REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Favorable functional outcome
研究概览
简要总结
The aim of the study was to establish a clinical and advanced imaging database of acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China, and to investigate the predictors and potential mechanisms of futile recanalization after mechanical thrombectomy.
详细描述
The time-window of mechanical thrombectomy for ischemic stroke has extended from 4.5 hours to 24 hours based on the results of the DAWN and DEFUSE 3 trials. However, evidence on the effectiveness and safety of mechanical thrombectomy within 24 hours in the real-world is insufficient.
This is a multi-center, prospective, registry cohort study that acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China. A retrospective dataset was also build in these stroke centers for analysis. A total of 1600 patients with advanced imaging data were anticipated to be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Older than 18 years;
- •Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombectomy
- •Large vessel occlusion of cerebral anterior circulation (ICA, MCA-M1 or MCA-M2) confirmed by CTA or MRA, planned to receive or received stenting or aspiration thrombectomy
- •Time intervals ≤ 24 hours from stroke onset to groin puncture.(fulfilled the inclusion of DAWN or DEFUSE 3 trial if the time intervals from stroke onset to groin puncture was ≥6 hours)
- •mRS score ≤2 before admission
- •Informed consent obtained for longitudinal enrolled patients, waived of consent for retrospectively included cases
排除标准
- •Had a history of infective disease, immunity disease, radiotherapy at head or neck, carotid dissection or other carotid disease.
- •Unable to receive CT or MR scan due to heart failure, cardiac pacemaker, metal implants or claustrophobia, etc.
- •Unable to be injected with contrast agent due to allergy, renal dysfunction, etc.
- •Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)
- •Already participated in other drug trials
结局指标
主要结局
Favorable functional outcome
时间窗: 3 months from stroke onset
proportion of mRS score 0-2 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome
次要结局
- recanalization post-operation((Day 0) immediately the surgeon thought the thrombectomy completed and performed a second cerebral angiography .)
- Excellent functional outcome at 90 days(3 months from stroke onset)
- Ordinal distribution of mRS at 90 days(3 months from stroke onset)
- EQ-5D score at at 90 days(3 months from stroke onset)
- Neurological improvement at 24 hours(24 hours from stroke onset)
- recanalization at 24 hours(24 hours after thrombectomy completed)
研究者
Yunyun Xiong
Professor of Neurology and Stroke Center
Beijing Tiantan Hospital