Safety and Efficacy Analysis of Stent-assisted Coil Embolization in the Treatment of Acute Ruptured Intracranial Aneurysms in the Perioperative Period.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Number of participants with imaging-confirmed stent-related stroke within 30 days post-procedure
研究概览
简要总结
To determine the perioperative safety and efficacy of stent-assisted coil embolization of intracranial aneurysms in the acute phase. Intravenous antiplatelet drugs that are clinically easy to administer, have good reproducibility and good controllability are used.The program focuses on exploring the safety of emergency stent-assisted embolization of intracranial wide carotid aneurysms, and then determines the effectiveness of treatment in preventing rebleeding and preventing aneurysm recurrence in the long term.
详细描述
Based on the current clinical research results and existing clinical needs, this paper conducts a study on how to carry out stent-assisted embolization of ruptured aneurysms in the acute stage, aiming to explore the safety and embolization effect of stent-assisted embolization aneurysms in the acute stage under the protection of intravenous antiplatelet drugs, focusing on the probability of complications and related clinical consequences in the perioperative period. Thus, it provides a reasonable, safe and effective interventional treatment plan for a large number of patients with ruptured aneurysms who need interventional treatment in clinical practice.
Study endpoints:
Main endpoints: 1. Complications related to surgical treatment; 2. New stent-related (possibly related) ischemic events and bleeding events within 30 days after surgery. 3. Perioperative-related mortality rate (death from any cause and Neurological dysfunction with NIHSS greater than 4 points due to complications)
Secondary study endpoints: 1. Degree of embolism immediately after surgery (R grade); 2. 30-day patient mRS score; 3. The degree of aneurysm embolism at 1 year after surgery; 4. New treatment-related ischemia and bleeding events 30 days to 1 year after thrombosis; 4. Proportion of restenosis within the stent at 1 year; 5 mRS score at 1 year postoperatively.
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
- •Patients aged 18-80 with a single ruptured cystic aneurysm at the center, or multiple aneurysms with a clear responsible lesion, only treat the responsible lesion
- •Aneurysms with a wide neck, neck ≥4mm, or neck/body ratio >1/2
- •Treatment performed within 7 days of the last hemorrhage
- •Patients undergoing interventional treatment using a stent, including cases of remedial stent use.
- •Hunt & Hess grade 1-3
排除标准
- •Exclude patients who meet the inclusion criteria but fail to undergo successful SAC embolization
- •Exclude non-cystic aneurysms, such as dissection, pseudoaneurysm, and distal aneurysm patients
- •Patients with other cerebrovascular diseases, including AVM, DAVF, Moyamoya disease, and arterial stenosis greater than 50%
- •Patients unable to use intravenous antiplatelet drugs
- •Patients with poor condition prior to aneurysm rupture, mRS ≥ 2
- •Exclude pregnant patients
- •Exclude patients with other severe preoperative diseases, such as malignant tumors or cardiopulmonary and renal diseases
- •Patients with multiple aneurysms where the responsible lesion cannot be identified and treatment is done for all
结局指标
主要结局
Number of participants with imaging-confirmed stent-related stroke within 30 days post-procedure
时间窗: From the procedure to 30 days post-procedure
Stroke was defined as an acute neurological deficit lasting \>24 hours or resulting in death, with corresponding neuroimaging evidence. Events were adjudicated as stent-related by the independent clinical events committee. Confirmation required head CT, MRI, or DSA performed from the time of procedure completion to postoperative day 30. The number of participants experiencing such events was reported.
Number of participants with perioperative NIHSS score ≥4 or all-cause mortality.
时间窗: from the start of the procedure to postoperative day 30.
Perioperative period is defined as the time from the start of the procedure to postoperative day 30. The number of participants with a National Institutes of Health Stroke Scale (NIHSS) score of 4 or higher at any time during this period, or death from any cause during this period, was reported. NIHSS is a 15-item neurological examination scale used to evaluate the severity of stroke, with scores ranging from 0 to 42; higher scores indicate greater severity.
次要结局
- Degree of immediate post-operative aneurysm occlusion(Immediately post-procedure)
- 30-day post-procedure mRS score(From immediately post-procedure to post-operative day 30)
- Degree of aneurysm occlusion at 1 year post-operation(From the post-operative period up to 1 year post-procedure)
- Treatment-related ischemic or hemorrhagic events occurring between 1 month and 1 year post-procedure(From 1 month to 1 year post-procedure)
- Proportion of in-stent restenosis at 1 year post-procedure(At 1 year post-procedure)
- mRS score at 1 year post-procedure(At 1 year post-procedure)