NCT05078619进行中（未招募）不适用
Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation: the PRO-TAVI Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- UMC Utrecht
- 入组人数
- 466
- 试验地点
- 13
- 主要终点
- composite of all-cause mortality, myocardial infarction, stroke and type 2-4 bleeding, in accordance to VARC-3 criteria
研究概览
简要总结
The aim of this trial is to evaluate the safety and cost effectiveness of omission of percutaneous coronary intervention of significant coronary artery disease in patients scheduled to undergo transcatheter aortic valve implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Severe AoS meeting the criteria stated by the ESC in the ESC/EACTS Guidelines for the management of valvular heart disease AND considered symptomatic (NYHA functional class ≥ 2);
- •TAVI decided by multidisciplinary Heart Team taken into account the international standards by ESC and guidelines of Dutch Society for Cardiology (NVVC);
- •≥ 1 stenosis in epicardial coronary artery (> 2.5mm) or bypass graft. Stenosis is considered significant if angiographic 70-99% or angiographic 40-70% with positive hemodynamic parameters.
- •Written informed consent.
排除标准
- •Unprotected LM-stenosis or equivalent
- •No PCI-eligible stenosis
- •Contraindication for DAPT
- •Life expectancy < 1 year
结局指标
主要结局
composite of all-cause mortality, myocardial infarction, stroke and type 2-4 bleeding, in accordance to VARC-3 criteria
时间窗: 12 months from randomization
次要结局
- stroke(4 months - 12 months - total follow up 5 years)
- Composite of all-cause mortality, myocardial infarction, stroke, in accordance with VARC-3 criteria(4 months - 12 months - total follow up 5 years)
- all-cause mortality(4 months - 12 months - total follow up 5 years)
- Target lesion revascularization(4 months - 12 months - total follow up 5 years)
- Target vessel revascularization(4 months - 12 months - total follow up 5 years)
- rehospitalization(4 months - 12 months - total follow up 5 years)
- myocardial infarction(4 months - 12 months - total follow up 5 years)
- BARC bleeding(4 months - 12 months - total follow up 5 years)
- Left ventricular function measured by echocardiography(12 months)
- VARC-3 bleeding(4 months - 12 months - total follow up 5 years)
- urgent and elective revascularization(4 months - 12 months - total follow up 5 years)
- Cost-effectiveness of omission of PCI using QALYs(4 months - 12 months)
- Cost-effectiveness of omission of PCI using Incremental Cost Effectiveness Ratios(4 months - 12 months)
- Quality of life assessed by Euro Quality of Life 5D Questionnaire(4 months - 12 months)
- Quality of life assessed by SF-36 Questionnaire(4 months - 12 months)
- Anginal status (CCS)(4 months - 12 months)
- NYHA classification(4 months - 12 months)
- Acute kidney injury stage 3 and 4(4 months - 12 months - total follow up 5 years)
研究者
Michiel Voskuil, MD, PhD
Professor in Cardiology
UMC Utrecht
研究点 (13)
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