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

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.

Conditions

• Medium Vessel Occlusion
• Ischemic Stroke, Acute

Interventions

DRUG

rt-PA; Recombinant Tissue Plasminogen Activator

Administered intra-arterially via microcatheter. Agent options: alteplase (rt-PA) at 0.225 mg/kg (maximum 22.5 mg) or tenecteplase (TNK) at 0.0625 mg/kg (maximum 6.25 mg), infused over 15-30 minutes. The choice of agent should be consistent with any prior intravenous thrombolysis.

PROCEDURE

Intra-arterial Thrombolysis

Microcatheter is navigated to the occluded medium vessel. For small thrombus burden, positioned adjacent to or within the thrombus. For larger burden, advanced through occluded segment with staged administration distal-to-proximal (one-third per segment). Procedure ends at meTICI ≥ 2b or when risks outweigh benefits.

DRUG

Best Medical Management

Best medical management per local guidelines, including antiplatelet therapy, anticoagulation (if indicated), statins, blood pressure and glycemic control, and rehabilitation.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Principal Investigators

• Sheng Liu, Professor · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2028-07-30

Completion

2029-08-31

Countries

• China

Study Locations