Nordic-Baltic-British Left Main Revascularization Study (NOBLE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,201
- 试验地点
- 2
- 主要终点
- Combined endpoint of death, stroke, non-index treatment related MI and new revascularization (PCI or CABG)
研究概览
简要总结
Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis.
In a clinical, randomized, 5-year follow-up study to compare essential clinical outcome parameters in patients with unprotected left main (LMCA) disease, treated with coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) using drug eluting stents (DES).
DES-PCI of unprotected LMCA disease is non-inferior to CABG concerning the 2-year rate of death, myocardial infarction, stroke or new revascularization and concerning the 5-year rate of death.
详细描述
Design:
Randomised open multicentre trial.
Patients:
Number 1,200
Randomisation:
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable, unstable angina pectoris or ACS.
- •Significant lesion* of LMCA ostium, mid-shaft and/or bifurcation and with no more than three additional non-complex** PCI lesions.
- •Patient eligible to be treated by CABG and by PCI
- •Signed informed consent. *Visually assessed diameter stenosis >50% or fractional flow reserve <0.
- •**Length <25 mm, non-CTO, non-2-stent bifurcation, non-calcified and non-tortuous vessel morphology coronary lesion.
排除标准
- •ST-elevation infarction within 24 hours.
- •CABG clearly better treatment option (LMCA stenosis and >3, or complex** additional coronary lesions)
- •Patient is in too high risk for CABG.
- •Expected survival <1 year.
- •Allergy to aspirin, clopidogrel or ticlopidine.
- •Allergy to Biolimus. **Length >25 mm, CTO, 2-stent bifurcation, calcified or tortuous vessel morphology coronary lesion.
结局指标
主要结局
Combined endpoint of death, stroke, non-index treatment related MI and new revascularization (PCI or CABG)
时间窗: From date of first randomisation until a total number of 275 events is reached (or max 5 years).
次要结局
- Individual endpoints of death, stroke and non-index treatment related MI(30 days, yearly through 5 years and when a total number of 275 events is reached.)
- Combined endpoint of death, stroke and non-index treatment related MI(30 days, yearly through 5 years and when a total number of 275 events is reached.)
- All cause mortality(10 years)
- New revascularization by CABG or PCI(30 days, yearly through 5 years and when a total number of 275 events is reached.)
- Death(30 days, yearly through 5 years and when a total number of 275 events is reached.)
- CCS angina score(30 days, yearly through 5 years and when a total number of 275 events is reached.)
- NYHA functional class(30 days, yearly through 5 years and when a total number of 275 events is reached.)
- Syntax score(Baseline)
- Definite stent thrombosis/symptomatic graft occlusion(30 days, yearly through 5 years and when a total number of 275 events is reached.)
- Duration of admission for index treatment(Baseline)
研究者
Evald Hoej Christiansen
MD, DMSc
Aarhus University Hospital Skejby