PRospective Evaluation of Vascular Alterations in CT Angiography After Intervention With Drug-coated Balloon (PREVAIL) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Changes in ΔFFR CT before and after DCB procedure
研究概览
简要总结
This prospective, multicenter observational cohort study aims to investigate changes in target lesion hemodynamic parameters, diameter stenosis, plaque characteristics of CCTA before and after the DCB procedure and evaluate their association with clinical outcomes.
详细描述
This prospective, multicenter observational cohort study will include patients with coronary artery disease who underwent drug-coated balloon (DCB) treatment and had coronary computed tomography angiography (CCTA) performed at baseline. Follow-up CCTA will be conducted two years after the index DCB procedure. The study aims to evaluate changes in target lesion hemodynamic parameters, diameter stenosis, and plaque characteristics on CCTA before and after DCB treatment, and to assess their association with subsequent 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Age ≥ 19
- •Patients who took CCTA and were found to have coronary artery disease requiring reperfusion
- •Patients who underwent DCB within 3 months after CCTA and whose clinical presentation remained largely unchanged from the time of CCTA.
- •The target lesion is a de novo lesion with a vessel diameter between 2.25mm and 3.00mm
- •Patients deemed suitable for coronary intervention using drug-coated balloon by clinical assessment
- •Patients who have been adequately informed about this study and have voluntarily provided written consent to participate.
排除标准
- •The target lesion is an in-stent restenosis lesion
- •Patient requiring emergency salvage stenting in target lesion
- •Patients with a stent previously implanted in the same vessel
- •Lesions involving chronic total occlusion or prior coronary artery bypass grafting (CABG).
- •Patients with eGFR (estimated glomerular filtration rate) < 45 ml/min/1.73mm2
- •Patients with coronary artery calcium score ≥ 1000 as determined by CCTA
- •Patients with an expected survival of less than 5 years
- •Pregnant or breastfeeding patients
- •Patients deemed inappropriate to participate in this study based on the judgment of study investigators
研究组 & 干预措施
Patients treated with a drug-coated balloon for de novo lesions.
Patients who underwent DCB within 3 months after CCTA and whose clinical presentation remained largely unchanged from the time of CCTA.
结局指标
主要结局
Changes in ΔFFR CT before and after DCB procedure
时间窗: From baseline CCTA to follow-up CCTA performed 2 years after the index PCI
次要结局
- Changes in plaque characteristics before and after DCB procedure(From baseline CCTA to follow-up CCTA performed 2 years after the index PCI)
- Changes in diameter stenosis before and after DCB procedure(From baseline CCTA to follow-up CCTA performed 2 years after the index PCI)
研究者
Bon-Kwon Koo
Professor
Seoul National University Hospital