Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07469293
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT07469293
Study Brief:
Protocol Section:
NCT07469293