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 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07323368
Eligibility Criteria:
Inclusion Criteria:
* Age≥18 years old;
* Acute ischemic stroke symptom onset within 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";
* Primary medium vessel occlusions confirmed by CTA/MRA, including non-dominant proximal M2 or mid-distal M2/M3 segments of the middle cerebral artery (MCA), A1/A2/A3 segments of the anterior cerebral artery (ACA), and P1/P2/P3 segments of the posterior cerebral artery (PCA) and responsible for the signs and symptoms of acute ischemic stroke;
* Pre-stroke modified Rankin scale (mRS) score ≤1;
* Baseline National Institutes of Health Stroke Scale (NIHSS) ≥8;
* Neuroimaging criteria: Target mismatch profile on CT perfusion or MRI+MR perfusion (ischemic core volume \<70 mL, mismatch rate \>1.2, mismatch volume \>10 mL);
* Written informed consent from patients or their legally authorized representatives.
Exclusion Criteria:
* Any evidence of intracranial hemorrhage on qualifying imaging;
* Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys and unable to complete CTP/PWI;
* Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the arterial access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after EVT;
* Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma);
* Clinical diagnosis of cerebral vasculitis;
* Evidence of vessel recanalization prior to randomisation;
* Severe comorbidities, which will likely prevent improvement or follow-up;
* Any terminal illness such that the patient would not be expected to survive more than 1 year;
* Hypodensity in \>1/3 MCA territory on non-contrast CT or significant hypodensity outside the current perfusion lesion suggesting distal clot migration (secondary MeVO);
* Multiple arterial occlusion;
* Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of the trial;
* Unlikely to adhere to the trial protocol or follow-up;
* Participation in other interventional clinical trials within the previous 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07323368
Study Brief:
Protocol Section:
NCT07323368