Intra-arterial Thrombolysis for Acute Ischemic Stroke With Medium Vessel Occlusion (RESCUE MeVO)

a Multicenter Prospective Randomized Controlled Trial of Intra-artErial thrombolysiS for aCUte Ischemic strokE With Medium Vessel Occlusion (RESCUE MeVO)

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.

Study Overview

• Status: Recruiting
• Conditions: Infarction; Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Nervous System Diseases; Ischemic Stroke; Medium Vessel Occlusion
• Intervention / Treatment: Drug: Best Medical Treatment; Procedure: Intra-arterial Thrombolysis

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 282
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qi Li, professor; Phone Number: +8618623511778; Email: qili_md@126.com

Study Locations

• China
  • Anhui
    • Fuyang, Anhui, China
      • Recruiting
      • Fu Yang People's Hospital
      • Contact: Juluo Chen; Phone Number: 0558-3010999
      • Principal Investigator: Juluo Chen
    • Fuyang, Anhui, China
      • Recruiting
      • Lin Quan People's Hospital
      • Contact: Susheng Long; Phone Number: 0558-6403761
      • Principal Investigator: Susheng Long
    • Hefei, Anhui, China, 230031
      • Recruiting
      • The Second (Affiliated) Hospital of Anhui Medical University
      • Contact: Qi Li, professor; Phone Number: +8618623511778; Email: qili_md@126.com
      • Principal Investigator: Qi Li, professor
    • Lu'an, Anhui, China
      • Recruiting
      • Shucheng People's Hospital
      • Contact: Jianshang Wen; Phone Number: 0564-8621570
      • Principal Investigator: Jianshang Wen
  • Guangxi
    • Liuchow, Guangxi, China
      • Recruiting
      • Liuzhou Worker's Hospital
      • Contact: Xianfu Lu; Phone Number: 0772-3815345
      • Principal Investigator: Xianfu Lu
  • Zhejiang
    • Lishui, Zhejiang, China
      • Recruiting
      • Lishui Central Hospital
      • Contact: Xiao Peng; Phone Number: 05782285888
      • Principal Investigator: Xiao Peng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

  1. 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;
  2. 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-arterial Thrombolysis plus Best Medical Treatment; Patients in this group will receive intra-arterial thrombolysis plus 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.; Procedure: Intra-arterial Thrombolysis; rhTNK-tPA（Tenecteplase）dose: 0.4 - 1.2mg/min, maximum dose: 16mg. Patients who have not received IVT are recommended to initiate intra-arterial administration at a rate of 0.8 mg/min, whereas those who have received IVT are recommended to receive 0.4 mg/min. The infusion rate may be dynamically adjusted by the operator according to intra-procedural circumstances, with a maximum rate not exceeding 1.2 mg/min.
Other: Best Medical Treatment; Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.	Drug: Best Medical Treatment; Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excellent outcome	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.	Time Frame: 90 ± 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early neurological deterioration	The proportion of patients with an increase of ≥ 4 points in the National Institutes of Health Stroke Scale (NIHSS) score, within 24 ± 12 hours post-randomization. The NIHSS is a standardized 11-item assessment tool designed to quantify neurological deficits in patients with acute stroke. The total score ranges from 0 to 42, with higher values indicating more severe deficits.	24 ± 12 hours
Any neurological improvement	The proportion of patients with a reduction of ≥ 2 points in the National Institutes of Health Stroke Scale (NIHSS) score from baseline at 24 ± 12 hours post-randomization. The NIHSS is a standardized 11-item assessment tool designed to quantify neurological deficits in patients with acute stroke. The total score ranges from 0 to 42, with higher values indicating more severe deficits.	24 ± 12 hours
Early neurological improvement	The proportion of patients with a reduction of ≥ 4 points in the National Institutes of Health Stroke Scale (NIHSS) score from baseline at 24 ± 12 hours post-randomization. The NIHSS is a standardized 11-item assessment tool designed to quantify neurological deficits in patients with acute stroke. The total score ranges from 0 to 42, with higher values indicating more severe deficits.	24 ± 12 hours
Ordinal distribution of mRS	Ordinal distribution of the modified Rankin Scale (mRS) at 90 ± 7 days. The mRS is a widely used 7-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.	90 ± 7 days
Functional independence	The proportion of patients achieving functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 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.	Frame: 90 ± 7 days
Poor functional outcome	Number of participants achieving a poor functional outcome, defined as a modified Rankin Scale (mRS) score of 4-6 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.	90 ± 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	All cause mortality at 90 ± 7 days.	90 ± 7 days
Symptomatic intracranial hemorrhage	The incidence of symptomatic intracranial hemorrhage within 24 ± 12 hours post-randomization	24 ± 12 hours

Collaborators and Investigators

• Sponsor: The Second Hospital of Anhui Medical University
• Investigators: Principal Investigator: Qi Li, professor, The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: September 15, 2025
• First Submitted That Met QC Criteria: September 15, 2025
• First Posted (Actual): September 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Ischemic stroke; Intra-arterial thrombolysis; Medium vessel occlusion; Severe stenosis
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Anatomical; Necrosis; Ischemia; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Stroke; Constriction, Pathologic; Vascular Diseases; Brain Diseases; Nervous System Diseases; Cerebrovascular Disorders; Infarction
• Other Study ID Numbers: YX2025-105(F1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No