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ClinicalTrials.gov ID

NCT07469293

Lead Sponsor

Southwest Hospital, ChinaOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

488Estimated

Last Update Posted

Mar 20, 2026Actual

Start Date

Mar 25, 2026Estimated

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

Official Title

Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial

Brief Summary

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.

• Acute Ischemic Stroke

• Intra-arterial thrombolysis
• Standard medical treatment

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Southwest Hospital, ChinaOTHER

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