NL-OMON50705招募中不适用
TransCatheter Aortic Valve Implantation and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention versus Conventional Surgical Aortic Valve Replacement and Coronary By-Pass Grafts for Treatment of Patients with Coronary MultiVessel Disease and Aortic Valve Stenosis - TCW
Maatschap Cardiologie Zwolle0 个研究点目标入组 170 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 170
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
- •1) Symptomatic patients aged >=70 years with AS fulfilling one of these criteria
- •(AVA <=1 cm2; mean gradient >=40mmHg; Aortic jet velocity >4 m/sec; or Velocity
- •index <= 0.25) feasible for treatment by both trans femoral or subclavian
- •approach TAVI as well as conventional SAVR and where the HT decides that
- •treatment is needed (final decision is left to the HT)
- •2) Presence of >=2 de novo coronary lesions of >=50% diameter stenosis on visual
- •estimation located in any of main epicardial coronary arteries or side branches
- •of a lumen caliber of more than 2 mm or single LAD lesion with more than 20 mm
- •length or involving a bifurcation (complex), feasible for treatment with CABG
- •as well as PCI (HT decision)
- •3) Patients willing and capable to provide written informed consent
排除标准
- •1) Patients in cardiogenic shock or acute heart failure, requiring inotropic
- •agents during procedure and/or i.v. diuretics <48 hours before procedure
- •2) Left ventricular ejection fraction <30%
- •3) Concomitant presence of other than aortic valve disease requiring
- •intervention
- •4) Previous CABG, SAVR, TAVI or thoracotomy for any other reason
- •5) Bicuspid or unicuspid aortic valve
- •6) Recent myocardial infarction (less than 2 weeks)
- •7) Involvement of left main trifurcation (all three branches being larger than
- •8) Expected total stent length more 60mm per vessel
- •9) FFR measurement judged impossible
- •10) Life expectancy <1 year
- •11) Known malignancy
- •12) Contraindication for dual antiplatelet therapy or expected surgical
- •intervention requiring interruption of Dual Antiplatelet Therapy (DAPT) in the
- •first 6 months
- •13) Reduced renal function (GFR <29 ml/min/1.73m2; KDOQI stage 4 and 5)
- •14) Previous disabling stroke, TIA in the last 6 months, or known severe
- •stenosis of carotid or vertebral arteries
- •15) Participation in other investigational clinical trials
研究者
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