Evaluation of the iCover Stent as a Bridging Stent in Fenestrated Endovascular Aneurysm Repair (fEVAR) for Complex Aortic Aneurysms.

Enrolling by invitation

Conditions studied: Aortic Aneurysm, Aortic Aneurysm Abdominal

In brief

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.

Key facts

Study ID

NCT07742254

Run by

iVascular S.L.U.

People needed

154

Starts

2026-03-06

Expected to finish

2026-08-30

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• CHU de Bordeaux, Chirurgie Vasculaire et Endovasculaire, Hôpital Pellegrin — Bordeaux, France
• CHU Cavale Blanche, clinique en Cardiologie — Brest, France
• ARTER — Marseille, France

Full record on ClinicalTrials.gov

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