Endovascular Treatment of Chronic Intracranial Artery Occlusion: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 382
- 主要终点
- Stroke or death within 30 days after enrollment, or any ischemic stroke of the qualifying artery after 30 days through 12 months after enrollment
研究概览
简要总结
Comparison of the efficacy and safety of endovascular treatment versus medical treatment in patients with chronic intracranial artery occlusion.
详细描述
This study is a multicenter, outcome-blinded, randomized controlled trial designed to evaluate the safety and efficacy of endovascular therapy combined with standard medical therapy versus standard medical therapy alone in patients with chronic intracranial artery occlusion. A total of 382 patients (191 per group) aged ≥18 years with chronic occlusion of the unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery confirmed by CTA, MRA, or DSA will be enrolled and randomly assigned to the experimental group (endovascular therapy + standard medical therapy) or the control group (standard medical therapy alone). The primary endpoint is stroke or death within 30 days after enrollment, or any ischemic stroke related to the responsible artery occurring from 30 days to 12 months after enrollment. Secondary endpoints include any stroke or death within 30 days after randomization; any stroke within 12 months after the procedure; disabling stroke within 12 months after the procedure; fatal stroke within 12 months after the procedure; any death within 12 months after the procedure; mRS score at 12 months; NIHSS score at 12 months; successful reperfusion rate of endovascular therapy; and procedure-related complications.
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
- None
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
- •Occlusion of the unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery, as confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA)
- •Modified Rankin Scale (mRS) score of 0-2
- •Presence of symptoms related to the occluded vessel, as determined by the physician, with the most recent symptom onset occurring more than 4 weeks and within 6 months prior to enrolment
- •The subject or their legally authorised representative has provided written informed consent for the study
排除标准
- •Evidence of hemorrhage on CT or MRI
- •Large hemispheric infarction involving >50% of the middle cerebral artery territory on CT or MRI
- •Severe pre-stroke disability (modified Rankin Scale score ≥2) or life expectancy <12 months
- •Major comorbidities that may interfere with outcome assessment and follow-up (e.g., severe heart failure, renal failure, etc.)
- •Uncontrolled seizure at the time of stroke onset
- •Baseline platelet count <50,000/μL
- •Severe, persistent hypertension that remains uncontrolled despite active management (systolic blood pressure >220 mmHg or diastolic blood pressure >120 mmHg)
- •Known inherited or acquired bleeding diathesis, coagulation factor deficiency, or recent oral anticoagulant therapy with an international normalized ratio (INR) >3
- •Suspected septic emboli or suspected bacterial endocarditis
- •Known allergy to iodine, heparin, or anaesthetics, or other definite contraindications to endovascular procedures
- •Pregnant women
- •Other severe, progressive, or terminal diseases (as judged by the investigator), or life expectancy <24 months
- •Prior attempted endovascular recanalization therapy before randomization
- •Current participation in other studies involving investigational drugs or devices
- •Evidence of intracranial tumour on CT or MRI (except meningioma)
- •Excessive tortuosity of cervical vessels on CTA/MRA that may preclude endovascular therapy
研究组 & 干预措施
Test group
Endovascular treatment combined with standard pharmacological treatment
干预措施: Endovascular treatment (Procedure)
control group
Standard pharmacological treatment
干预措施: Standard pharmacological treatment (Drug)
结局指标
主要结局
Stroke or death within 30 days after enrollment, or any ischemic stroke of the qualifying artery after 30 days through 12 months after enrollment
时间窗: Within 30 days post-enrollment; and 30 days to 12 months post-enrollment
A stroke is defined as rapid loss of neurological function due to ischaemia or a haemorrhage. CT or MRI scanning is necessary to identify the stroke.
次要结局
- Disabling stroke within 12 months post-procedure(12 months post-procedure)
- Successful reperfusion rate(End of the procedure)
- Any stroke within 12 months post-procedure(12 months post-procedure)
- Residual stenosis of target vessel at 12 months(12 months post-procedure)
- Fatal stroke within 12 months post-procedure(12 months post-procedure)
- NIHSS score at 12 months(12 months post-procedure)
- mRS score at 12 months(12 months post-procedure)
- Any death within 12 months post-procedure(12 months post-procedure)
- Any stroke or death within 30 days post-randomization(Within 30 days post-randomization)
- Procedure-related complications(Perioperative period / Within 30 days post-procedure)
研究者
Hu Bo
Director, Head of Neurology, Principal Investigator, Clinical Professor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology