Actively Recruiting
Intra-arterial Recombinant Human Tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) Thrombolysis for Acute Medium Vessel Occlusion
Led by Xiang Luo · Updated on 2026-01-21
382
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intra-arterial Recombinant Human Tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) Thrombolysis for Acute Medium Vessel Occlusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pre-stroke modified Rankin Scale score of 0 or 1
- Baseline NIH Stroke Scale score of 4 or greater, or symptoms clearly disabling to the physician (e.g., hemianopia, aphasia, motor dysfunction)
- Confirmed isolated medium distal vessel occlusion by CT or MR angiography
- Acute ischemic stroke within 24 hours of symptom onset, including wake-up or unwitnessed strokes
- For strokes 6 to 24 hours old, meet imaging criteria for hypoperfusion-ischemic core mismatch or diffusion-hyperintensity mismatch
- Ability of participant or legal representative to provide informed consent
You will not qualify if you...
- Evidence of intracranial hemorrhage
- Active bleeding or recent surgery/biopsy within 30 days; severe head trauma or stroke within 3 months
- Persistent uncontrolled high blood pressure (systolic >185 mmHg or diastolic >110 mmHg)
- Inherited/acquired bleeding disorders or oral anticoagulant use with INR >1.7
- Blood glucose below 2.8 mmol/L or above 22.2 mmol/L, low platelet count, or low hemoglobin
- Severe liver failure, chronic dialysis, or severe kidney failure
- Pregnancy or breastfeeding
- Allergy to rhTNK-tPA or radiocontrast agents
- Participation in other clinical trials
- Expected survival less than 6 months due to serious illness
- Other conditions making participation unsafe or unsuitable per investigator judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
X
Xiang Luo, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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