OPtimizing REperfusion by Intra-Arterial ThRomboLysis as Adjunct to Endovascular Treatment for Medium Vessel Occlusion (PEARL-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Combination product
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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 intra-arterial thrombolysis as adjunct to endovascular treatment in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset.

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

• 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 ≥6.

• 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.

Locations
Other Locations
China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Zhenhong Deng
dengzhh58@mail.sysu.edu.cn
86-20-81332619
Backup
Xinguang Yang
yangxinguang0926@163.com
86-20-81332619
Time Frame
Start Date: 2025-10-09
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 530
Treatments
Experimental: Intervention group
Intra-arterial thrombolysis as adjunct to endovascular treatment, in addition to standard medical treatment
Active_comparator: Control group
Only standard medical treatment
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

This content was sourced from clinicaltrials.gov