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临床试验/NCT07399392
NCT07399392招募中不适用

Radial Versus Femoral Secondary Access in Patients Undergoing TAVI

University Heart Center Freiburg - Bad Krozingen1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
Vascular and bleeding complications related to the secondary vascular access site

研究概览

简要总结

Severe symptomatic aortic stenosis (AS) with a high gradient is associated with a poor prognosis if not treated with valve replacement. Transcatheter aortic valve implantation has been shown in large randomized trials to be a safe and effective treatment option for patients at low, intermediate, or high risk. Transfemoral access for heart valve replacement is by far the most commonly used approach, as it is relatively easy to control and has a low complication rate compared to other access routes.

The TAVI procedure requires two arterial access points: one with a large lumen for the TAVI prosthesis via the femoral artery, and a smaller second one for a pigtail catheter that guides the TAVI prosthesis into the optimal position. This secondary access is most often via a second artery.

Vascular complications are the most commonly observed complications in transfemoral TAVI and are associated with poorer procedural outcomes.

Recent data suggest that secondary vascular access via the radial artery may contribute to a reduction in vascular complications after TAVI. In patients undergoing coronary angiography and/or percutaneous coronary intervention, radial access has become the preferred strategy due to its proven reduction in vascular complications compared to femoral access. The use of radial access is associated with a lower incidence of vascular complications compared to femoral access.

Recent non-randomized data suggest that radial access may be a safer alternative to traditional femoral access as a secondary arterial access in transfemoral TAVI. However, non-randomized retrospective comparisons are subject to selection bias and underreporting of complications. Therefore, a prospective randomized trial is needed to evaluate the value of radial access for secondary arterial access in patients undergoing transfemoral TAVI.

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

入选标准

  • Patients scheduled for transfemoral TAVI
  • Heart team agrees on eligibility of TAVI
  • Written informed consent
  • Age > 18 years

排除标准

  • Non accessible radial arteries as judged by the TAVI team
  • Non accessible femoral arteries as judged by the TAVI team
  • Foreseeable problems to achieve primary transfemoral access (hostile access)
  • Hemodynamic instability or cardiogenic shock
  • Currently participating in an investigational drug or another device study
  • Lack of capability to give informed consent
  • Patient refuses TAVI

研究组 & 干预措施

Group 1 Radial

Active Comparator

Group 1: patients with radial secondary arterial access

干预措施: Radial TAVI (Procedure)

Group 2 femoral

Active Comparator

Group 2: patients with femoral secondary arterial access

干预措施: femoral TAVI (Procedure)

结局指标

主要结局

Vascular and bleeding complications related to the secondary vascular access site

时间窗: 30 days

次要结局

  • Until 30 days after index procedure:(30 days)

研究者

发起方
University Heart Center Freiburg - Bad Krozingen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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