Not Yet RecruitingNot Applicable

A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy

612 participantsStarted 2025-03-15

Plain-language summary

A prospective, multicenter, randomized controlled, open-label, blinded outcome evaluation (PROBE) trial

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years
✓. National Institutes of Health Stroke Scale (NIHSS) score ≥6 before randomization
✓. To receive mechanical thrombectomy \<24 hours after AIS onset according to local guidelines
✓. Signed informed consent form obtained from the subject (or approved surrogate)
✓. For subjects with anterior circulation stroke, ASPECTS ≥6 based on CT or DWI
✓. For subjects with posterior circulation stroke, posterior circulation ASPECTS (pc-ASPECTS)≥6 and pons-midbrains index (PMI) \< 3 based on CT or DWI
✓. 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
✓. According to the judgment of the neurointerventional physician, the responsible artery is suitable for stenting angioplasty

✕. Pre-stroke mRS \>2
✕. Intracranial hemorrhage confirmed by CT before mechanical thrombectomy and enrolment
✕. Suspected Intracranial hemorrhage after successful recanalization confirmed by 3D-CT
✕. 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
✕. More than two severe stenosis of the responsible occluded vessel (internal carotid artery, middle cerebral artery, vertebral artery, and basilar artery)
✕. Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc.
✕. Current use of oral anticoagulants
✕. Major surgery or serious trauma in the previous 2 weeks

Functional recovery

Timeframe: 90(±14) days

NCT IDNCT06702657

SponsorChanghai Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-15

Pengfei Yang, MD, PhD

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years
✓. National Institutes of Health Stroke Scale (NIHSS) score ≥6 before randomization
✓. To receive mechanical thrombectomy \<24 hours after AIS onset according to local guidelines
✓. Signed informed consent form obtained from the subject (or approved surrogate)
✓. For subjects with anterior circulation stroke, ASPECTS ≥6 based on CT or DWI
✓. For subjects with posterior circulation stroke, posterior circulation ASPECTS (pc-ASPECTS)≥6 and pons-midbrains index (PMI) \< 3 based on CT or DWI
✓. 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
✓. According to the judgment of the neurointerventional physician, the responsible artery is suitable for stenting angioplasty

✕. Pre-stroke mRS \>2
✕. Intracranial hemorrhage confirmed by CT before mechanical thrombectomy and enrolment
✕. Suspected Intracranial hemorrhage after successful recanalization confirmed by 3D-CT
✕. 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
✕. More than two severe stenosis of the responsible occluded vessel (internal carotid artery, middle cerebral artery, vertebral artery, and basilar artery)
✕. Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc.
✕. Current use of oral anticoagulants
✕. Major surgery or serious trauma in the previous 2 weeks