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:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT07196605
Eligibility Criteria:
Inclusion Criteria:
1. Symptoms and signs consistent with focal ischemia in the anterior or posterior circulation;
2. Large vessel occlusion of the anterior or posterior circulation (internal carotid artery, M1/M2 segment of the middle cerebral artery, vertebral artery, or basilar artery) confirmed by CTA/MRA/DSA;
3. Undergoing mechanical thrombectomy;
4. Age ≥18 years, both male and female;
5. Pre-stroke modified Rankin Scale (mRS) score ≤1;
6. Time from symptom onset to thrombectomy ≤24 hours, including wake-up stroke or unwitnessed stroke; symptom onset is defined as the "last known well" (LKW);
7. National Institutes of Health Stroke Scale (NIHSS) score ≥6 at admission;
8. ASPECTS ≥3 for anterior circulation occlusion, or pc-ASPECTS ≥6 for posterior circulation occlusion;
9. Written informed consent provided by the patient or their legal representative.
Exclusion Criteria:
1. Simultaneous acute occlusion of both anterior and posterior circulation or bilateral hemispheric large vessel occlusions;
2. Complete clinical recovery at the end of EVT procedure;
3. Arterial dissection or intraoperative hemorrhage indicated by post-thrombectomy DSA;
4. Sedated and intubated patients without baseline NIHSS assessment;
5. Seizure at stroke onset interfering with baseline NIHSS assessment;
6. Bilateral fixed dilated pupils;
7. Severe allergy or absolute contraindication to sodium sivelestat;
8. Severe allergy or absolute contraindication to iodinated contrast agents;
9. Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, uncontrolled despite antihypertensive therapy;
10. Blood glucose \<50 mg/dl (2.8 mmol/L) or \>400 mg/dl (22.2 mmol/L);
11. Platelet count \<50×10⁹/L;
12. Congenital or acquired bleeding diathesis, coagulation factor deficiency, or current use of oral anticoagulants with INR \>1.7;
13. Severe renal impairment, defined as serum creatinine \>3.0 mg/dl (265.2 μmol/L), GFR \<30 ml/min, or requirement for hemodialysis/peritoneal dialysis;
14. Inability to complete 90-day follow-up (e.g., no fixed residence, overseas patient);
15. Suspected vasculitis or septic embolism;
16. Suspected aortic dissection;
17. Pre-existing neurological or psychiatric disorders interfering with stroke assessment;
18. Pregnancy or lactation;
19. Confirmed rheumatic/autoimmune disease with long-term use of immunosuppressants or corticosteroids;
20. Current treatment with chemotherapy or other immunomodulatory agents (e.g., recombinant human granulocyte colony-stimulating factor, Xuebijing, ulinastatin, etc.);
21. Participation in another clinical trial that may interfere with study outcomes;
22. Any other condition that investigators deem unsuitable for participation or that may pose significant risk to the patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07196605
Study Brief:
Protocol Section:
NCT07196605