A Prospective, Multicenter, Single-arm Clinical Study Was Conducted to Evaluate the Safety and Efficacy of Intravascular Interventional Surgical Instrument Control System and Related Consumables for Remote Delivery, Operation, and Withdrawal of Interventional Surgical Instruments (Guide Wire, Catheter, Stent, Balloon) During Endovascular Interventional Surgery for Lower Extremity Arteriosclerosis Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 主要终点
- Surgical technique success rate
研究概览
简要总结
This trial was a prospective, multicenter, single-group design. To undergo endovascular treatment of lower extremity arteriosclerosis obliterans After the subjects were selected and enrolled, the surgeons used the endovascular interventional surgical instrument control system developed by Shanghai Aopeng Medical Technology Co., Ltd. and the consumables of the endovascular interventional surgical instrument control system for the interventional hand Instrumentation (guide wire, catheter, stent, balloon) for remote delivery, manipulation, and withdrawal
详细描述
This study will verify the safety and effectiveness of the device in human peripheral vascular diseases, and verify 1. the degree of precision of its operation 2. the function of reducing radiation
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet all the following criteria to be included in the group.
- •Age: 18 years old or above, regardless of gender.
- •Suffering from arteriosclerosis obliterans of lower limbs, it has the indication of endovascular treatment.
- •Volunteer to participate in the test and sign the informed consent form.
排除标准
- •General criteria: If any of the following criteria is met, it cannot be included in the group.
- •Pregnant or lactating women, or women of childbearing age with positive pregnancy test results.
- •The target vessels were treated by arterial bypass grafting.
- •Subjects participated in other clinical trials within 3 months before the screening period.
- •Allergic history or contraindication of antiplatelet drugs, anticoagulants, anesthetics, contrast agents, scaffold materials and their coating drugs.
- •Severe infection that is difficult to control.
- •Vascular criteria: According to the CTA judgment of the diseased vessels, if any of the following criteria is met, they can not be included in the group.
- •Perforation, dissection or aneurysm of the diseased vessel or the proximal vessel of the diseased vessel.
- •The investigator believed that the vascular conditions were not suitable for the use of the test medical device.
结局指标
主要结局
Surgical technique success rate
时间窗: immediately after operation
The proportion of subjects with successful surgical technique in the total enrolled subjects was achieved after the intravascular treatment of lower extremity arteriosclerosis occlusion with experimental medical instruments.
Equipment technical success rate
时间窗: immediately after operation
After the endovascular treatment was completed by the surgeon using the experimental medical instrument, the proportion of subjects with successful equipment technology was achieved in the total enrolled subjects.
次要结局
- Total radiation exposure per operation (surgeon, subject operating table side)(The whole process from the beginning to the end of the operation was recorded.)
- Satisfaction rate of equipment operation (convenience, stability)(Immediately after)
- Rutherford grading change(4 days after surgery or discharge (depending on which comes first))