NL-OMON54209招募中不适用
Sirolimus-coated balloon versus drug-eluting stent in native coronary vessels - TRANSFORM II
Fondazione Ricerca e Innovazione Cardiovascolare, No profit organization0 个研究点目标入组 315 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 315
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; -all patients with a clinical indication to PCI (stable
- •coronary arterydisease or acute coronary syndromes); -native coronary artery
- •lesion in a vessel with diameter >2.0 mm and *3.5 mm at visual estimation; -
- •maximum lesion lenght: 50 mm. - informed consent to participate in the study
排除标准
- •target lesion/vessel with any of the following characteristics: - concomitant
- •PCI at the same vessel with any device (vessels are considered: left anterior
- •descending, circumflex or right coronary artery); - pre-dilatation of the
- •target lesion not performed or not successful (residual stenosis >30%); -
- •severe calcification of the target vessel, at lesion site but also proximally;
- •- highly tortuous vessel which could impair device delivery to the lesion site
- •following Investigator*s judgement; - previous stent implantation at target
- •vessel (left anterior descending artery; circumflex artery; right coronary
- •artery); - bifurcation lesion where side branch treatment is anticipated; -
- •left main stem stenosis >50%; - target lesion is in left main stem. -Lesion
- •is located within asaphenous vein graft
研究者
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