Safety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization in the Treatment of Intracranial Aneurysms: A Prospective, Multicenter, Randomized, Open, Controlled, Superiority Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 264
- 试验地点
- 9
- 主要终点
- Incidence of symptomatic cerebral infarction within 48 hours postoperation
研究概览
简要总结
The purpose of this study is to evaluate the safety differences between intracranial support catheter and guide catheter for stent-assisted embolization in the treatment of unruptured intracranial aneurysms in the anterior circulation.
详细描述
This is a prospective, multicenter, randomized, open, controlled, superiority trial carried out in 9 research centers over China. Patients are randomized 1:1 to therapy either intracranial support catheter or guide catheter. Taking the guide catheter as a control, to evaluate whether the safety of intracranial support catheter for stent-assisted embolization in the treatment of unruptured intracranial aneurysms in the anterior circulation is superior than that of the control.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 and≤70 years, any gender;
- •Preoperative modified Rankin Scale (mRS) score 0-2;
- •Subject has an unruptured intracranial aneurysm in the anterior circulation diagnosed by DSA/CTA/MRA (accept the results from other hospital)；
- •No intracranial hemorrhage and recent cerebral infarction (DWI indicates hyperintense lesions) are founded by preoperative MRI+DWI;
- •Subject is assessed as suitable for stent-assisted coil embolization (SACE) treatment (except flow diverter stent);
- •Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form.
排除标准
- •Inadequate antiplatelet therapy before surgery (more than 3 days);
- •Subject with atrial fibrillation, patent foramen ovale, atrial septal defect, ventricular septal defect, and other diseases causing cardiogenic embolism;
- •Inability to perform cranial MRI+DWI preoperatively and within 48 hours postoperatively;
- •Hypertension that does not respond well to medical treatment (systolic blood pressure>185 mmHg and/or diastolic blood pressure>110 mmHg);
- •Preoperative active bleeding or bleeding tendency (INR>3);
- •Random blood glucose<2.7mmol/L or >22.2mmol/L;
- •Heart, lung, liver and kidney failure or other serious diseases (intracranial tumor, intracranial arteriovenous malformation, severe infection, DIC, previous myocardial infarction, history of severe psychosis, etc.);
- •Subject who will not cooperate or tolerate interventional operation;
- •Anticipated life expectancy<1 year;
- •Allergy, resistance or contraindication to one or more of the following: contrast agents, anesthetics, antiplatelet drugs, anticoagulants;
- •Participated or participating in another drug or device clinical trial within 1 month prior to enrollment;
- •Pregnant or breast-feeding woman;
- •Other circumstances judged by researchers that are not suitable for enrollment;
- •Catheter could not pass through due to obvious intracranial vessel stenosis or tortuosity determined from imaging;
- •Multiple aneurysms and more than one aneurysm requiring treatment;
- •The aneurysm body has arterial branches.
研究组 & 干预措施
experimental group
Intracranial Support Catheter
干预措施: Intracranial Support Catheter (Device)
control group
Guide Catheter
干预措施: Guide Catheter (Device)
结局指标
主要结局
Incidence of symptomatic cerebral infarction within 48 hours postoperation
时间窗: within 48 hours postoperation
Symptomatic cerebral infarction is defined as NIHSS score increased by≥4 points compared with preoperation, along with imaging confirmed to be caused by infarction.
次要结局
- Incidence of Serious Adverse Events (SAE)(up to 90 days)
- Incidence of symptomatic cerebral infarction at 7 days postoperation or at discharge(7 days postoperation or discharged)
- Incidence of Adverse Events (AE)(up to 90 days)
- Incidence of new-onset DWI positive postoperation(within 48 hours postoperation)
- Rate of catheter-related complications(Intraoperation)
- Rate of mRS score 0-2 at 90 days(90±14 days postoperation)
- All-cause mortality within 90 days(up to 90 days)