NL-OMON51852尚未招募3 期
Drug-Coated Balloons versus Drug-Eluting Stents for Treatment of De-Novo Coronary Artery Lesions in Patients with Stable Coronary Artery Disease - the COATED Trial. - The COATED Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 230
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
- •Age >= 18 years
- •Stable angina or dyspnea and the presence of a single de-novo lesion in a
- •native coronary artery causing myocardial ischemia, eligible for PCI based on a
- •formal local heart team decision
- •Reference diameter of the vessel is 2.5-4.0 mm
- •The lesion is suitable for both treatment with DCB and DES
排除标准
- •Dissection affecting the flow (TIMI score<3), significant recoil (>30%) or
- •coronary perforation after predilation
- •Reference diameter of the vessel is <2.5 mm or >4.0 mm
- •Bifurcation lesion, requiring a two-stent technique
- •In-stent restenosis
- •Unprotected left main lesion
- •Chronic total occlusion
- •Acute cononary syndrome
- •Cardiogenic shock
- •Severe kidney disease defined as an eGFR < 30 ml/min
- •Pregnancy
- •Life expectancy < 12 months
- •Inability to give written consent
研究者
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