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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Fu Yang People's Hospital
RECRUITING
Fuyang
Lin Quan People's Hospital
RECRUITING
Fuyang
The Second (Affiliated) Hospital of Anhui Medical University
RECRUITING
Hefei
Lishui Central Hospital
RECRUITING
Lishui
LiuZhou Worker's Hospital
RECRUITING
Liuchow
Shucheng People's Hospital
RECRUITING
Lu'an
Contact Information
Primary
Qi Li, professor
qili_md@126.com
+8618623511778
Time Frame
Start Date: 2026-01-06
Estimated Completion Date: 2030-05-01
Participants
Target number of participants: 282
Treatments
Experimental: Intra-arterial Thrombolysis plus Best Medical Treatment
Patients in this group will receive intra-arterial thrombolysis plus best medical treatment.
Other: Best Medical Treatment
Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.
Related Therapeutic Areas
Sponsors
Leads: The Second Hospital of Anhui Medical University

This content was sourced from clinicaltrials.gov

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