Rescue Endovascular Treatment After Neurological Deterioration in Initially Mild Basilar Artery Occlusion in an Extended Time Window
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization.
研究概览
简要总结
A prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial to evaluate whether best medical management (BMM) combined with endovascular therapy (EVT) improves neurological outcomes compared to BMM alone in patients with progressive acute mild ischemic stroke due to basilar artery occlusion within an extended time window.
详细描述
This trial aims to evaluate whether best medical management (BMM) combined with endovascular therapy (EVT) improves neurological outcomes compared to BMM alone in patients with progressive acute mild ischemic stroke due to basilar artery occlusion within an extended time window. The study used a stratified block randomization method. A central randomization system was used to assign subjects to the experimental group and the control group in a 2:1 ratio for each center.
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
- Single (Outcomes Assessor)
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.
- •Initially mild ischemic stroke, defined as an initial NIHSS score <6, with no prior endovascular treatment for the index ischemic event.
- •Basilar artery occlusion, or vertebral artery occlusion resulting in complete interruption of antegrade flow into the basilar artery, documented by CTA, MRA, or DSA during the initially mild phase and before qualifying neurological deterioration.
- •Qualifying neurological deterioration occurring between 24 hours and 7 days after initial symptom onset, or after the last known well if symptom onset is unknown.
- •Qualifying neurological deterioration is defined as an NIHSS score ≥10 with either a ≥4-point increase in total NIHSS or a ≥2-point increase in the NIHSS level-of-consciousness score from the initial NIHSS score and must be documented by certified medical personnel at a medical facility, including a referring hospital.
- •Posterior circulation Acute Stroke Prognosis Early CT Score (pc-ASPECTS) ≥6 on noncontrast CT or diffusion-weighted MRI performed after qualifying neurological deterioration.
- •Time from qualifying neurological deterioration to randomization ≤24 hours.
- •Written informed consent obtained from the patient or a legally authorized representative.
排除标准
- •Symptom progression due to intracranial hemorrhage, brain edema, or other clear causes (including but not limited to infarct hemorrhagic transformation, new infarction in non-occluded vascular regions, obstructive hydrocephalus, severe infection, high fever, heart or kidney dysfunction, hypovolemia, or severe electrolyte disturbances).
- •prestroke mRS >
- •Factors in the target vessel that are expected to prevent completion of endovascular treatment.
- •Concurrent anterior and posterior circulation strokes.
- •Prior imaging confirmed or investigator-assessed chronic basilar artery occlusion.
- •Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations.
- •Intracranial hemorrhage within the past 6 months, including parenchymal brain hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.
- •Gastrointestinal or urinary tract bleeding, acute myocardial infarction, cranial trauma, or major surgery within the past month.
- •Presence of active bleeding, coagulation disorders, or uncorrectable bleeding tendencies.
- •Platelet count <40×10^9/L, or INR >2 during anticoagulation therapy (irreversible).
- •Severe heart, liver, or kidney dysfunction or other severe systemic late-stage diseases.
- •Known allergy to iodine contrast agents or other treatment-related drugs.
- •Medically uncontrolled refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) (Note: Participants can be included if their blood pressure is controllable with medication and maintained at an acceptable level).
- •Uncontrollable blood glucose <2.8 mmol/L or >22.2 mmol/L.
- •Pregnancy or breastfeeding.
- •Life expectancy <6 months.
- •Participation in other clinical studies that may affect outcome assessment.
- •Investigator's judgment that the patient is unsuitable for participation in this study or may face significant risks (e.g., due to mental illness, cognitive, or emotional disorders preventing understanding and/or compliance with study procedures and/or follow-up).
研究组 & 干预措施
Best Medical Management Group
Participants receive best medical management only. Best Medical Treatment and maximum supportive care according to local guidelines, not including mechanical thrombectomy, no intra-arterial treatment.
Endovascular Therapy Group
Researchers can choose to deal with the stenosis or occlusion of blood vessels according to their own judgment, including stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.
干预措施: Endovascular Treatment (Procedure)
结局指标
主要结局
Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization.
时间窗: 90 (±7)days after procedure
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization.
时间窗: 90 (±7)days after randomization
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
次要结局
- Shift analysis of the improvement trend in modified Rankin Scale (mRS) scores at 90 (±7) days after randomization.(90 (±7) days after procedure)
- Proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 (±7) days after randomization.(90 (±7) days after procedure)
- Change in NIHSS score from baseline at 24 hours postoperatively.(24 hours after procedure)
- EQ-5D-5L scale at 90 (±7) days after randomization.(90 (±7) days after procedure)
- Change in NIHSS score from baseline at discharge or 5-7 days postoperatively.(Discharge or 5 -7 days after procedure.)
- Successful reperfusion postoperatively.(At the end of the operation)
- Shift analysis of the improvement trend in modified Rankin Scale (mRS) scores at 90 (±7) days after randomization.(90 (±7) days after randomization)
- Proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 (±7) days after randomization.(90 (±7) days after randomization)
- Change in NIHSS score from baseline at 24 after randomization.(24 hours after randomization)
- EQ-5D-5L scale at 90 (±7) days after randomization.(90 (±7) days after randomization)
- Change in NIHSS score from baseline at discharge or 5-7 days after randomization.(Discharge or 5 -7 days after randomization)
- Change in NIHSS score from baseline at discharge or 7±1 days after randomization.(Discharge or 7±1 days after randomization)
- Change in NIHSS score from baseline at 24 hours after randomization.(24 hours after randomization)
- Change in NIHSS score from pre-randomization baseline at 24 hours after randomization.(24 hours after randomization)
- Change in NIHSS score from pre-randomization baseline at 7±1 days after randomization or discharge.(Discharge or 7±1 days after randomization)