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 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07336927
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 y;
2. Diagnosed as acute ischemic stroke;
3. Isolated medium distal vessel occlusion (i.e. an occlusion of the M2, the M3/M4 segment of the MCA, the A1/ A2/A3 segment of the ACA or the P1/P2/P3 segment of the PCA) confirmed by CT or MR Angiography;
4. Time from onset (or last-seen-well) to randomization \< 24h;
5. Has not received intravenous thrombolysis and is considered unsuitable for it based on the treating clinician's assessment.
6. NIHSS ≥ 5, or NIHSS ≤ 4 with disabling deficit (e.g. severe aphasia, hemianopia, hemiplegia/loss of function in one side) or fluctuating symptoms at the time of randomization;
7. For patients within 6 h of onset: No visually apparent hypodensity is observed on non-contrast CT compared with the contralateral white matter, or no hyperintensity is seen on fluid-attenuated inversion recovery (FLAIR) imaging; For patients presenting 6-24 h after onset: A perfusion imaging-based ischemic core mismatch ratio \>1.2 and an infarct core volume \<50 mL are required;
8. Pre-stroke mRS ≤ 1；
9. Patient/Legally Authorized Representative has signed the Informed Consent form.
Exclusion Criteria:
1. Any evidence of intracranial hemorrhage on qualifying imaging;
2. Concurrent multiple (≥2) intracranial arterial occlusions;
3. Suspected cerebral vasculitis, septic embolism, or infective endocarditis as the cause of vessel occlusion;
4. Suspected arterial dissection;
5. Clinical assessment of conditions unsuitable for interventional therapy (e.g., severe contrast agent allergy or absolute contraindications to iodine contrast agent; severe renal insufficiency, glomerular filtration rate \< 30ml/min or serum creatinine \> 220μmol/L (2.5 mg/dl));
6. Unsuitable for arterial thrombolytic therapy (e.g., known history of hereditary or acquired hemorrhagic disease and/or platelet count \<50×109/L; abnormal coagulation function (INR\>1.7); oral anticoagulants were taken within 24 - 48 hours before onset within APTT \> 3 times normal; recent medical history or clinical manifestations of brain tumors other than meningiomas);
7. Any terminal disease with life expectancy \<1 year;
8. Pregnancy or lactation;
9. Concurrent participation in another investigational drug or device study that could interfere with the present trial;
10. Other circumstances that participation is not deemed appropriate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07336927
Study Brief:
Protocol Section:
NCT07336927