OPtimizing REperfusion by Primary Intra-Arterial ThRomboLysis for Medium Vessel Occlusion (PEARL-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- The modified Rankin Scale score (mRS) 0-1
研究概览
简要总结
PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of primary intra-arterial thrombolysis in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset.
详细描述
PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of primary intra-arterial thrombolysis in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset. The primary outcome is the proportion of patients with a 90-day modified Rankin Scale (mRS) of 0-1. Eligible patients will be randomly assigned at a ratio of 1:1 into the intervention group to receive primary intra-arterial thrombolysis in addition to standard medical treatment, or the control group to receive only standard medical management. A total of 530 participants (265 per group) are anticipated to be recruited for this study.
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
- •Aged 18 years or older.
- •Clinical diagnosis of acute ischemic stroke.
- •CT angiography (CTA) or MR angiography (MRA) confirmed primary isolated medium vessel occlusion (i.e. an occlusion of the co-/non-dominant M2, the M3/M4 segment of the MCA, the A1/A2/A3 segment of the ACA, or the P1/P2/P3 segment of the PCA).
- •Baseline NIHSS ≥
- •Treatment (arterial puncture) can be initiated 5.1 Within 6 hours of last known well (LKW) OR 5.2 Within 6 to 24 hours of LKW AND evidence of salvageable brain tissue on CT perfusion or perfusion-diffusion MRI (ischemic core volume <50mL, hypo-perfused tissue volume to ischemic core volume ratio >1.4, mismatch volume >10mL). Hypo-perfused tissue is defined as Tmax >6s on CT perfusion or perfusion MRI. Ischemic core is defined as rCBF <30% on CT perfusion or ADC <620μm2/s on diffusion MRI.
- •Signed informed consent.
排除标准
- •Evidence of intracranial hemorrhage.
- •Pre-stroke mRS score ≥
- •Rapidly improving symptoms, in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of <6 at randomization.
- •The intervention procedure is unlikely to be completed as assessed by the investigator.
- •Suspected cerebral vasculitis, septic embolization, or vascular occlusion due to infective endocarditis.
- •Suspected arterial dissection.
- •Severe allergy to contrast agents (non-mild rash allergy) or absolute contraindication to iodine contrast.
- •Known genetic or acquired bleeding disposition or anticoagulant factors deficiency.
- •Coagulation disorder with INR >1.7 or use of new oral anticoagulants within 48 hours prior to symptom onset.
- •Platelet count <50×10^9/L.
- •Any active or recent bleeding (gastrointestinal, urinary tract bleeding, etc.), or previous parenchymal organ surgery or biopsy in the last 1 month.
- •Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, refractory to treatment.
- •Known severe renal insufficiency with glomerular filtration rate <30 ml/min or blood creatinine >220 μmol/L (2.5 mg/dl).
- •Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma).
- •Anticipated life expectancy <6 months due to advanced disease (e.g., malignancy, severe cardiopulmonary disease, etc.).
- •Women who are pregnant or breastfeeding.
- •Participation in other clinical trials.
- •Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
研究组 & 干预措施
Intervention group
Intra-arterial thrombolysis as adjunct to endovascular treatment, in addition to standard medical treatment
干预措施: Intra-arterial thrombolysis as adjunct to endovascular treatment (Combination Product)
Control group
Only standard medical treatment
干预措施: Standard medical treatment (Other)
结局指标
主要结局
The modified Rankin Scale score (mRS) 0-1
时间窗: 90 (±14) days
The proportion of mRS 0-1 at 90 (±14) days.
次要结局
- Level of disability(90 (±14) days)
- The modified Rankin Scale score (mRS) 0-2(90 (±14) days)
- Quality of life (EQ-5D-5L)(90 (±14) days)
- Neurologic deficit (NIHSS score) changes(24 (±12) hours)