A Clinical Study on the Safety and Effectiveness of Intracranial Distal Access Catheter in Neurointerventional Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 6
- 主要终点
- Technical success rate
研究概览
简要总结
The study objective is to evaluate the safety and effectiveness of Intracranial Distal Access Catheter in neurointerventional therapy.
详细描述
Patients with mechanical thrombectomy for acute ischemic stroke, treatment of intracranial aneurysms and other ischemic and hemorrhagic diseases, requiring the use of Intracranial Distal Access Catheter to complete the procedure were eligible. At last, 124 retrospective and prospective subjects in 6 centers were screened in this trial, and 114 subjects were successfully enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Age = 18-80 years old.
- •Patients with mechanical thrombectomy for acute ischemic stroke, treatment of intracranial aneurysms and other ischemic and hemorrhagic diseases, requiring the use of Intracranial Distal Access Catheter to complete the procedure (such as poor vascular access conditions, lesions located in secondary or higher branches of cerebral vessels, inability of conventional guiding catheters in place and providing effective support. Treatment with Flow-divert devices, covered stents, stent grafts, etc.)
- •Patients agree to participate in the study and sign the informed consent form.（only prospective enrolled patients)
排除标准
- •Intracranial Distal Access Catheter is used during the interventional therapy of non-neurovascular diseases, such as peripheral vascular and coronary artery diseases.
- •Interventional procedure is performed with other distal catheters or devices with the same function before using Intracranial Distal Access Catheter.
- •Ordinary guiding catheters can be used to establish access to complete the procedure without the use of Intracranial Distal Access Catheter.
结局指标
主要结局
Technical success rate
时间窗: immediately after procedure
It is defined as the proportion of subjects where Intracranial Distal Access Catheter can reach the expected position to successfully deliver the device and meet the treatment needs. Special note: If the patient uses more than one Intracranial Distal Access Catheters during the procedure, as long as any Intracranial Distal Access Catheter is delivered successfully, the patient is considered to achieve successful delivery with Intracranial Distal Access Catheter. Technical success rate (%) = number of patients successfully delivered/number of patients analyzed \* 100%
次要结局
- Catheter delivery success rate(immediately after procedure)
- Incidence of device-related adverse events(from the procedure to patients discharged from the hospital, anticipated average 5 days)
- Incidence of device-related serious adverse events(from the procedure to patients discharged from the hospital, anticipated average 5 days)