A Prospective, Randomized, Multi-center IDE Study to Assess the SeQuent Please ReX Drug Coated PTCA Balloon Catheter for the Treatment of In-stent Restenosis (RESPECT-ISR)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Freedom from target lesion failure (TLF)
研究概览
简要总结
The objective of this study is to establish reasonable assurance of safety and effectiveness to support an FDA premarket approval (PMA) application for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter as indicated.
详细描述
The investigation is a prospective, randomized, multi-center IDE study comparing the SeQuent Please ReX to plain old balloon angioplasty (POBA). The study will be conducted at up to 30 investigational sites and enroll up to 296 patients with in-stent restenosis of a metallic coronary stent who are suitable candidates for PTCA procedures. After consent and assessment of inclusion and exclusion criteria, eligible patients will be randomized to either the SeQuent Please ReX or POBA arm based on a 2:1 randomization ratio. Subjects will return for follow-up through 5 years.
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
- 未提供
排除标准
- •Subjects must not meet any of the following angiographic exclusion criteria after lesion preparation:
- •Dissection type C - F
- •TIMI < III
- •Residual stenosis >30%
结局指标
主要结局
Freedom from target lesion failure (TLF)
时间窗: 12 months post-procedure
TLF is defined as the composite of any of the following events: * Clinically-driven target lesion revascularization (TLR) * Myocardial infarction (MI; not clearly attributable to a nontarget vessel) * Cardiovascular death
次要结局
- Late lumen loss (LLL)(9 months post-procedure)
- Myocardial infarction (MI)(12 months post-procedure and annually thereafter to study completion)
- All death(12 months post-procedure and annually thereafter to study completion)
- Device, lesion, and procedural success(Post-procedure (device and lesion success) and at discharge (procedural success))
- Cardiovascular death(12 months post-procedure and annually thereafter to study completion)
- Major adverse cardiac events (MACE)(12 months post-procedure and annually thereafter to study completion)
- Clinically-driven target lesion revascularization (TLR)(12 months post-procedure and annually thereafter to study completion)
- Stent thrombosis(12 months post-procedure and annually thereafter to study completion)
- Clinically-driven target vessel revascularization (TVR)(12 months post-procedure and annually thereafter to study completion)