NCT06236828已完成不适用
The MRI-based Evaluation of Safety and Efficacy of EVT and SMT: A Retrospective, Multicenter Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of modified Rankin Scale (mRS) score of 0-3 at 90 days
研究概览
简要总结
Acute Basilar Artery Occlusion (ABAO), a condition with a high risk of mortality or disability (up to 80%). The safety and efficacy of endovascular thrombectomy (EVT) in ABAO remains uncertain due to inconsistent evidence from random controlled trials (RCTs).
Recent studies have explored the use of MRI in ABAO, this study aims to assess the efficacy and safety of EVT and standard medical therapy (SMT) in the treatment of ABAO within 24 hours of onset. It also aims to explore the feasibility and prognostic value of MRI-based assessment of ABAO infarction using AI image analysis software.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preliminary diagnosis of posterior circulation ischemic stroke based on clinical symptoms or imaging examinations.
- •Confirmation through CTA/MRA/DSA that there is occlusion of the basilar artery or the V4 segment of the vertebral artery leading to functional occlusion of the basilar artery.
- •Age 18 years and older.
- •Symptom onset within 24 hours.
- •Having a baseline MRI evaluation, including at least DWI and T2 FLAIR sequences (baseline MRI for the EVT group before the operation; baseline MRI for the SMT group within the treatment window (within 4.5 hours of onset) for thrombolytic patients before or during the thrombolysis process should initiate as early as possible; baseline MRI for the SMT group for extended treatment window patients (between 4.5 hours to 12 hours of onset) should initiate as early as possible).
排除标准
- •mRS score ≥ 3 before onset;
- •Significant neuroimaging changes such as cerebral hemorrhage, cerebellar mass lesion, acute hydrocephalus, etc., are present;
- •Lack of follow-up results within 90 days after operation;
- •Life expectancy < 3 months;
- •Baseline imaging and crucial clinical data are missing;
- •Special cases involving pregnancy and lactation;
- •Severe systemic diseases or advanced cancer that may potentially interfere with the prognosis;
- •Allergic reactions to contrast agents or nickel-titanium alloys;
- •Currently participating in other clinical trials;
- •Pre-existing neurological disorders or psychiatric conditions that could affect the assessment of the disease.
结局指标
主要结局
Rate of modified Rankin Scale (mRS) score of 0-3 at 90 days
时间窗: 90 days after EVT or SMT
The mRS score range from 0 (no disability) to 6 (death)
次要结局
- Mortality(90 days after EVT or SMT)
- Rate of mRS score of 0-2(90 days after EVT or SMT)
- Rate of non-hemorrhage severe adverse event(Within 72 hours after EVT or SMT)
- Improvement of mRS score(90 days after EVT or SMT)
- Surgical instrument-related Complications(Within 72 hours after EVT or SMT)
- Rate of symptomatic intracranial hemorrhage (sICH)(Within 72 hours after EVT or SMT)
- Change of the National Institutes of Health Stroke Scale (NIHSS) score comparing to baseline(24 hours and 5-7 days (or at discharge) after EVT)
- Rate of successful revascularization (mTICI 2b-3) in target blood vessels of EVT group(Immediately after the completion of endovascular therapy.)
- Rate of Intracranial hemorrhage (ICH)(Within 72 hours after EVT or SMT)
研究者
研究点 (1)
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