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.
This retrospective clinical study evaluates the safety and performance of the iCover stent graft when used as a bridging stent in fenestrated endovascular aortic repair (fEVAR) for complex aortic aneurysms. In fEVAR procedures, bridging stents are essential for connecting fenestrations in the aortic endograft to visceral target vessels, maintaining visceral perfusion and ensuring aneurysmal sac exclusion preventing risk of rupture and death. The study aims to gather real-world data on iCover's clinical outcomes in this routine application, potentially supporting future conformity assessment for its extended use in fEVAR. Early studies suggest that iCover has a strong technical success, durability, and target vessel stability when repurposed as a bridging stent. Up to date, three physician-initiated studies have assessed iCover´s performance as a bridging stent in fEVAR procedures, providing important early evidence of its performance and safety. Although 4 dedicated and approved devices for this indication have become available in the past year, variability in anatomical and procedural requirements continues to drive the evaluation of alternative technologies. This study aims to contribute important safety and performance data to inform future clinical and regulatory considerations for the iCover device in this specific indication.
Study Type
OBSERVATIONAL
Enrollment
154
CHU de Bordeaux, Chirurgie Vasculaire et Endovasculaire, Hôpital Pellegrin
Bordeaux, France
CHU Cavale Blanche, clinique en Cardiologie
Brest, France
ARTER
Marseille, France
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.
Time frame: 12 months
Technical success rate
Technical success rate: defined as successful introduction, deployment and appropriate positioning of the iCover bridging stent in all intended target vessels without immediate Type I or III endoleaks or conversion to open repair.
Time frame: Periprocedural
Patency
iCover bridging stent patency post-procedure and at 6-months follow-up (if available retrospectively).
Time frame: From Day 1 to ≤3 months after the index procedure, and at 6 months follow-up
Endoleaks
Freedom from iCover bridging stent related endoleaks post-procedure, at 6- (if available retrospectively), and 12- months follow-up
Time frame: 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)
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