Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 11
- 主要终点
- Safety - Freedom from MALE-POD at 30 days
研究概览
简要总结
This is a prospective, multi-center, pilot feasibility study to document the effects of adventitial delivery of temsirolimus or temsirolimus with dexamethasone sodium phosphate injection, USP, after revascularization of femoropopliteal lesions in symptomatic patients with moderate to severe claudication (Rutherford 2-3) or critical limb ischemia (CLI) with rest pain (Rutherford 4). Subjects will be followed for up to 60 months post index procedure.
详细描述
To begin to assess the safety and effectiveness of Bullfrog Micro-Infusion Device adventitial deposition of temsirolimus or temsirolimus with dexamethasone in maintaining luminal patency and composite safety endpoints in patients with clinical evidence of moderate to severe claudication or critical limb ischemia with rest pain after revascularization of one or more angiographically significant lesion(s) in superficial femoral or popliteal arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（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
- 未提供
研究组 & 干预措施
Group 1 - temsirolimus injection
Temsirolimus Injection (0.4 mg/mL) and 20% contrast in Group 1
干预措施: Temsirolimus (Drug)
Group 2 - temsirolimus and dexamethasone injection
Temsirolimus Injection (0.4 mg/mL), Dexamethasone Sodium Phosphate Injection, USP (3.2 mg/mL) and 20% contrast in Group 2
干预措施: Temsirolimus and dexamethasone sodium phosphate (Drug)
结局指标
主要结局
Safety - Freedom from MALE-POD at 30 days
时间窗: 30 days post intervention
Freedom from MALE-POD at 30 days
Effectiveness - Primary patency
时间窗: 12 months post intervention
Primary patency (adjudicate by angio core lab)
Effectiveness - Freedom from CD-TLR
时间窗: 12 months post intervention
Freedom from clinically driven target lesion revascularization (CD-TLR)) at 12 months.
次要结局
未报告次要终点