Thoracoabdominal Aortic Aneurysm, Without Mention of RuptureNCT03987035
BGP Stent as Bridging Stent in FEVAR
A study testing BeGraft Peripheral (BGP) Stent Graft System as bridging stent in people with Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture and Abdominal Aortic Aneurysm, Without Mention of Rupture, run by Marc Bosiers, MD at 9 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, Abdominal Aortic Aneurysm, Without Mention of Rupture
- What is being tested?
- BeGraft Peripheral (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
- 103 participants
- Where
- 9 sitesGermany
- Study dates
- 18 Mar 2021to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Alexander Gombert
Aachen
University Heart Center Freiburg- Bad Krozingen
Freiburg im Breisgau, 79106
University Hospital Gießen
Giessen
University Hospital Hamburg-Eppendorf
Hamburg, 20246
University Hospital LMU Munich
München
Martin Austermann
Münster, 48145
Klinikum Nürnberg Süd
Nuremberg
University Hospital Regensburg
Regensburg
Hospital Stuttgart
Stuttgart
About this study
Official title: 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.
- Conditions
- Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, Abdominal Aortic Aneurysm, Without Mention of Rupture
- Being tested
- BeGraft Peripheral (BGP) Stent Graft System as bridging stent
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeGraft Peripheral (BGP) Stent Graft System as bridging stentDevice
Also called implant of stent graft BGP
BGP Stent Graft System as bridging stent
| Study group | Role | What they receive |
|---|---|---|
| BGP Stent Graft System | Experimental | BGP Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms Receives: Device: BeGraft Peripheral (BGP) Stent Graft System as bridging stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months post-op
Safety endpoint at 12 months
Absence of procedure related complications and bridging stent related endoleaks at 12 months
Measured: 12 months post-op
Secondary outcomes (13)
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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 1 day post-op, 6-, 12, and 24- months post-op
30-day mortality
Measured: 30 days post-op
Freedom from stent graft migration post-procedure
defined as freedom from stent graft migration (more than 10 mm)
Measured: 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)
Measured: 6-, 12, and 24- months post-op
Freedom from aneurysm related secondary endovascular procedures post-procedure
Freedom from aneurysm related secondary endovascular procedures
Measured: 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
Measured: 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
Measured: 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
Measured: 12, and 24- months post-op
Freedom from any major adverse events post-procedure
Freedom from any major adverse events post-procedure
Measured: 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
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.
- First posted14 Jun 2019
- Study start18 Mar 2021
- Primary completion19 Jul 2022
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal Aortic Aneurysm, Without Mention of RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marc Bosiers, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marc Bosiers, MD, FCRE (Foundation for Cardiovascular Research and Education)
- Investigators
- Eric Verhoeven, Prof. Dr., Principal investigator, Foundation for Cardiovascular Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987035
- Sponsor's protocol ID
- FCRE-200504
- Status last verified
- Apr 2025
- First submitted
- 12 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System as Bridging Stent in FEVAR for Complex Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT03987035
- Acronym / sponsor ID
- FCRE-200504
- Conditions
- Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, Abdominal Aortic Aneurysm, Without Mention of Rupture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Marc Bosiers, MDUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Application of BeGraft Peripheral Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms
| Arm | Type | Receives |
|---|---|---|
| BGP Stent Graft System | Experimental | Device: BeGraft Peripheral (BGP) Stent Graft System as bridging stentBGP Stent Graft System as bridging stent in Fenestrated Endovascular Repair (FEVAR) for complex aortic aneurysms |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeGraft Peripheral (BGP) Stent Graft System as bridging stentAlso: implant of stent graft BGPBGP Stent Graft System as bridging stent | Device | BGP Stent Graft System |
Primary outcome
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
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
Safety endpoint at 12 months
Time frame: 12 months post-op
Absence of procedure related complications and bridging stent related endoleaks at 12 months
13 secondary outcomes
Bridging stent patency post-procedure
Time frame: 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 secondary intervention post-procedure
Time frame: 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
30-day mortality
Time frame: 30 days post-op
Freedom from stent graft migration post-procedure
Time frame: 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
Freedom from aneurysm related secondary endovascular procedures post-procedure
Time frame: 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 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
Time frame: 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
Health Related Quality of Life scores
Time frame: 12- and 24-months post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Bentley announces FEVAR indication for BeGraft and launch of new BeFlared fenestrated bridging stent - Vascular NewsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Verhoeven, Prof. Dr. principal investigator
Foundation for Cardiovascular Research and Education
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BeGraft Peripheral (BGP) Stent Graft System as bridging stent in people with Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture and Abdominal Aortic Aneurysm, Without Mention of Rupture, run by Marc Bosiers, MD at 9 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 13 inclusion and 22 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: finished, 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 9 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.