EUCTR2013-002210-12-ES进行中（未招募）1 期
A randomized, comparative effectiveness study of complete versus culprit-only revascularization strategies to treat multi-vessel disease after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction - COMPLETE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Men and women within 72 hours after successful PCI (preferably using a drug eluting stent) to the culprit lesion for STEMI. PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a pharmacoinvasive strategy where PCI is performed routinely 3-12 hours after initiation of fibrinolysis AND
- •2. Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has:
- •(i) at least 70% diameter stenosis (visual estimation) or
- •(ii) at least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ? 0.80
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1950
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1950
排除标准
- •1. Planned revascularization of non-culprit lesion
- •2. Planned surgical revascularization
- •3. Non-cardiovascular co-morbidity reducing life expectancy to < 5 years
- •4. Any factor precluding 5 year follow-up
- •5. Prior Coronary Artery Bypass Graft (CABG) Surgery
研究者
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