NCT05415995Unknown不适用
A Prospective, Multicenter, Randomized Controlled Trail Using Drug-coated Balloon to Treat Below The Knee Arterial Stenosis or Occlusion
Zhejiang Zylox Medical Device Co., Ltd.20 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2022年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 202
- 试验地点
- 20
- 主要终点
- Rate of primary patency of the target lesion
研究概览
简要总结
This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.
详细描述
This trail is conducted in several centers all around China. 202 subjects with below the knee arterial stenosis or occlusion will be recruited and randomized, this trail compares the efficacy and safety of Drug-coated Balloon (Zylox-Tonbridge) with a similar balloon catheter producted by Acotec. The subjects will be followed up when discharged /in 30 days/ 6 months.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years；
- •≥70% diameter stenosis or occlusion in the target below-the-knee lesion；
- •Rutherford Category 3-6；
- •Subjects are willing to sign informed consent；
排除标准
- •Planned major limb amputation within 30 days after the procedure;
- •In-stent stenosis in the target lesion;
- •Severely calcified target lesions；
- •Creatinine>2.5mg/dL;
- •History of allergies to anesthetics, contrast agents；
- •Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint；
- •Other circumstances judged by researchers that are not suitable for enrollment.
结局指标
主要结局
Rate of primary patency of the target lesion
时间窗: 180 days
Primary patency is defined as no target lesion occlusion, no clinical symptom driven target lesion revascularization and major limb amputation.
次要结局
- Success rate of the technique(Immediately after the intervention)
- Success rate of the operation(Within 7 days)
- Success rate of the device(Intraoperation)
研究者
研究点 (20)
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