Not Yet RecruitingPhase 3

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

China306 participantsStarted 2026-07-01

Plain-language summary

Study purpose: A multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) phase III trial is planned to evaluate the efficacy and safety of intra-arterial thrombolysis (IAT) in patients with acute ischemic stroke caused by medium vessel occlusion (MeVO), compared with best medical management alone. Eligible participants (aged 18-80 years, baseline NIHSS score 6-25 or 3-5 with disabling deficits, confirmed MeVO within 24 hours of symptom onset) will be randomly assigned 1:1 to the intra-arterial thrombolysis plus best medical management group or the best medical management alone group. Primary endpoint: proportion of patients with favorable functional outcome (modified Rankin Scale score 0-2) at 90±7 days post-randomization. Secondary endpoints: 1. Recanalization rate (meTICI ≥ 2b) at 24±12 hours post-randomization; 2. Early neurological improvement (NIHSS score change from baseline) at 7±1 days or discharge; 3. Overall distribution of mRS scores at 90±7 days (shift analysis); 4. Excellent functional outcome (mRS score 0-1) at 90±7 days; 5. Health-related quality of life (EQ-5D-5L) at 90±7 days; 6. Functional independence (Barthel Index score 95-100) at 90±7 days; 7. Symptomatic intracranial hemorrhage (sICH) per Heidelberg criteria within 48 hours; 8. Early neurological deterioration (NIHSS increase ≥ 4 points or any single item increase ≥ 2 points) within 7 days; 9. Any intracranial hemorrhage within 48 hours; 10. Procedure-related complications; 11. All-cause mortality within 90±7 days.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

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: * Age 18 to 80 years. * Time from symptom onset or last known well to randomization within 24 hours. * Clinical diagnosis of acute ischemic stroke confirmed by CTA or MRA as being caused by isolated acute medium vessel occlusion, including distal M2/M3 segments of the middle cerebral artery, A2/A3 segments of the anterior cerebral artery, or P1/P2/P3 segments of the posterior cerebral artery. Isolated occlusion is defined as a single symptomatic vessel occlusion; patients with multiple vessel occlusions or uncertain culprit vessel are excluded. * Baseline NIHSS score ≥ 6, or 3-5 with disabling deficits (e.g., motor weakness, aphasia, visual field defects), and NIHSS score ≤ 25 at the time of randomization. * For patients presenting beyond 6 hours from symptom onset: perfusion imaging criteria require Tmax \> 6s volume ≥ 10 cc, and core infarct volume (defined as rCBF \< 30%) less than 50% of the Tmax \> 6s volume. * Patient or legally authorized representative is able to understand and voluntarily sign the informed consent form. Exclusion Criteria: * Clinical Exclusion Criteria: * Pre-stroke modified Rankin Scale (mRS) score \> 2. * Presence of contraindications to intravenous thrombolysis. * Known allergy to heparin, contrast media, anesthetics, or other definite contraindications to endovascular treatment. * Comorbid severe diseases that may affect outcome assessment, including but not limited to malignancy, severe heart failure, or renal failure, wit…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients with favorable functional outcome at 90 days

Timeframe: 90 days post-randomization (90±7 days)

Trial details

NCT IDNCT07668323

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-30

Contact for this trial

Xinglong Liu, Doctor

+8618262638087 plear_new@163.com

View on ClinicalTrials.gov More Medium Vessel Occlusion trials