NL-OMON51090招募中不适用
The TAVI PCI (optimal timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention) Trial - TAVI PCI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients >=18 years with severe aortic stenosis and concomitant coronary
- •artery disease accepted for transfemoral TAVI with an Edwards SAPIEN
- •Transcatheter Heart Valve* by transfemoral access and PCI by the
- •multidisciplinary Heart Team
- •Severe aortic stenosis defined as aortic valve area (AVA) <=1.0 cm2 and/or
- •mean pressure gradient >=40 mmHg (echocardiography) and at least one of:
- •1) Dyspnea
- •2) Angina symptoms
- •3) Syncope
- •4) Decline in left ventricular ejection fraction <50%, symptoms or fall in
- •blood pressure on exercise testing, or presence of high-risk criteria (peak
- •transaortic velocity >5.5 m/s, severe valve calcification, peak transaortic
- •velocity progression >=0.3 m/s per year, or severe pulmonary hypertension with
- •systolic pulmonary artery pressure >60 mmHg) according to current guidelines(6)
- •At least one coronary artery lesion with 40-90% diameter stenosis and iwFR
- •<=0.89 or with >90% diameter stenosis on coronary angiogram (by visual
- •estimation) in a coronary artery >=2.5 mm in diameter and Thrombolysis in
- •Myocardial Infarction (TIMI) flow grade III, deemed amenable to PCI within 45
- •days before or after TAVI
- •Written informed consent
排除标准
- •TAVI by transapical, subclavian, or transaortic access
- •Admission with acute myocardial infarction within 30 days before randomization
- •Elective coronary revascularization within 3 months before randomization
- •Previous coronary artery bypass grafting (CABG)
- •Syntax Score I >=33
- •Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12
- •inhibitor (clopidogrel, ticagrelor or prasugrel), except for patients on oral
- •anticoagulation
- •Planned open heart surgery
- •Known pregnancy at the time of inclusion
- •Life expectancy <1 year due to other severe non-cardiac disease
- •Participation in another clinical study with an investigational product
- •Acute COVID-19 infection
- •Patient with previously treated aortic stenosis
研究者
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