NL-OMON45959已完成4 期
A prospective multicenter randomized post market all-comer trial to assess the safety and effectiveness of the SUPRAFLEX sirolimus-eluting coronary stent system for the treatment of atherosclerotic lesion(s). - TALENT
Cardialysis0 个研究点目标入组 350 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
- 350
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
- •1. Male or female patients >=18 years;
- •2. Presence of one or more coronary artery stenoses of >=50% in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation.
- •3. The vessel should have a reference vessel diameter ranging from >=2.25 mm to <=4.5 mm (no limitation on the number of treated lesions, vessels, or lesion length)
排除标准
- •1. Known pregnancy or breastfeeding at time of randomization;
- •2. Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor;
- •3. Any PCI treatment within 6 months (<6 months) prior to the index procedure.
- •4. Concurrent medical condition with a life expectancy of less than 12 months.
- •5. The patient is unwilling/not able to return for outpatient clinic at 1 month and 12 months follow-up.
- •6. Currently participating in another trial and not yet at its primary endpoint.
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