NCT03811119已完成不适用
MANTA™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
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
- 151
- 试验地点
- 1
- 主要终点
- Composite rate of major- and minor vascular complications according to VARC-2
研究概览
简要总结
To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to suture-based VCDs in preventing vascular access site complications in patients undergoing transfemoral transcatheter aortic valve replacement.
详细描述
see summary
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 undergoing elective transfemoral TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV)
- •Common femoral artery diameter > 5.0mm (14 - 22F compatible)
排除标准
- •Symptomatic leg ischaemia
- •Previous thromboendarterectomy or plastic patch of the common femoral artery
- •Previous implantation of a suture-based VCD less than 30 days before, or a plug-based VCD within 6 months
- •Unilateral or bilateral lower extremity amputation
- •Systemic infection or a local infection at or near the access site
- •Allergy to the components any of both devices (i.e. bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel)
- •Active bleeding or bleeding diathesis including thrombocytopenia (platelet count <50,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
- •Patients in whom continuous oral anticoagulation therapy cannot be stopped for the peri-procedural period or patients with INR >1.8 at the time of the procedure
- •Patient unable to be adequately anti-coagulated for the procedure
- •Morbidly obese or cachectic (BMI >40 kg/m2 or <20 kg/m2)
- •Anatomical and procedural contraindication for suture-based or Manta closure (lack of proper puncture site in the common femoral artery in terms of calcification, size, and atherosclerotic disease)
- •Absence of computed tomographic data of the access site before the procedure
- •Patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease
- •Known pregnancy at time of randomization (in women of childbearing potential a negative pregnancy test is mandatory)
- •Participating in trials in which the primary endpoint includes bleeding or vascular complications
研究组 & 干预措施
MANTA vascular closure device
Active Comparator
Arteriotomy closure with a collagen-based vascular closure device (MANTA™)
干预措施: MANTA vascular closure device (Device)
Suture based vascular closure device
Active Comparator
Arteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide)
干预措施: Suture based vascular closure device (Device)
结局指标
主要结局
Composite rate of major- and minor vascular complications according to VARC-2
时间窗: Between transcatheter aortic valve implantation and 30 days follow-up
The primary endpoint will consist of the composite of major- and minor vascular complications according to the Valve Academic Research Consortium (VARC)-2 at 30 days follow-up.
次要结局
- Length of hospital stay(Up to a maximum of 30 days after the TAVI procedure)
- Number of Participants with a Major Vascular Complication according to VARC-2(Between transcatheter aortic valve implantation and 30 days follow-up)
- Number of Participants with a Minor Vascular Complication according to VARC-2(Between transcatheter aortic valve implantation and 30 days follow-up)
- Time to hemostasis(During the TAVI procedure)
- All-cause death rate(Between transcatheter aortic valve implantation and 30 days follow-up)
- Number of Participants with a major- or life threatening bleeding according to VARC-2(Between transcatheter aortic valve implantation and 30 days follow-up)
- Need for transfusions for access site related bleeding/complications(Between transcatheter aortic valve implantation and 30 days follow-up)
- Number of Participants with vascular closure device failure(Between transcatheter aortic valve implantation and 30 days follow-up)
- Total procedure time(During the TAVI procedure)
- Number of Participants with a clinically relevant bleeding defined as BARC 2, 3 and 5(Between transcatheter aortic valve implantation and 30 days follow-up)
研究者
Nicolas van Mieghem
Principal Investigator
Erasmus Medical Center
研究点 (1)
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