NL-OMON51591已完成4 期
Comprehensive Medical and Invasive Treatment strategy for patients with significant Left Anterior Descending artery disease - COMMIT-LAD
Zuyderland Medisch Centrum0 个研究点目标入组 460 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 460
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
- •Stable coronary artery disease OR
- •Hemodynamically stable patients with a Non-STE Acute Coronary Syndrome AND
- •Hemodynamically significant LAD disease, as assessed by fractional flow reserve
- •(FFR, <= 0.80) measurements; OR >90% lesion; OR non-invasive evidence of ischemia.
- •Eligibility for complete revascularization (defined as a British Cardiovascular
- •Intervention Society [BCIS] revascularisation index >0.8). Please be aware that
- •in the case of a diffusely diseased LAD and randomisation for the percutaneous
- •arm, optimal medical therapy is seen as LAD-revascularization.
- •The local Heart Team must conclude that:
- •The LAD, irrespective of focal or diffuse disease, is suitable for both
- •LIMA-LAD grafting and PCI (in the case of focal LAD disease).
- •Focally diseased LADs are suitable for PCI.
- •In the case of multivessel disease (2VD or 3VD) CABG not better than one of the
- •study related treatments (for a medical reason e.g. porcelain aorta, poor
- •conduits, comorbidities, frailty etc.). All NON-LAD lesions and coronary
- •arteries must be suitable for FFR guided percutaneous coronary intervention.
- •Age >= 18 and <= 85 years
- •Signed informed consent.
- •Ability to tolerate and no plans to interrupt relevant medical treatment during
- •the duration of the study.
- •Willing to comply with protocol required follow-up.
排除标准
- •Previous CABG
- •Any target lesion with in-stent restenosis within 1 year
- •Significant Left Main involvement
- •Significant valvular heart disease
- •Prior anterior myocardial infarction with clear evidence of residual akinesia
- •and/or dyskinesia
- •Extremely calcified or tortuous vessels precluding LAD FFR measurement or OCT
- •of the LAD.
- •Planned major surgery within the next 12 months
- •Extra-cardiac illness that is expected to limit survival to less than 1 years
- •Allergy or hypersensitivity to any of the study related drugs or devices (e.g.
- •metals, antithrombotic agent etc.)
- •Active participation in another randomized trial
- •Unable to give informed consent or potential for noncompliance with the study
- •protocol in the judgment of the investigator
- •Pregnant at the time of screening or unwilling to use effective birth control
- •measures while dual antiplatelet therapy is required.
研究者
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