The Impact of Coronary Chronic Total Occlusion Percutaneous Coronary Intervention on Culprit Vessel Physiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in coronary flow
研究概览
简要总结
Following successful CTO PCI, a multitude of physiological and anatomical changes take place. Contemporary techniques such as dissection/re-entry or lumen-lumen wiring may influence the immediate and longer term follow up of these features. It is not known whether changes in this level of physiology and anatomy in the context of CTO vessels correlate with each other, or with quality of life and exercise capacity.
This study aims to take physiological measurements of absolute coronary flow, resistance and pressure and intra-coronary imaging immediately after successful CTO PCI. The investigators will relate these to each other and to the method of revascularisation, comparing changes in these groups at three months follow up.
QoL measurements, and exercise testing will be carried out to see if there is a relationship between physiological and anatomical changes with exercise capacity and quality of life.
Results from this study could shed light on optimisation of CTO PCI procedural and clinical outcomes.
详细描述
Following successful chronic total occlusion (CTO) percutaneous coronary intervention (PCI), a multitude of physiological and anatomical changes take place. Contemporary techniques such as dissection/re-entry or lumen-lumen wiring may influence the immediate and longer term follow up of these features. It is not known whether changes in this level of physiology and anatomy in the context of CTO vessels correlate with each other, or with quality of life and exercise capacity.
This study aims to take physiological measurements of absolute coronary flow, resistance and pressure and intra-coronary imaging immediately after successful CTO PCI. The investigators will relate these to each other and to the method of revascularisation, comparing changes in these groups at three months follow up.
Quality of life measurements, and exercise testing will be carried out to see if there is a relationship between physiological and anatomical changes with exercise capacity and quality of life.
Results from this study could shed light on optimisation of CTO PCI procedural and clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •18 years of age
- •Presence of a coronary chronic total occlusion (CTO) scheduled for elective percutaneous coronary angioplasty (PCI)
- •Evidence of viability in the CTO Territory
排除标准
- •< 18 year of age
- •Unable to give informed consent
- •Known severe chronic kidney disease (creatinine clearance ≤30 mL/min), unless the patient is on dialysis
- •Unable to receive antiplatelets or periprocedural anticoagulation
- •Contraindications to adenosine
- •Any study lesion characteristic resulting in the expected inability to deliver FD-OCT catheter at the distal vessel post CTO PCI (e.g. moderate or severe vessel calcification or tortuosity)
- •Pregnancy, planning pregnancy during study period, or breastfeeding
结局指标
主要结局
Change in coronary flow
时间窗: 3 months
change in coronary flow at baseline and follow up
Change in coronary resistance
时间窗: 3 months
change in coronary absolute resistance at baseline and follow up
次要结局
- Change in exercise work load(3 months)
- Change in coronary anatomy(3 months)
- Change in quality of life(3 months)
- Change in coronary pressure measurements(3 months)