Retrospective Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- JOTEC GmbH
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Freedom from re-intervention of the targeted vessel due to bridging stent complications at 1 year follow-up visit.
研究概览
简要总结
The study aims to check whether the TUVA BX and iCover stent grafts are safe and work well when used during a specific type of minimally invasive surgery (BEVAR) to treat complex aortic aneurysms.
It is a retrospective study and it is conducted at multiple hospitals and does not include a comparison group.
Researchers will collect and review patient data from medical records, starting from the original procedure and continuing through the 1-year follow-up visit.
详细描述
This study looks at how well a medical devices (called TUVA BX / icover stent grafts) has worked in patients who have already been treated for serious problems in the aorta (the body's main blood vessel). These problems include aneurysms, where the wall of the blood vessel becomes weak and bulges.
The device is used during a type of surgery where doctors repair the blood vessel from inside the body using small tubes. These tubes (called stent grafts) help keep the blood vessel open and allow blood to flow normally. The TUVA BX / icover device is used to connect different parts of the repair.
No new treatment or extra hospital visits are needed for this study. Instead, researchers will use information that has already been recorded as part of normal care. This includes details from the original treatment up to the patient's one-year check-up.
The aim is to confirm that these devices are safe and work well in everyday medical practice.
The study will include about 105 patients from up to 25 hospitals across Europe, the UK and Switzerland. It is expected to finish within one year, with final results planned for December 2026.
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
- •Age ≥ 18 years at the time of index procedure
- •Patients must have a completed treatment of TAAA or complex AAA treated with E-nside TAAA Multibranch Stent Graft System (E-nside) or E-xtra Design MultiBranch Stent Graft System (EDM) and with at least one target vessel (CT, SMA, LRA, RRA) bridged with any combination of TUVA BX or iCover.
- •The index procedure was performed after January
- •The patient is not deceased and has already completed or expects to complete the 1 year follow-up visit prior to July 2026; or the patient died.
- •Patients have been consented according to the local regulation.
排除标准
- •Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable before the procedure.
- •Patients enrolled in an investigational study that could confound registry endpoints at index procedure.
- •Patients who developed a new onset of aortic disease (in any segment) since index procedure, potentially having an impact on the performance of the TAAA or TUVA BX /iCover, devices at the discretion of the investigator
研究组 & 干预措施
Device
Patients implanted with the TUVA BX or iCover stent grafts implanted as bridging stent graft in BEVAR (branched endovascular aortic repair) for thoracoabdominal aortic aneurysms (TAAA) and complex abdominal aortic aneurysms (AAA).
干预措施: Endovascular Aortic Repair (Device)
结局指标
主要结局
Freedom from re-intervention of the targeted vessel due to bridging stent complications at 1 year follow-up visit.
时间窗: 1 year
Freedom from re-intervention of the targeted vessel due to bridging stent complications at 1 year follow-up visit.
次要结局
- Technical Success(Perioperative/Periprocedural)
- Patency(1 year)
- Mortality(1 year.)
- Separation of bridging stent graft(1 year)