NCT02504307已完成4 期
Randomized Evaluation of Vascular Healing After Implantation of Sirolimus Eluting Stent Inspiron™ Versus Its Own Bare Metal Version- An OCT Evaluation After 3 Months Follow-up
Scitech Produtos Medicos Ltda1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
Prospective, single center, randomized and non-inferiority study, to include up to 60 patients with de novo coronary artery disease. Patients will be followed at 30 days, 3, 6 and 12 months. At 3 months all patients will be submitted to angiographic and OCT evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •one or two de novo lesions (> 50% visual estimation)
- •lesion diameter between 2.5 and 3.5 mm
- •lesion length up to 33 mm.
排除标准
- •MI within the last 72 hours
- •restenotic lesion.
研究组 & 干预措施
Inspiron
Experimental
Sirolimus Eluting Stent Inspiron
干预措施: Sirolimus Eluting Stent Inspiron (Device)
Cronus
Active Comparator
Bare Metal Stent
干预措施: Bare Metal Stent (Device)
结局指标
主要结局
Safety
时间窗: 3 months
Percentage of strut coverage by OCT
次要结局
未报告次要终点
研究者
研究点 (1)
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