NCT00385905已完成4 期
Excel Drug-Eluting Stent Pilot Clinical Registry
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 12-month MACE
研究概览
简要总结
The Trial aims to evaluate long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.
详细描述
30-day, 6-month, and 12-month clinical follow-up and 6 to 9-month IVUS or SCA follow-up to measure long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who should fulfill with criteria of implanting Excel stents.
- •Each patient enrolled is only allowed to implant Excel stents.
- •Each patient are not allowed to be implanted more than 6 Excel stents.Also, 3 over-lapped stents are not allowed to be implanted in the same vessel(3-5mm overlapping needed; length of stents totally are not allowed to be over 80mm; fully post-dilated is essential for overlapping).
- •Patients acknowlegement to the trial is essential.
排除标准
- •AMI withine 1 week.
- •Patients who do not suitable to Excel stenting.(For example, non-tolerant to anti-platelet drug or cardiac/non-cardiac surgery undergoing recently.)
- •Patients who have multiple branch lesions can not apply single Excel stenting.
- •Patients who refuse to sign the Trial Acknowledgement.
- •Patients with intra-stent restenosis.
结局指标
主要结局
12-month MACE
次要结局
- 30-day or 6-month MACE
- 6 to 9-month restenosis rate by SCA follow-up
研究者
研究点 (1)
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