A Phase 2/3 interventional study of Intra-arterial Thrombolysis and Standard medical treatment in Acute Ischemic Stroke and Medium Vessel Occlusion, sponsored by Xiang Luo. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Xiang Luo · Phase 2/3, Interventional, and Treatment
Medium vessel occlusion (MeVO) accounts for 20-45% of acute ischemic stroke (AIS). Although patients with MeVO often present with relatively low NIHSS scores, up to one-third remain functionally dependent at follow-up despite receiving standard medical therapy, including intravenous thrombolysis. Recent randomized trials (DISTAL, ESCAPE-MeVO, DISCOUNT) have not demonstrated clinical benefit of endovascular treatment (EVT) for MeVO and have suggested higher risks of symptomatic intracranial hemorrhage and mortality, underscoring the need for safer and more targeted reperfusion strategies.
Intra-arterial thrombolysis (IAT) enables localized, high-concentration thrombolytic delivery with minimal mechanical manipulation, which may be advantageous for medium and distal vessels. Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA), a genetically engineered third-generation thrombolytic agent, has shown favorable pharmacologic properties and clinical safety in AIS, including in intra-arterial use following EVT. However, prospective evidence supporting its direct therapeutic role in MeVO-related AIS remains lacking.
This multicenter, prospective, open-label randomized controlled trial with blinded endpoint assessment is designed to evaluate the efficacy and safety of intra-arterial rhTNK-tPA thrombolysis in improving functional outcome in MeVO within 24 hours of symptom onset.
This study is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) clinical trial designed to evaluate the efficacy and safety of intra-arterial rhTNK-tPA in improving 90-day functional outcomes in patients with MeVO stroke within 24 hours of symptom onset. The primary outcome is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-1 at 90 days. Eligible patients will be randomized in a 1:1 ratio to receive either intra-arterial rhTNK-tPA thrombolysis (0.125 mg/kg, Max 12.5mg) plus standard medical therapy or standard medical therapy alone. A total of 382 participants (191 per group) will be enrolled in this trial.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's planned enrollment of 382 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Xiang Luo is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Acute ischemic stroke within 6-24 hours of onset, meeting at least one of the following imaging criteria:
Exclusion Criteria:
Patients of this group will receive intra-arterial rhTNK-tPA thrombolysis plus standard medical treatment
Procedure: Intra-arterial Thrombolysis · Drug: Standard medical treatment
Patients of this group will receive standard medical treatment alone
Drug: Standard medical treatment
rhTNK-tPA（Tenecteplase）dose: 0.125 mg/kg, maximum dose: 12.5mg.
Standard medical treatment
Excellent outcome
Rate of modified Rankin scale (mRS) 0-1 at 90±7 days
Time frame: 90±7 days
Ordinal distribution of mRS
The shift analysis of mRS at 90±7 days (mRS 5 and 6 merged)
Time frame: 90±7 days
Functional independence
Rate of mRS 0-2 at 90±7 days
Time frame: 90±7 days
Quality of life (EQ-5D-5L)
The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score at 90±7 days The EQ-5D-5L is a standardized, preference-based measure of health-related quality of life covering five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five severity levels. The EQ-5D-5L index score typically ranges from less than 0 (health states worse than death) to 1.0 (full health), with higher scores indicating better quality of life.
Time frame: 90±7 days
Neurologic deficit (NIHSS score) changes
The change of the National Institutes of Health Stroke Scale (NIHSS) score from baseline to 36±12 hours The NIHSS is a standardized clinical scale used to quantify neurologic impairment in stroke patients. The total score ranges from 0 to 42, with higher scores indicating more severe neurologic deficit. The outcome is defined as the change in NIHSS score from baseline, where a greater negative change reflects greater neurologic improvement.
Time frame: 36±12 hours
Infarct core volume change from baseline
Infarct core volume change from baseline at 7±1 days or discharge if earlier
Time frame: 7±1 days or discharge if earlier
Symptomatic intracranial hemorrhage (sICH)
Rate of sICH within 48 hours after randomization (Heidelberg Bleeding Classification)
Time frame: 48 hours
All-caused mortality
All cause mortality at 90±7 days
Time frame: 90±7 days
Any intracranial hemorrhage
Rate of any intracranial hemorrhage within 48 hours after randomization (Heidelberg Bleeding Classification)
Time frame: 48 hours
Plan to share: No
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