Tenecteplase delivered into the artery for acute medium-vessel stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ANGEL-MeVO-TNK is a multicenter, randomized, open-label, blinded-endpoint phase III trial enrolling 488 adults with acute medium-vessel occlusion ischemic stroke within 24 hours. Participants are randomized 1:1 to intra-arterial tenecteplase given by slow, super-selective infusion during angiography (initial 0.0625 mg/kg over 15 minutes with a possible repeat dose) or to standard medical management. Outcome assessors are blinded to treatment allocation, and key eligibility includes limited infarct size on imaging, pre-stroke functional independence, and a baseline NIHSS indicating moderate or disabling deficits. The trial measures whether intra-arterial tenecteplase improves artery reopening and functional outcomes compared with usual care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Clinical Inclusion Criteria:

1. Age ≥18 years;
2. Pre-stroke mRS 0-1;
3. Within 24 h from symptom onset;
4. Baseline National Institutes of Health Stroke Scale (NIHSS) score \>5 or baseline NIHSS 3-5 with disabling deficit (e.g., loss of hand function, aphasia, hemianopia);
5. Informed consent obtained from patients or their legal representatives.

Imaging Inclusion Criteria:

1. Baseline CTA/MRA/DSA diagnosed isolated MeVO, referring to the M2/M3 segment of the MCA, the A1/A2/A3 segment of the ACA, the P1/P2/P3 segment of the PCA;
2. NCCT or MRI DWI imaging showing that the territory of the ischemic infarct volume is less than 50% of the estimated territory supplied by the occluded artery.

Exclusion Criteria:

1. Acute intracranial hemorrhage;
2. ASPECT ≤5;
3. MeVO secondary to spontaneous fragmentation and distal migration of thrombus from an acute large vessel occlusion, or occurring after intravenous thrombolysis (IVT), intra-arterial thrombolysis, or endovascular thrombectomy;
4. Contraindication to TNK;
5. Known severe allergy to contrast agents (excluding mild rash-type allergic reactions);
6. Use of heparin or novel oral anticoagulants within the previous 48 hours with an INR ≥ 1.7;
7. A history of major bleeding within the past 6 months or the presence of conditions such as active gastrointestinal ulcer, aortic dissection, platelet count \< 100 × 10⁹/L, etc.;
8. Radiologically confirmed vascular malformations, arterial dissection, intracranial aneurysm (diameter≥3 mm), tumors (except small meningiomas), cerebral vasculitis, cerebral amyloid angiopathy, or other major non-ischemic intracranial diseases (e.g., multiple sclerosis);
9. Acute renal failure, current dialysis, or estimated glomerular filtration rate (eGFR)\<30ml/min/1.72m2, and/or serum creatinine\>220mmol/L (2.5mg/dl);
10. History of severe liver disease, or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or glutamyl transferase (GGT) ≥3×upper limit of normal value (ULN) and/or total bilirubin (TBIL) ≥2×ULN;
11. Severe non-cardiovascular comorbidity with an expected life expectancy of less than 3 months (e.g., malignant tumors);
12. Known pregnancy or breastfeeding, or a positive pregnancy test prior to randomization;
13. Current participation in another drug or device clinical trial;
14. Any other condition deemed by the investigator to make the patient unsuitable for participation in the study or to pose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric illness, cognitive impairment, or emotional disorders).

Where it's running

• Beijing Tiantan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Liping Liu
• Email: lipingsister@gmail.com
• Phone: +86-010-59978328

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Theta Burst Stimulation to Help Stroke Recovery (Upper and Lower Limbs)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.