a Multicenter Prospective Randomized Controlled Trial of Intra-artErial thrombolysiS for aCUte Ischemic strokE With Medium Vessel Occlusion (RESCUE MeVO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 282
- 试验地点
- 6
- 主要终点
- Excellent outcome
研究概览
简要总结
Acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) or severe stenosis poses a significant clinical challenge. Recent large randomized controlled trials, DISTAL and ESCAPE-MeVO, demonstrated no significant benefit of endovascular therapy in patients with MeVO. Although intra-arterial thrombolysis has shown promise in clinical experience, robust evidence supporting its efficacy in MeVO or severe stenosis-related AIS is still absent. To fill this gap, the RESCUE MeVO trial has been designed as a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study to evaluate the efficacy and safety of intra-arterial thrombolysis in patients with AIS caused by MeVO or severe stenosis.
详细描述
This study is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) trial. Eligible participants will be adults (age >18 years) presenting with acute ischemic stroke (AIS) due to MeVO or severe stenosis (≥70%). Participants who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 1:1 ratio to one of two treatment arms. The control group will receive best medical management alone, while the intervention group will receive best medical management in combination with intra-arterial thrombolysis. Intra-arterial thrombolysis is performed by infusing rhTNK-tPA (Tenecteplase) proximal to the occlusion or severe stenosis for 5-30 minutes, with the decision to continue beyond the first 5 minutes being guided by intraprocedural DSA. The primary objective of this study is to evaluate the efficacy and safety of intra-arterial thrombolysis in patients with acute ischemic stroke caused by MeVO or severe stenosis. The primary endpoint is excellent outcome at 90 days, defined as a score of 0-1 on the modified Rankin Scale (mRS).
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
- •Primary medium vessel occlusion (MeVO) or severe stenosis (≥70%) was detected on CTA, MRA, or DSA, involving arterial segments including M2-M3 of the middle cerebral artery (MCA), A1-A2 of the anterior cerebral artery (ACA), P1-P2 of the posterior cerebral artery (PCA), and the anterior inferior cerebellar artery (AICA), posterior inferior cerebellar artery (PICA), and superior cerebellar artery (SCA)
- •The clinical symptoms were consistent with MeVO, with a NIHSS score 5 - 25, or an NIHSS score of 3-4 in the presence of disabling neurological deficits (e.g., hemianopia, aphasia, or motor dysfunction)
- •Intra-arterial thrombolysis was administered within the following time windows:
- •Acute ischemic stroke within 24 hours of symptom onset or last known well, including stroke with known onset, wake-up stroke and stroke with unknown onset, with no obvious hypodensity on CT and good collateral circulation on CTA;
- •Acute ischemic stroke within 24-72 hours of onset, meeting at least one of the following imaging criteria: a.CT or MR perfusion imaging demonstrating target mismatch, defined as an ischemic core volume <30 mL, a mismatch ratio ≥1.2, and a mismatch volume ≥10 mL.; b.MRI demonstrating DWI-FLAIR mismatch, defined as the presence of acute ischemic lesions on diffusion-weighted imaging (DWI) with no corresponding hyperintense signal on FLAIR, or with FLAIR hyperintense lesions occupying less than one-third of the DWI lesion volume.
- •Signed informed consent obtained
排除标准
- •Pre-stroke mRS ≥ 2
- •Secondary MeVO or severe stenosis caused by endovascular therapy
- •Neuroimaging demonstrated intracranial hemorrhage, subarachnoid hemorrhage, or other hemorrhagic disorders
- •Non-contrast CT demonstrating a clearly hypodense lesion corresponding to the vascular territory
- •Platelet count <100 × 10⁹/L, known bleeding tendency or coagulation factor deficiency, or oral anticoagulant therapy with an international normalized ratio (INR) >3.0
- •Persistent and uncontrolled hypertension, defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg
- •History of intracranial hemorrhage within the past 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage, or subdural hemorrhage
- •Presence of arteriovenous malformations or brain tumors with mass effect
- •Gastrointestinal or urinary tract bleeding, or major surgery within the past 3 months
- •Chronic dialysis or severe renal impairment, defined as a glomerular filtration rate (GFR) <30 mL/min or serum creatinine >220 μmol/L (2.5 mg/dL)
- •Patients with known allergy to thrombolytic agents or their excipients
- •Patients with known allergy to iodinated contrast agents or other established contraindications
- •Pregnant or current breastfeeding
- •Presence of severe systemic comorbidities with a life expectancy of less than 3 months
- •Deemed unsuitable for participation by the investigator for any reason
研究组 & 干预措施
Intra-arterial Thrombolysis plus Best Medical Treatment
Patients in this group will receive intra-arterial thrombolysis plus best medical treatment.
干预措施: Intra-arterial Thrombolysis (Procedure)
Intra-arterial Thrombolysis plus Best Medical Treatment
Patients in this group will receive intra-arterial thrombolysis plus best medical treatment.
干预措施: Best Medical Treatment (Drug)
Best Medical Treatment
Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.
干预措施: Best Medical Treatment (Drug)
结局指标
主要结局
Excellent outcome
时间窗: Time Frame: 90 ± 7 days
Number of participants achieving an excellent outcome, defined as a modified Rankin Scale (mRS) score of 0-1 at 90 ± 7 days follow-up. The mRS is a widely used 7-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
次要结局
- Poor functional outcome(90 ± 7 days)
- Ordinal distribution of mRS(90 ± 7 days)
- Functional independence(Frame: 90 ± 7 days)
- Early neurological deterioration(24 ± 12 hours)
- Any neurological improvement(24 ± 12 hours)
- Early neurological improvement(24 ± 12 hours)
研究者
Qi Li
Professor
The Second Hospital of Anhui Medical University