Evaluation of the iCover Stent as a Bridging Stent in Fenestrated Endovascular Aneurysm Repair (fEVAR) for Complex Aortic Aneurysms.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 154
- 试验地点
- 3
- 主要终点
- Primary performance endpoint; Primary safety endpoint
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Primary performance endpoint; Primary safety endpoint
时间窗: 12 months
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.
次要结局
- 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))