DIRECT-SAFE: A Randomized Controlled Trial of DIRECT Endovascular Clot Retrieval Versus Standard Bridging Thrombolysis With Endovascular Clot Retrieval Within 4.5 Hours of Stroke Onset
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 44
- 主要终点
- Modified Rankin Scale (mRS)- ordinal analysis
研究概览
简要总结
The study will be a multicentre, prospective, randomized, open label, blinded endpoint (PROBE) phase 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients within 4.5 hours of stroke onset. Randomised patients will be stratified for site of baseline arterial occlusion into one of three groups: 1. internal carotid artery (ICA) 2. middle cerebral artery (MCA) 3. basilar artery (BA). Patients will be randomised to either bridging intravenous thrombolysis with endovascular clot retrieval (ECR), or direct endovascular clot retrieval.
详细描述
The DIRECT-SAFE trial will include patients with acute ischemic stroke, who are ≥18 years of age and are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset. Patients will be assessed for large vessel occlusion to determine their eligibility for randomization into the trial. Eligible vessel occlusions include the internal carotid artery, basilar artery or middle cerebral artery (M1 or M2). Patients will be consented after large vessel occlusion is confirmed based on standard care multimodal imaging.
Patients will be recruited in Australia, New Zealand, China, Taiwan, Vietnam, Singapore and Europe. Randomisation either direct to ECR or standard thrombolytic therapy and ECR shall be in a 1:1 ratio.
All patients will have a multimodal MR (or CT/CTP at investigator's discretion if MRI not possible) at 18 to 30 hours post treatment to assess reperfusion, recanalization, ischemic core growth and hemorrhagic transformation. Final follow up will occur at Day 90.
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)
盲法说明
Blinded core laboratory adjudications of the primary outcome. NIHSS and mRS (secondary outcomes) performed by blinded 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
- •Patients presenting with acute ischemic stroke eligible using standard criteria to receive IV thrombolysis within 4.5 hours of stroke onset
- •Patient's age is ≥18 years
- •Intra-arterial clot retrieval treatment can commence (groin puncture) within 6 hours of stroke onset.
- •Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery
排除标准
- •Intracranial hemorrhage (ICH) identified by CT or MRI
- •Rapidly improving symptoms at the discretion of the investigator
- •Pre-stroke mRS score of ≥ 4 (indicating previous disability)
- •Hypodensity in >1/3 MCA territory on non-contrast CT
- •Contra indication to imaging with contrast agents
- •Any terminal illness such that patient would not be expected to survive more than 1 year
- •Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
- •Pregnant women
结局指标
主要结局
Modified Rankin Scale (mRS)- ordinal analysis
时间窗: 3 months
Modified Rankin Scale (mRS) 0-2 or no change from baseline
次要结局
- Angiographic reperfusion(Baseline)
- modified Rankin Scale (mRS)- ordinal analysis(3 months)
- Death(3 months)
- Symptomatic intracranial haemorrhage (sICH)(24 hours)