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