BGP Stent as Bridging Stent in FEVAR (NCT03987035) | Clinical Trial Compass
CompletedNot Applicable
BGP Stent as Bridging Stent in FEVAR
Germany103 participantsStarted 2021-03-18
Plain-language 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 aortic aneurysms.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 antiplatel…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy endpoint (1) - Technical success
Timeframe: 1 day post-op
2
Efficacy endpoint (2) ) Bridging stent patency at 12 months