跳至主要内容
临床试验/NCT04649190
NCT04649190已完成不适用

Post-TAVI Coronary Access Study

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
PCI device success

研究概览

简要总结

Coronary access after trans-catheter aortic valve implantation (TAVI) remains a major challenge. With the evolution of TAVI procedure and the inclusion of lower-risk patients with aortic stenosis, future coronary access is an even greater concern, because this lower-risk patient group has a greater cumulative risk of requiring coronary angiography for acute coronary events compared to their octogenarian counterparts.

It is only speculated that the intra-annular position of the self-expandable valves together with the frame covering coronary ostia would impose a significant technical challenge as compared to the balloon-expandable valve (1). However, this remains to be proven. With any valve used, increased catheter manipulations may result in longer fluoroscopy times, larger volumes of contrast, and reduced imaging quality due to non-selective injections (2).

Although complex, coronary procedures after TAVR are considered relatively safe and feasible on experience hands (3-6). A number of techniques to increase the likelihood of successful coronary intubation after TAVR have been described in the published reports and include the use of intracoronary guidewires (1), as well as balloon-assisted tracking with guideliner extension (7). It is therefore essential to fully understand the potential challenges of coronary angiography and PCI in this specific patient population. Guidance by a specific algorithm may help to overcome difficulties in coronary angiography and facilitate selective coronary intubation particularly during primary PCI (8).

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
— 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Prior TAVI for aortic stenosis or regurgitation in bicuspid or tricuspid valve
  • Clinical indication for PCI

排除标准

  • Prior TAVI valve-in-valve procedures
  • Prior TAVI-in-TAVI procedures

结局指标

主要结局

PCI device success

时间窗: 5 year

次要结局

  • Final TIMI flow(5 year)
  • Incidence of procedural complications(5 year)
  • Successful withdrawal of the device delivery system(5 year)
  • Attainment of a final in-stent or in-scaffold residual stenosis of <20%(5 year)
  • Successful delivery, balloon expansion, and deployment of the first assigned device, at the intended target lesion(5 year)
  • Successful selective engagement of guiding catheter(5 year)
  • Procedural mortality(5 year)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Issi Barbash

Prof

Sheba Medical Center

研究点 (1)

Loading locations...

相似试验