Evaluation of the iCover Stent as a Bridging Stent in Fenestrated Endovascular Aneurysm Repair (f… (NCT07742254) | Clinical Trial Compass
By InvitationNot Applicable
Evaluation of the iCover Stent as a Bridging Stent in Fenestrated Endovascular Aneurysm Repair (fEVAR) for Complex Aortic Aneurysms.
France154 participantsStarted 2026-03-06
Plain-language summary
ReiCo is a French retrospective, multicenter, single-arm study focused on assessing the safety and clinical performance of the iCover balloon-expandable covered stent (iVascular) when implanted as a bridging stent during fEVAR for complex abdominal aortic aneurysms. The aim is to demonstrate conformity by collecting clinical evidence supporting the safe and effective use of this device in fEVAR procedures.
Who can participate
Age range
18 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:
* Underwent a fEVAR procedure between 05/2021 and 12/2024 at one of the participating sites.
* Received at least one iCover stent graft (iVascular, Barcelona, Spain) as a bridging stent during the fEVAR procedure.
* The iCover stent was used to bridge a fenestration in the renal or visceral arteries.
* At least one target vessel is connected with one iCover bridging stent graft (BSG) as standard configuration; use of a second iCover for the same target vessel is acceptable only if relining was required during the procedure
* Only commercially available endografts were used during the fEVAR procedure (excluding physician-modified devices).
* Sites must have a standardized follow-up protocol, ensuring consistent imaging and reporting practices.
* It is recommended to include subjects with follow-up CTA and/or DUS imaging data available for iCover as BSG for a minimum of 1 year from the date of treatment/procedure or until time of death, whichever came first.
* Patients for whom existing medical data are available and who have been informed about the retrospective study via an information letter, without having expressed any objection to the use of their data.
Exclusion Criteria:
* Subjects with ages 18 or below at the time of the procedure.
* Female subjects who may be pregnant or breast-feeding at the time of the procedure.
* Target vessel was previously stented prior to iCover implantation.
* Target vessels with severe (\>50%) pre-stent stenosis or occl…
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.