NCT05562076尚未招募不适用
A Prospective, Multicenter, Randomized Controlled Trail Using Spot Stenting to Treat Lower Extremity Post-angioplasty Dissection
Zhejiang Zylox Medical Device Co., Ltd.12 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2022年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 224
- 试验地点
- 12
- 主要终点
- primary patency rate at 12 months after operation
研究概览
简要总结
This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 80 years,male or female
- •Lower extremity atherosclerotic occlusive disease
- •After PTA, angiography showed less than 30% residual stenosis of the target lesion (based on visual estimation), and there is one or more dissection(Type A-F)
- •Subjects are able to understand the purpose of the study, demonstrate full compliance with the procedure and follow-up and sign informed consent
排除标准
- •The target lesion has been stented or previously treated with bypass surgery
- •Acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours
- •Cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned
- •More than 30% residual stenosis of the inflow artery (based on visual estimation) after treatment, or there is no outflow artery in the target limb
- •The target lesion was too calcified to undergo PTA or the guide wire could not pass anterograde through the target lesion
- •Planned amputation on the target limb
- •Severe allergy to anticoagulant drugs, antiplatelet drugs, contrast media and Nitinol
- •Uncontrollable infections
- •Women who are pregnant or breastfeeding, or who plan to become pregnant during the duration of the trial
- •Participating in clinical trials of any other drug or medical device and not yet out of the study
- •Other circumstances not suitable for inclusion as judged by the investigator
结局指标
主要结局
primary patency rate at 12 months after operation
时间窗: 12 months
次要结局
- the rate of target limb major amputation(30 days, 6 months,12 months)
- the rate of device defect(Intraoperation, 12 months)
- success rate of the device(Intraoperation)
- success rate of the technique(post operation)
- rate of CD-TLR(6 months,12 months)
- ABI(post operation, 6 months,12 months)
- Rutherford classification(post operation, 6 months,12 months)
- the incidence of major adverse events(30 days, 6 months,12 months)
- the incidence of SAE(Intraoperation, post operation, 30 days, 6 months,12 months)
- the incidence of adverse events(Intraoperation, post operation, 30 days, 6 months,12 months)
研究者
研究点 (12)
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