Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO)

Army Medical University

Status and phase: Not yet enrolling; Phase 3

Conditions: Acute Ischemic Stroke

Treatments: Procedure: Intra-arterial thrombolysis; Other: Standard medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07469293

2025.8.10V1.0

Details and patient eligibility

About

DATE-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of tenecteplase combined with standard medications in acute ischemic stroke patients with medium vessel occlusion stroke within 24 hours of onset.

Enrollment: 488 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old
2. Acute isolated intracranial medium vessel occlusion (Distal middle cerebral artery M2; M3 and M4 segments of the middle cerebral artery; A1-A4 segments of the anterior cerebral artery; P1-P3 segments of the posterior cerebral artery), confirmed by imaging, with symptom onset to randomization within 24 hours;
3. NlHSS score ≥ 5
4. CT scan performed within 24 hours confirming that the ischemic lesion does not involve more than one-third of the territory supplied by the responsible vessel (no evidence of early large infarction)
5. Patients with premorbid mRS 0 or 1
6. Written informed consent obtained from the participant or a legally authorized representative

Exclusion criteria

1. Intracranial hemorrhage confirmed by cranial CT or MRI;
2. Already received intravenous thrombolysis;
3. Planned mechanical thrombectomy;
4. Intraoperative DSA showing vessel rupture, dissection, or contrast agent extravasation;
5. Pregnant or breastfeeding women;
6. Allergy to contrast agents or tenecteplase;
7. Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and failure to control with oral antihypertensive medications;
8. Genetic or acquired bleeding disorders, coagulation factor deficiencies; coagulation dysfunction, INR > 1.7, or use of novel oral anticoagulants within 48 hours;
9. Blood glucose < 2.8 mmol/L (50 mg/dL) or > 22.2 mmol/L (400 mg/dL), platelet count < 100 × 10^9/L;
10. History of bleeding within the past month (gastrointestinal or urinary tract bleeding);
11. Chronic hemodialysis or severe renal insufficiency (glomerular filtration rate < 30 mL/min or serum creatinine > 220 μmol/L (2.5 mg/dL));
12. Severe mental disorders or inability to provide informed consent and comply with follow-up due to dementia;
13. Concurrent malignant tumors or severe systemic diseases with an expected survival time of less than 90 days;
14. Intracranial aneurysms or arteriovenous malformations;
15. Participation in another clinical interventional trial within 30 days prior to randomization or currently participating in another clinical interventional trial;
16. Occlusions in multiple vascular territories confirmed by CTA/MRA;
17. Other reasons that the investigator deems inappropriate for participation in the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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488 participants in 2 patient groups

TNK intra-arterial thrombolysis group

Experimental group

Description:

Intra-arterial thrombolysis

Treatment:

Procedure: Intra-arterial thrombolysis

Standard medical therapy group

Active Comparator group

Description:

Only standard medical therapy

Treatment:

Other: Standard medical treatment