NCT04459208已完成不适用
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 516
- 试验地点
- 1
- 主要终点
- Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
研究概览
简要总结
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.
详细描述
Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with an indication for transfemoral TAVI as judged by the local heart team.
- •Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team.
- •The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations.
排除标准
- •Vascular access site anatomy not suitable for percutaneous vascular closure.
- •Vascular access site complications prior to the TAVI procedure.
- •Known allergy or hypersensitivity to any VCD component.
- •Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia.
- •Absence of computed tomographic data of the access site before the procedure.
- •Systemic infection or a local infection at or near the access site.
- •Life expectancy of less than 6 months due to non-cardiac conditions.
- •Patient cannot adhere to or complete the investigational protocol for any reason.
- •Pregnant or nursing subjects.
- •Participation in any other interventional trial.
研究组 & 干预措施
Manta
Active Comparator
plug-based vascular closure
干预措施: Manta (Device)
ProGlide
Active Comparator
suture-based vascular closure
干预措施: ProGlide (Device)
结局指标
主要结局
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
时间窗: up to 7 days
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
次要结局
- Rate of minor access site or access-related vascular injury(up to 7 days and at 30 days)
- Rate of access-site or access-related vascular injury(30 days)
- Rate of major access-site or access-related vascular injury(up to 7 days and at 30 days)
- death attributed to access-site or access-related complications(up to 7 days and 30-day)
- Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site(up to 7 days)
- access-site or access-related disabling/life- threatening bleeding according to BARC(up to 7 days and 30-day)
- all-cause death(up to 7 days and 30-day)
- access-site or access-related minor bleeding according to BARC(up to 7 days and 30-day)
- Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis(24 hours)
- Percent diameter stenosis of vascular access vessel on post-procedural angiography(24 hours)
- Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria(up to 7 days and at 30 days))
- access-site or access-related major bleeding according to BARC(up to 7 days and 30-day)
- Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment(24 hours)
- Time to hemostasis, defined as the time from VCD application to complete hemostasis(24 hours)
- Total number of blood transfusions because of access-site or access-related bleeding(up to 7 days)
- Length of postprocedural hospital stay(up to 7 days)
- Need and number of additional unplanned VCDs(24 hours)
- Need for blood transfusion for access-site or access-related bleeding or vascular complications(up to 7 days)
研究者
研究点 (1)
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