EndovascularTherapy Versus Standard Medical Terapy for Intracranial Large Vessel Occlusion in 24 Hours to 30 Days: A Prospective, Multicenter, Real-world Cohort Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The proportion of patients with functional independence defined as mRS score of 0 - 2 at 90 days after enrollment
研究概览
简要总结
This study is a prospective, multicenter, observational cohort study using a real-world study design. The aim of this study is to compare functional and safety outcomes of intravascular recanalization therapy (with COSIS distal stent protection technology strategy as the core) combined with standard drug therapy in improving functional outcomes in patients with intracranial large vessel occlusion in the ultra late window (24 hours-30 days) compared with standard drug therapy alone.
详细描述
Patients with ischemic stroke whose onset or last known well (LKW) ranged from 24 hours to 30 days, who were confirmed by imaging to have intracranial large vessel occlusion and may still have brain tissue that can be saved were included. The study did not interfere with the choice of treatment options. Patients received intravascular therapy or standard drug treatment, which was determined by clinicians according to the condition, imaging characteristics and the joint decision of doctors and patients. According to the actual treatment of patients, the intravascular treatment cohort and the standard drug treatment cohort were formed, in which the intravascular treatment was centered on the COSIS distal stent protection strategy. The primary outcome is proportion of patients with functional independence defined as mRS score of 0-2 at 90 days after enrollment.
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
- •Age≥18 years
- •The clinical diagnosis was ischemic stroke, and imaging confirmed the presence of intracranial large vessel occlusion
- •The time from LKW or the time of finding symptoms is 24 hours to 72 hours; or more than 72 hours but not more than 30 days, and there are neurological deterioration or fluctuation
- •Imaging findings suggest that there may still be salvageable brain tissue, which meets any of the following conditions: perfusion imaging examination shows that the ischemic core volume < 70 ml and the mismatch ratio > 1.2; CTA or DSA showed moderate or good collateral circulation; MRI-DWI showed a significant mismatch between lesion size and clinical symptoms
- •The modified Rankin Scale score (mRS) before onset was 0-1
- •The subjects themselves or their legal representatives voluntarily participated in the study and signed written informed consent
排除标准
- •Large area cerebral infarction or imaging showed obvious space occupying effect, such as ASPECTS<6 points,or brainstem infarction area exceeded 1/3 of the corresponding anatomical area
- •Isolated extracranial carotid or vertebral artery occlusion
- •Intracranial tumors, arteriovenous malformations or other serious intracranial diseases that may significantly affect the evaluation of the outcome of the study
- •Intracranial hemorrhage occurred in the past 3 months
- •There is a risk of severe coagulation dysfunction, active bleeding or other high bleeding that cannot be corrected
- •Severe liver and kidney function damage, which may affect treatment or follow-up
- •Pregnant or lactating women
- •The estimated survival time is less than 1 year
- •Unable to complete 90-day clinical follow-up or main outcome assessment
- •Participating in other interventional clinical trials that may affect the treatment or outcome evaluation of this study
- •Other circumstances that the researcher believes are not suitable for participating in this study
研究组 & 干预措施
Endovascular Treatment Cohort
Intravascular therapy combined with standard drug therapy, in which the core of intravascular therapy is the cosis distal stent protection strategy.
干预措施: Endovascular Treatment Group (Procedure)
Standard Medical Therapy Cohort
Standard drug therapy alone.It mainly includes antiplatelet therapy or anticoagulation therapy, lipid-lowering therapy, blood pressure and blood glucose management, etc.
干预措施: Standard medication (Other)
结局指标
主要结局
The proportion of patients with functional independence defined as mRS score of 0 - 2 at 90 days after enrollment
时间窗: 90 days after enrollment
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
次要结局
- The recurrence rate of stroke within 90 days after enrollment(90 days after enrollment)
- Transient ischemic attack within 90 days after enrollment(90 days after enrollment)
- National Institutes of Health Stroke Scale (NIHSS) score 90 days after enrollment(90 days after enrollment)
- The overall distribution of mRS at 90 days after enrollment(90 days after enrollment)
- National Institutes of Health Stroke Scale (NIHSS) score 24 hours after treatment(24 hours after treatment)
- National Institutes of Health Stroke Scale (NIHSS) score at discharge(At discharge)
- National Institutes of Health Stroke Scale (NIHSS) score 30 days after enrollment(30 days after enrollment)
- All-cause mortality within 90 days after enrollment(90 days after enrollment)
- Revascularization of target vessels within 90 days after enrollment(90 days after enrollment)
- The technical success rate of the intravascular treatment cohort，successful recanalization of the target vessel with residual stenosis <50% and final mTICI grade≥2b(At the end of the procedure)
- Degree of recanalization in the intravascular treatment cohort(At the end of the procedure)
- Operation time of intravascular treatment cohort(During the procedure)
- Distribution of mRS scores at 6 months after enrollment(6 months after enrollment)
- The recurrence rate of stroke at 6 months after enrollment(6 months after enrollment)
- Transient ischemic attack at 6 months after enrollment(6 months after enrollment)
- All-cause mortality at 6 months after enrollment(6 months after enrollment)
- Revascularization of target vessels at 6 months after enrollment(6 months after enrollment)
- Distribution of mRS scores at 12 months after enrollment(12 months after enrollment)
- The recurrence rate of stroke at 12 months after enrollment(12 months after enrollment)
- Transient ischemic attack at 12 months after enrollment(12 months after enrollment)
- All-cause mortality at 12 months after enrollment(12 months after enrollment)
- Revascularization of target vessels at 12 months after enrollment(12 months after enrollment)
研究者
Xuan Sun
Vice-Director of Interventional Neuroradiology, Department of Neurology
Beijing Tiantan Hospital