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临床试验/NCT06284837
NCT06284837已完成不适用

Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?

The Alfred3 个研究点 分布在 1 个国家目标入组 542 人开始时间: 2024年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
542
试验地点
3
主要终点
All clinically relevant bleeding and all vascular complications

研究概览

简要总结

Transcatheter aortic valve implantation (TAVI) is a well-known safe and effective treatment for anatomically suitable patients with severe aortic stenosis (AS). Despite rapid improvements in TAVI technique and technology, vascular and bleeding complications from both primary and secondary access sites remain significant, with approximately 25% of access related complications thought to be related to secondary access. The transfemoral route remains the most common approach for primary access during TAVI due to proven safety and efficacy. Secondary access during TAVI, which is needed for angiographic guidance, has drawn little attention in randomised trials of TAVI. In coronary intervention, the radial approach is now preferred due to high quality evidence suggesting lower bleeding and vascular complications compared to the femoral approach. Whilst randomised control trials comparing radial vs femoral as secondary access are lacking in the TAVI setting, observational studies comparing the two secondary access routes have shown a lower risk of bleeding and vascular complications with radial compared to femoral access. A systematic review of all the major observational trials also suggests that radial access might reduce risk of bleeding, vascular complications, and even 30-day mortality, but these data are limited to observational trials and there are no randomised controlled data to confirm these findings. Accordingly, we aim to undertake a multicentre, randomised controlled trial among patients undergoing transfemoral TAVI to assess if radial secondary access is superior to femoral secondary access.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • •Age >18 years
  • •Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
  • •Suitable radial and secondary femoral access

排除标准

  • •Primary arterial access via surgical cut-down
  • •Inadequate contralateral femoral artery access and/or bilateral radial artery access as determined by the interventional cardiologist
  • •Previously failed attempt to access bilateral radial arteries.
  • •Patient on hemodialysis

研究组 & 干预措施

Radial secondary access

Active Comparator

干预措施: Access site (Other)

Femoral secondary access

Active Comparator

干预措施: Access site (Other)

结局指标

主要结局

All clinically relevant bleeding and all vascular complications

时间窗: 30 days

The composite of all clinically relevant bleeding (defined as Bleeding Academic Research Consortium \[BARC\] type ≥2) and vascular complications (Valve Academic Research Consortium \[VARC3\] criteria) at 30 days.

次要结局

  • Conversion rate to alternative vascular access site(30 days)
  • Tertiary site utilised to treat vascular complication(30 days)
  • Failure to perform angiogram of primary access site at completion of TAVI(1 day)
  • Major adverse cardiovascular events(30 days)
  • All-cause death(30 days)
  • Stroke(30 days)
  • Myocardial infarction(30 days)
  • Length of stay post-procedure(30 days)
  • Overall procedure duration(1 day)
  • Radiation dose(1 day)
  • Myocardial infarction(30 days)
  • Length of stay post-procedure(30 days)
  • Overall procedure duration(1 day)
  • All clinically relevant bleeding (BARC ≥2), overall and by access site(30 days)
  • All vascular complications, overall and by access site(30 days)
  • All-cause death(30 days)
  • Stroke(30 days)
  • Major adverse cardiovascular events(30 days)
  • Radiation dose(1 day)
  • Conversion rate to alternative vascular access site(30 days)
  • Tertiary site utilised to treat vascular complication(30 days)
  • Failure to perform angiogram of primary access site at completion of TAVI(1 day)

研究者

发起方
The Alfred
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Zhou

Principal Investigator

The Alfred

研究点 (3)

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