- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03987035
BGP Stent as Bridging Stent in FEVAR
November 7, 2023 updated by: Dr. Sabrina Overhagen
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
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Phase 3
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
-
-
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Aachen, Germany
- Alexander Gombert
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Freiburg, Germany, 79106
- University Heart Center Freiburg- Bad Krozingen
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Gießen, Germany
- University Hospital Gießen
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Hamburg, Germany, 20246
- University Hospital Hamburg-Eppendorf
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München, Germany
- University Hospital LMU Munich
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Münster, Germany, 48145
- Martin Austermann
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Nürnberg, Germany
- Klinikum Nürnberg Süd
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Regensburg, Germany
- University Hospital Regensburg
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Stuttgart, Germany
- Hospital Stuttgart
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-
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
Ages Eligible for Study
53 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 |
Intervention / Treatment |
---|---|
Experimental: BGP Stent Graft System
BGP Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms
|
BGP Stent Graft System as bridging stent
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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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
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
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Freedom from type I & III endoleaks post procedure and at 6, 12 and 24-months, based on imaging (duplex ultrasound, CT angiography)
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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
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defined as freedom from stent graft migration (more than 10 mm)
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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
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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)
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6-, 12, and 24- months post-op
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Freedom from aneurysm related secondary endovascular procedures post-procedure
Time Frame: 1 day post-op, 6-, 12, and 24- months post-op
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Freedom from aneurysm related secondary endovascular procedures
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1 day post-op, 6-, 12, and 24- months post-op
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Freedom from conversion to open surgical repair post-procedure
Time Frame: 1 day post-op, 6-, 12, and 24- months post-op
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Freedom from conversion to open surgical repair post-op
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1 day post-op, 6-, 12, and 24- months post-op
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Freedom from aneurysm related mortality post-procedure
Time Frame: 1 day post-op, 6-, 12, and 24- months post-op
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Freedom from aneurysm related mortality post-procedure
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1 day post-op, 6-, 12, and 24- months post-op
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Freedom from aneurysm rupture within 12- and 24-months post-implantation
Time Frame: 12, and 24- months post-op
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Freedom from aneurysm rupture within 12- and 24-months post-implantation
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12, and 24- months post-op
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Freedom from any major adverse events post-procedure
Time Frame: 1 day post-op, 6-, 12, and 24- months post-op
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Freedom from any major adverse events post-procedure
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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
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Health Related Quality of Life scores at 12- and 24-months post implantation
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12- and 24-months post-op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Verhoeven, Prof. Dr., Foundation for Cardiovascular Research and Education
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)
March 18, 2021
Primary Completion (Actual)
July 19, 2022
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
June 12, 2019
First Submitted That Met QC Criteria
June 13, 2019
First Posted (Actual)
June 14, 2019
Study Record Updates
Last Update Posted (Actual)
November 8, 2023
Last Update Submitted That Met QC Criteria
November 7, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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