OPtimizing REperfusion by Intra-Arterial ThRomboLysis as Adjunct to Endovascular Treatment for Me… (NCT07137832) | Clinical Trial Compass
RecruitingPhase 3
OPtimizing REperfusion by Intra-Arterial ThRomboLysis as Adjunct to Endovascular Treatment for Medium Vessel Occlusion
China530 participantsStarted 2025-10-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. Evidence of intracranial hemorrhage.
✕. Pre-stroke mRS score ≥ 2.
✕. Rapidly improving symptoms, in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of \<6 at randomization.
✕. The intervention procedure is unlikely to be completed as assessed by the investigator.
✕. Suspected cerebral vasculitis, septic embolization, or vascular occlusion due to infective endocarditis.
What they're measuring
1
The modified Rankin Scale score (mRS) 0-1
Timeframe: 90 (±14) days
Trial details
NCT IDNCT07137832
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University