A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Efficacy and Safety of a Balloon Microcatheter for Clinical Use
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Rate of device success
研究概览
简要总结
The primary objective of this trial is to evaluate the safety and efficacy of a new balloon microcatheter in patients with intracranial artery stenosis.
详细描述
This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of a balloon microcatheter in the treatment of intracranial artery stenosis. A total of 56 patients are planned to be included. The endpoints include device success, target vessel dissection, target vessel occlusion, mortality and cerebrovascular events, assessed during the in-hospital until discharge.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years of age
- •Patients with intracranial artery stenosis (Degree of stenosis: ≥70%)
- •Target vessel reference diameter must be visually estimated to be 1.25 mm to 4.50 mm
- •Willingness to participate in this clinical trial and signing the consent form for patients or their legally authorised representatives
排除标准
- •The proximal end of the target vessel is extremely tortuous, severely angulated, or heavily calcified, making it difficult for the device to reach the target vessel
- •Pre-existing severe respiratory, hepatic, or renal diseases (e.g., creatinine ≥ 3.0 mg/dL) or coagulation disorders
- •Disabling stroke with a baseline mRS score ≥ 3 points
- •Non-atherosclerosis diseases
- •Patients with stroke caused by branch occlusion
- •Patients who were participating in other clinical trials who had not yet reached the primary clinical endpoint
- •Known hypersensitivity to aspirin, heparin, anesthetics and contrast agents
- •Investigators consider the patient who is not suitable for enrolling in the present trial
研究组 & 干预措施
balloon microcatheter
For the treatment of intracranial artery stenosis, balloon microcatheter would combine the advantages of balloon dilatation first and then, if necessary, the additional deployment of a self-expandable stent via the same balloon microcatheter lumen.
干预措施: balloon microcatheter (Device)
结局指标
主要结局
Rate of device success
时间窗: During interventional procedure
The system was successfully delivered to the target site, the balloon was successfully inflated at the lesion area, the therapeutic device was successfully delivered via the microcatheter, and the system was successfully withdrawn.
Rate of device success
时间窗: During interventional procedure
The system was successfully delivered to the target site, the balloon was successfully inflated at the lesion area, the therapeutic device was successfully delivered via the microcatheter, and the system was successfully withdrawn.
次要结局
- Incidence of cerebrovascular events, including transient ischemic attack (TIA), ischemic stroke, and hemorrhagic stroke.(Perioperatively (During the in-hospital until discharge))
- Rate of target vessel dissection, target vessel occlusion(Perioperatively (During interventional procedure))
- Mortality(Perioperatively (During the in-hospital until discharge))
- Proportion of adverse events or severe adversary event(Perioperatively (During the in-hospital until discharge))
- Incidence of device defects(Perioperatively (During the in-hospital until discharge))
- Incidence of cerebrovascular events, including transient ischemic attack (TIA), ischemic stroke, and hemorrhagic stroke.(Perioperatively (During the in-hospital until discharge))
- Rate of target vessel dissection, target vessel occlusion(Perioperatively (During interventional procedure))
- Mortality(Perioperatively (During the in-hospital until discharge))
- Proportion of adverse events or severe adversary event(Perioperatively (During the in-hospital until discharge))
- Incidence of device defects(Perioperatively (During the in-hospital until discharge))