stent as Bridging Stent in BEVAR

April 7, 2025 updated by: Marc Bosiers, MD

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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 (Estimated)

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.
118

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Sabrina Overhagen
  • Phone Number: +4915785319015
  • Email: info@fcre.eu

Study Locations

  • Germany
      • Aachen, Germany
        • Alexander Gombert
      • Hamburg, Germany
        • University Hospital Eppendorf, UKE Hamburg
      • Leipzig, Germany
        • University Hospital Leipzig
      • Munich, Germany
        • University Hospital LMU Munich
      • Münster, Germany, 48145
        • St. Franziskus Hospital
      • Nürnberg, Germany
        • Klinikum Nurnberg Sud
      • Regensburg, Germany
        • Karin Pfister
      • Stuttgart, Germany
        • Hospital Stuttgart
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Prof. Dr. Jost Philipp Schäfer Klinik für Radiologie und Neuroradiologie
    • bW
      • Heidelberg, bW, Germany, 69120
        • Prof. Dr. med. Dittmar Böckler - Klinik für Gefäßchirurgie und Endovaskuläre Chirurgie

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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)
  2. Patient is willing to comply with specified follow-up evaluations at the specified times
  3. Patient is >55 years old

  4. 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

  5. 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.
  6. 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)
  7. No early important division branch from the target vessel with risk of coverage
  8. Absence of pre-existing dissection in the target vessels
  9. Target vessels (renal arteries, superior mesenteric artery, and celiac trunk) for the BGP+ must have a diameter between 5 and 10 mm
  10. Aortic endoprosthesis with inner branches (can be hybrid or branches only)
  11. 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)
  12. At least one target vessel is bridged with only one BGP+ (relining allowed)
  13. Full compliance with all inclusion criteria/exclusion criteria and all intraoperative criteria

Exclusion Criteria:

  1. Previously implanted stent in the target vessel
  2. Renal artery with >100° cranial orientation
  3. Patients refusing treatment
  4. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
  5. Patients with uncorrected bleeding disorders or heparin induced thrombocytopenia
  6. Female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding
  7. Any planned surgical intervention/procedure within 30 days of the trial procedure
  8. Patients with rupture or any patient considered to be hemodynamically unstable at onset of procedure
  9. Patient is currently participating in another conflicting investigational drug or device trial that has not completed the entire follow up period.
  10. Patients with diffuse distal disease resulting in poor stent outflow
  11. Fresh thrombus formation within the last 14 days
  12. Patients with known hypersensitivity to the stent material (L605) and/or PTFE
  13. Hybrid Approach (endovascular in combination with open surgery)
  14. Patients with a connective tissue disorder
  15. Patients with mycotic or inflammatory aneurysm
  16. Myocardial infarction or stroke within 3 months prior to the procedure
  17. Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4
  18. Patients with ASA classification 5 or higher
  19. Contraindications against contrast enhanced angiography (a.e. massive hyperthyroidism)
  20. Patients with increased risk of intraoperative rupture
  21. 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
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
BGP+ Stent Graft System as bridging stent

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
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
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 - Absence of procedure related complications and bridging stent related endoleaks 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
30-day mortality
Time Frame: 30 days post-op
30 days post-op
Bridging stent patency post-procedure
Time Frame: 1 day post-op, 6- and 24- months post-op
defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on Duplex Ultrasound or CT Angio
1 day post-op, 6- and 24- months post-op
Freedom from bridging stent related endoleaks post-procedure
Time Frame: 1 day post-op, 6- and 24- months post-op
Freedom from bridging stent related endoleaks post-op, at 6- and 24- months, based on imaging (duplex ultrasound, CT angiography)
1 day post-op, 6- and 24- months post-op
Freedom from bridging stent related secondary intervention
Time Frame: 1 day post-op, 6-, 12- 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
Time Frame: 1 day post-op, 6-, 12-, and 24- months post-op
Freedom from type I & III 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 stent graft migration
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 post-op implantation, based on imaging (duplex ultrasound or CT Angiography)
6-, 12- and 24- months post-op
Freedom from aneurysm related secondary endovascular procedures
Time Frame: 1 day post-op, at 6-, 12- and 24- months post-op
Freedom from aneurysm related secondary endovascular procedures post-op
1 day post-op, at 6-, 12- and 24- months post-op
Freedom from conversion to open surgical repair post-procedure
Time Frame: 1 day post-op, 6-, 12-, 24- months post-op
Freedom from conversion to open surgical repair post-op and at 6, 12 and 24 months
1 day post-op, 6-, 12-, 24- months post-op
Freedom from aneurysm related mortality post-procedure
Time Frame: 1 day post-op, 6-, 12-, 24- months post-op
1 day post-op, 6-, 12-, 24- months post-op
Freedom from aneurysm rupture post-implantation
Time Frame: up to 12- and 24- months post-op
Freedom from aneurysm rupture within 12- and 24-months post-implantation
up to 12- and 24- months post-op
Freedom from any major adverse events post-procedural and at 6 and 12 months
Time Frame: 1 day post-op, 6-, 12- and 24- months post-op
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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bentley InnoMed GmbH

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: Martin Austermann, PD. 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.
September 9, 2020

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.
March 8, 2023

Study Completion (Estimated)

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.
July 31, 2025

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 6, 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 11, 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 12, 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-190129

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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