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

NCT07742254 | Enrolling By Invitation

• 2 other identifiers: RO-20250710N° 27753917
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Aortic Aneurysm; Aortic Aneurysm Abdominal

Keywords

endovascular aneurysm repair; fEVAR; Bridging stent graft

Outcome Measures

Primary Outcomes (1)

• Primary performance endpoint; Primary safety endpoint

  iCover bridging stent patency at 12 months, defined as the proportion of iCover stents showing an absence of binary restenosis (≥ 50% stenosis) based on computed tomography angiography (CTA) and/or duplex ultrasound (DUS). Absence of iCover-related target vessel instability up to 12 months, defined as the rate of patient with an absence of target vessel instability described as a composite endpoint of any branch-related complication leading to: Aneurysm rupture/ death/ occlusion/ component separation/ or reintervention to maintain branch patency or to treat a branch-related component separation or endoleak between implantation and 12 months visit.

  12 months

Secondary Outcomes (3)

• Technical success rate

  Periprocedural

• Patency

  From Day 1 to ≤3 months after the index procedure, and at 6 months follow-up

• Endoleaks

  From Day 1 to ≤3 months after the index procedure, at 6- (if available retrospectively, >3 to ≤9 months), and 12- months follow-up (>9 to ≤18 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Selection at the primary care clinic

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

Sponsors & Collaborators

• iVascular S.L.U.: lead

Study Sites (3)

CHU de Bordeaux, Chirurgie Vasculaire et Endovasculaire, Hôpital Pellegrin

Bordeaux, 33076, France

Location

CHU Cavale Blanche, clinique en Cardiologie

Brest, 29609, France

Location

ARTER

Marseille, 13007, France

Location

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Sara Pich, phD

  iVascular

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: August 3, 2026
• Study Start: March 6, 2026
• Primary Completion: July 31, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)