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

Objectif(s) de la recherche et intérêt pour la santé publique

Finalité de l'étude

Objectifs poursuivis

Domaines médicaux investigués

Bénéfices attendus

Abdominal aortic aneurysm (AAA) is a progressive vascular disorder. It predominantly affects elderly males and is strongly associated with risk factors such as smoking, hypertension, and atherosclerosis. If left untreated, AAA may rupture, leading to massive haemorrhage and death. Early detection and timely intervention are therefore necessary to prevent this critical risk.
Endovascular aneurysm repair (EVAR) has become the preferred treatment for AAAs, offering reduced perioperative morbidity and mortality compared to open surgical repair. However, standard EVAR is limited by anatomical constraints. Up to 40% of patients present with complex morphologies, which precludes the use of conventional stent grafts.
To address these anatomical challenges, fenestrated Endovascular Aneurysm Repair (fEVAR) was developed. This technique utilizes customized stent grafts with fenestrations aligned to visceral arteries (renal, superior mesenteric, and celiac), which are connected via bridging stent grafts (BSGs). BSGs are essential for maintaining organ perfusion and ensuring a durable seal between the main graft and target vessels without leak into the aneurysmal sac.
This retrospective clinical study aims to gather real-world data on the performance and safety of the iCover stent as BSG in fEVAR. By collecting outcome data from high-volume French centers, the present study will contribute vital clinical and safety information, informing future regulatory and clinical considerations for the iCover stent as BSG in complex AAA repair during fEVAR procedures.

Study Objective:
To retrospectively evaluate the safety and performance of the iVascular iCover stent as a bridging stent in fEVAR for complex abdominal aortic aneurysms.

Study Design:
Multi-center retrospective consecutive data analysis of patients treated with the iCover stent as bridging stent in fEVAR procedures performed between 05/2021 and 12/2024.

Data collection method:
Prior to enrolment into the retrospective clinical study, all patients will be evaluated by their physician to confirm general eligibility criteria. In accordance with French regulations for retrospective studies, patients will be informed about the use of their personal medical data and given the opportunity to object (opposite letter). In the absence of objection, data collection will proceed without the need for written informed consent. For deceased patients, inclusion is only permissible if a representative is listed in the patient file and does not object to participation. In the absence of a listed representative, these patients must be excluded from the study.

As this is a retrospective clinical study involving no additional interventions beyond SOC treatment, no supplementary follow-up or medical care will be required for subjects after their participation concludes. All data are derived from procedures already completed in routine clinical settings, and no contact with subjects is planned. Should any previously undocumented findings arise during retrospective data analysis that merit further clinical attention, the relevant site Principal Investigator will be informed to determine whether notification of the treating physician or responsible clinical team is warranted.

This clinical study does not include vulnerable populations such as children, pregnant or breastfeeding women, or individuals with decisional incapacity. Subjects under 18 years of age, pregnant or breastfeeding at the time of the procedure, or with medical conditions affecting reliable data collection (e.g., severe immunocompromise or incomplete hospital records) are explicitly excluded.