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临床试验/NCT06971718
NCT06971718招募中不适用

Drug Coated Balloons in Coronary Bifurcation Lesions. A Feasibility Study Looking at Computational Flow Dynamics, Ischaemic and Anatomical Changes to the Bifurcation

University of East Anglia1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年10月10日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Physiological assessment

研究概览

简要总结

The coronary arteries are blood vessels that provide oxygen rich blood to the muscle of the heart. If these vessels become narrowed or blocked, this can lead to chest pain (called angina) or heart attacks. Narrowings are usually treated using metal scaffolds called drug eluting stents. However, in one in five cases where the narrowing occurs at a branching point, treating it with stents is more challenging and can cause complications. A possible alternative treatment is using a special type of balloon called a drug-coated balloon. This balloon is inflated in the blood vessel and releases medicine to help widen the blood vessel and the procedure is completed without leaving any metallic scaffold behind.

This study aims to compare drug coated balloons with drug eluting stents to see which treatment works better for narrowing that occurs at branching points. We will used advanced imaging techniques to create computer models of blood flow in the vessels, and we will follow up with patients over tie to see how well the treatments work.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Age 18 or over
  • Any bifurcation lesion amenable to a provisional main vessel treatment strategy
  • A main vessel diameter of 2.5mm or more and side branch diameter of >2mm
  • Any patient with stable angina, silent ischaemia, unstable angina or NSTEMI
  • Able to give informed consent

排除标准

  • Cardiogenic shock
  • LVEF <30%
  • STEMI (as unable to give informed consent)
  • eGFR <30
  • Severe asthma contraindicating use of adenosine
  • High degree AV block on 12 lead ECG precluding the use of adenosine
  • Pregnancy
  • Inability to consent
  • Left main stem coronary bifurcation lesions

结局指标

主要结局

Physiological assessment

时间窗: 3-9 months

Physiological assessment measuring: * FFR (Main vessel and side branch) * Wall sheer stress

OCT derived anatomical measure

时间窗: 3-9 months

Mean lumen area main vessel and mean lumen area side branch

次要结局

  • Late lumen loss(3-9 months)
  • Device oriented clinical endpoints(3-9 months)
  • Patient focused endpoint: Angina(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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