Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Ischemia-driven Target Lesion Revascularization (TLR)
研究概览
简要总结
To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.
详细描述
Today, coronary artery disease is often treated by placing a metal stent inside the vessel that serves as a permanent scaffold. However, it is hypothesized that the stent is no longer needed once the artery has healed. This study will evaluate the safety of a bioresorbable (non-permanent) stent for the treatment of coronary artery disease. The stent is designed to restore blood flow to the artery which allows the artery to remodel (heal), and then resorb from the body. The stent supports the vessel during the critical 90-day healing process, and then gradually resorbs and is cleared from the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Evidence of myocardial ischemia or a positive functional study.
- •Normal CK-MB.
- •Target lesion must be located in a native coronary artery where target vessel diameter is ≥ 2.9 mm and ≤ 3.3 mm and target lesion length is ≤ 12 mm, both assessed by on-line QCA and IVUS
- •Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥
- •Staged procedures are allowed in non-target vessels >24 hours before or > 30 days after REVA stent implantation
排除标准
- •A myocardial infarction (CK-MB or Troponin > 3 times normal) within 72 hours of the procedure, has signs or symptoms of an ongoing myocardial infarction or has any visible thrombus
- •Unprotected left main coronary disease with >50% stenosis
- •The target vessel is totally occluded (TIMI Flow 0 to 1)
- •Target lesion involves a bifurcation (a lesion with a side branch >2.0 mm in diameter containing a >50% stenosis)
- •Target lesion is located within a segment supplied by distal graft
- •Target lesion has possible or definite thrombus
研究组 & 干预措施
REVA Medical ReZolve Stent
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent
干预措施: ReZolve Stent (Device)
结局指标
主要结局
Ischemia-driven Target Lesion Revascularization (TLR)
时间窗: 6 months
Defined as any clinically-driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
次要结局
- QCA & IVUS derived parameters(12 months)
- Major Adverse Coronary Events(60 months)
- Procedural and Technical Success(Acute)