Intra-arterial Thrombolysis for Acute Ischemic Stroke With Medium Vessel Occlusion

NCT07185022 | Recruiting DMC

• 1 other identifier: YX2025-105(F1)
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Stroke; Cerebrovascular Disorders; Brain Diseases; Nervous System Diseases; Vascular Diseases; Ischemic Stroke; Infarction; Medium Vessel Occlusion

Keywords

Ischemic stroke; Medium vessel occlusion; Stroke; Intra-arterial thrombolysis; Severe stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Ordinal distribution of mRS

  90 ± 7 days

• Functional independence

  Frame: 90 ± 7 days

• Poor functional outcome

  90 ± 7 days

• Early neurological deterioration

  24 ± 12 hours

• Any neurological improvement

  24 ± 12 hours

Other Outcomes (2)

• Symptomatic intracranial hemorrhage

  24 ± 12 hours

• All cause mortality

  90 ± 7 days

Study Arms (2)

Intra-arterial Thrombolysis plus Best Medical Treatment

EXPERIMENTAL

Patients in this group will receive intra-arterial thrombolysis plus best medical treatment.

Procedure: Intra-arterial Thrombolysis; Drug: Best Medical Treatment

Best Medical Treatment

OTHER

Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.

Drug: Best Medical Treatment

Interventions

Intra-arterial Thrombolysis PROCEDURE

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.

Intra-arterial Thrombolysis plus Best Medical Treatment

Best Medical Treatment DRUG

Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.

Best Medical Treatment; Intra-arterial Thrombolysis plus Best Medical Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

Study Sites (6)

Fu Yang People's Hospital

Fuyang, Anhui, China

RECRUITING

Lin Quan People's Hospital

Fuyang, Anhui, China

RECRUITING

The Second (Affiliated) Hospital of Anhui Medical University

Hefei, Anhui, 230031, China

RECRUITING

Shucheng People's Hospital

Lu'an, Anhui, China

RECRUITING

LiuZhou Worker's Hospital

Liuchow, Guangxi, China

RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders; Brain Diseases; Nervous System Diseases; Vascular Diseases; Ischemic Stroke; Infarction; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Cardiovascular Diseases; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pathological Conditions, Anatomical

Study Officials

• Qi Li, professor

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qi Li, professor

CONTACT

+8618623511778; qili_md@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 16, 2026

Record last verified: 2025-09

Locations

CN (6)