NCT02835586已完成3 期
STREAMER : Stent Restenosis and Medicaments Release : Does Local Delivery of Paclitaxel be Safe and Efficient in Stenting of TransAtlantic InterSociety Consensus (TASC) Class C and D Femoropopliteal Artery Lesions
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Percentage of patients with femoropopliteal artery restenosis
研究概览
简要总结
It is a pilot study to evaluate the feasibility and the efficiency of local delivery of paclitaxel after stenting of long femoropopliteal arterial lesions TASC C and D before the realization of a large randomized multicentric study. Patients concerned are in critical ischemia.
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
- •patients with critical ischemia of a lower limb with ankle pressure < 50 mmHg
- •lesions TASC C and D of the superficial femoral or popliteal artery
排除标准
- •patient allergic to paclitaxel
- •patient with a cancer, a neutropenia, with immunosuppressor medicament or chemotherapy
- •patient with contraindication to take 2 anti-aggregants platelets
研究组 & 干预措施
paclitaxel delivery in femoropopliteal artery
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Percentage of patients with femoropopliteal artery restenosis
时间窗: 12 months
defined as restenosis \> 50 % with a velocity pick \> 2,5 on duplex ultrasound
次要结局
- Occurence of amputation free-survival(12 months)
- Occurence of adverse events due to paclitaxel(From1 day to 12 months)
- cumulated rate of morbi-mortality (TCMM)(up to 30 days)
- Number of patients with target lesion revascularization(12 months)
研究者
研究点 (1)
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