Can a new stent keep complex aortic aneurysms safely sealed?
NCT ID NCT07742254
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This study looks at how well the iCover stent works when used as a bridging stent during a procedure called fenestrated endovascular aneurysm repair (fEVAR) for complex abdominal aortic aneurysms. The goal is to see if the stent stays open and keeps the aneurysm sealed without complications for up to a year. Researchers will review data from 154 patients who had this procedure at French hospitals, checking for safety and effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iCover balloon-expandable covered stent
- What this could lead to
- If successful, this could support the safe and effective use of the iCover stent in complex aortic aneurysm repair, potentially improving outcomes for patients who need this procedure.
- What could go wrong
- This is a retrospective study, so it looks back at past procedures rather than testing the device in a controlled way. Results may be limited by the data available and may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 154 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Selection at the primary care clinic
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 occlusion on preoperative imaging where assessment of iCover stent performance was not possible due to lack of adequate post-deployment imaging. * Patients with incomplete data for the in-hospital phase (eg. GFR rate, intraoperative blood loss, fluroscopy time). * Target vessels less than 5 mm in diameter and/or severe vascular diseases (heavy calcification or occlusion, that may compromise device deployment, imaging accuracy or follow up assessment) as assessed by the treating physician. * Patients contraindicated for anti-platelet therapy * Patients with uncontrolled haematological disorders or heparin-induced thrombocytopenia
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ARTER
Marseille, 13007, France
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CHU Cavale Blanche, clinique en Cardiologie
Brest, 29609, France
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CHU de Bordeaux, Chirurgie Vasculaire et Endovasculaire, Hôpital Pellegrin
Bordeaux, 33076, France
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Other studies related to the condition(s) this trial covers.
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