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Thoracoabdominal Aortic Aneurysm, Without Mention of RuptureNCT03982940

BGP+ Stent as Bridging Stent in BEVAR

A study testing BGP+ Stent Graft System as bridging stent in people with Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, run by Marc Bosiers, MD at 10 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
BGP+ Stent Graft System as bridging stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
10 sitesGermany
Study dates
9 Sep 2020to 31 Jul 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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)
  • Full compliance with all inclusion criteria/exclusion criteria and all intraoperative criteria

Who cannot join

  • 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
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  • 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
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • Alexander Gombert

    Aachen

  • University Hospital Eppendorf, UKE Hamburg

    Hamburg

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

    Heidelberg, Baden-Wurttemberg, 69120

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

    Kiel, Schleswig-Holstein, 24105

  • University Hospital Leipzig

    Leipzig

  • University Hospital LMU Munich

    Munich

  • St. Franziskus Hospital

    Münster, 48145

  • Klinikum Nürnberg Süd

    Nuremberg

  • Karin Pfister

    Regensburg

  • Hospital Stuttgart

    Stuttgart

Other trials in Germany

About this study

Official title: 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.

Being tested
BGP+ Stent Graft System as bridging stent
Medical subject headings
Aortic Aneurysm, Thoracoabdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGP+ Stent Graft System as bridging stentDevice

    BGP+ Stent Graft System as bridging stent

Study groups in NCT03982940
Study groupRoleWhat they receive
BGP+ Stent Graft SystemExperimentalApplication of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms
Receives: Device: BGP+ Stent Graft System as bridging stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 day post-op

  2. 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

    Measured: 12 months post-op

  3. 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

    Measured: 12 months post-op

Secondary outcomes (13)

  1. Bridging stent patency post-procedure

    defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on Duplex Ultrasound or CT Angio

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

  2. Freedom from bridging stent related endoleaks post-procedure

    Freedom from bridging stent related endoleaks post-op, at 6- and 24- months, based on imaging (duplex ultrasound, CT angiography)

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

  3. Freedom from bridging stent related secondary intervention

    Freedom from bridging stent related secondary intervention

    Measured: 1 day post-op, 6-, 12- and 24- months post-op

  4. Freedom from type I & III endoleaks post-procedure post-procedure

    Freedom from type I \& III endoleaks post-op and at 6-, 12- and 24- months, based on imaging (duplex ultrasound, CT angiography)

    Measured: 1 day post-op, 6-, 12-, and 24- months post-op

  5. 30-day mortality

    Measured: 30 days post-op

  6. Freedom from stent graft migration

    defined as freedom from stent graft migration (more than 10 mm)

    Measured: 1 day post-op, 6-, 12 -and 24- months post-op

  7. Freedom from AAA diameter increase

    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)

    Measured: 6-, 12- and 24- months post-op

  8. Freedom from aneurysm related secondary endovascular procedures

    Freedom from aneurysm related secondary endovascular procedures post-op

    Measured: 1 day post-op, at 6-, 12- and 24- months post-op

  9. Freedom from conversion to open surgical repair post-procedure

    Freedom from conversion to open surgical repair post-op and at 6, 12 and 24 months

    Measured: 1 day post-op, 6-, 12-, 24- months post-op

  10. Freedom from aneurysm related mortality post-procedure

    Measured: 1 day post-op, 6-, 12-, 24- months post-op

  11. Freedom from aneurysm rupture post-implantation

    Freedom from aneurysm rupture within 12- and 24-months post-implantation

    Measured: up to 12- and 24- months post-op

  12. Freedom from any major adverse events post-procedural and at 6 and 12 months

    Measured: 1 day post-op, 6-, 12- and 24- months post-op

  13. Health Related Quality of Life scores

    Health Related Quality of Life scores at 12- and 24 months post implantation

    Measured: 12- and 24- months post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2019
  2. Study start9 Sep 2020
  3. Primary completion8 Mar 2023
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Application of BeGraft Peripheral Plus (BGP+) Stent Graft System as bridging stent in Branched Endovascular Repair (BEVAR) for complex aortic aneurysms
Masking
None (open label)
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03982940
Sponsor's protocol ID
FCRE-190129
Status last verified
Apr 2025
First submitted
6 Jun 2019
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BGP+ Stent Graft System as bridging stent in people with Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, run by Marc Bosiers, MD at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy endpoint (1) - Technical success (time frame: 1 day post-op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03982940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.

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