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:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT06702657
Eligibility Criteria:
Inclusion Criteria:
Clinical inclusion criteria:
1. Age ≥ 18 years
2. National Institutes of Health Stroke Scale (NIHSS) score ≥6 before randomization
3. To receive mechanical thrombectomy \<24 hours after AIS onset according to local guidelines
4. Signed informed consent form obtained from the subject (or approved surrogate)
Imaging inclusion criteria:
1. For subjects with anterior circulation stroke, ASPECTS ≥6 based on CT or DWI
2. For subjects with posterior circulation stroke, posterior circulation ASPECTS (pc-ASPECTS)≥6 and pons-midbrains index (PMI) \< 3 based on CT or DWI
Angiography inclusion criteria:
1. The responsible occluded vessel is immediately recanalized (eTICI≥2b) after mechanical thrombectomy, ICAS is highly suspected and the focal residual stenosis of the main trunk is≥70%, and the responsible occluded vessels include the intracranial segment of the internal carotid artery, the M1 segment of the middle cerebral artery, the V4 segment of the vertebral artery, and the basilar artery
2. According to the judgment of the neurointerventional physician, the responsible artery is suitable for stenting angioplasty
Exclusion Criteria:
1. Pre-stroke mRS \>2
2. Intracranial hemorrhage confirmed by CT before mechanical thrombectomy and enrolment
3. Suspected Intracranial hemorrhage after successful recanalization confirmed by 3D-CT
4. Tandem lesions: stenosis (or occlusion) of the extracranial segment of the internal carotid artery or vertebral artery combined with occlusion of large intracranial vessels, stenosis of intracranial arteries combined with occlusion of vessels distal to the stenosis
5. More than two severe stenosis of the responsible occluded vessel (internal carotid artery, middle cerebral artery, vertebral artery, and basilar artery)
6. Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc.
7. Current use of oral anticoagulants
8. Major surgery or serious trauma in the previous 2 weeks
9. Contraindication for mechanical thrombectomy or stenting angioplasty
10. Contraindication for antiplatelet treatment or allergy to contrast agent
11. History of gastrointestinal or urinary bleeding in the previous 3 weeks
12. Life expectancy less than 1 years
13. Current pregnant or breastfeeding status
14. Currently participating in another clinical trial that may affect the outcome assessment of this trial
15. Any other condition that, in the investigator's judgement, deems the individual unsuitable for enrolment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06702657
Study Brief:
Protocol Section:
NCT06702657