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 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07389460
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years;
2. Acute ischemic stroke presenting within 4.5-24 hours of last known well;
3. No significant pre-stroke functional disability: for age \<80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;
4. Baseline NIHSS score ≥6;
5. Imaging criteria of BOTH:
1\. Occlusion on CTA/MRA in one of the following vessels: M1/M2 segment of middle cerebral artery, A1 segment of anterior cerebral artery, V4 segment of vertebral artery, basilar artery, or P1 segment of posterior cerebral artery. For A1, or P1 occlusions, vessel diameter must be ≥0.75 mm; 2. For anterior circulation occlusion: CTP/MRP demonstrating mismatch ratio ≥1.8, absolute mismatch volume ≥15 mL, and ischemic core volume \<70 mL; OR have a mismatch between the presence of an abnormal signal on MRI diffusion-weighted imaging and no visible signal change on FLAIR. For posterior circulation occlusion: pc-ASPECTS score ≥6.
6\. Plan to received endovascular thrombectomy; 7. The patient or their legal representative provides written informed consent.
Exclusion Criteria:
1. Intracranial hemorrhage confirmed by CT/MRI;
2. Onset accompanied by epileptic seizures, resulting in questionable stroke diagnosis and inability to obtain an accurate baseline NIHSS score;
3. Women who are pregnant or breastfeeding, or have a positive serum β-HCG test upon admission;
4. Already received intravenous thrombolytic after index stroke;
5. History of prior intracranial hemorrhage, including cerebral parenchymal hemorrhage, subarachnoid hemorrhage, and subdural/extradural hematoma;
6. Active bleeding or bleeding tendency, such as gastrointestinal bleeding, urinary tract bleeding, retinal hemorrhage, etc., or presence of coagulation dysfunction;
7. History of major recent surgery or trauma, such as intracranial or spinal surgery within the past 3 months, major surgery within the past 2 weeks, or severe head trauma within the past 3 weeks;
8. Baseline blood glucose \<2.8 mmol/L or \>22.2 mmol/L;
9. Received low molecular weight heparin within 24 hours, or oral anticoagulants with an International Normalized Ratio (INR) \>1.7, or thrombin inhibitors within 48 hours, among others;
10. Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel;
11. Pre-existing neurological/psychiatric disorders interfering with neurological assessment;
12. Space-occupying intracranial tumors (except for small meningiomas);
13. Intracranial aneurysm or arteriovenous malformation;
14. Terminal illness with life expectancy \<6 months;
15. Concurrent participation in other investigation clinical trials;
16. Presence of other conditions deemed by the investigator as unsuitable for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07389460
Study Brief:
Protocol Section:
NCT07389460