NCT06702657

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

A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy (ICAS LVO-MT)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 612 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The main objective of AIS ICAS-MT study is to evaluate whether direct stenting, compared with medical therapy can benefit patients with acute ischemic stroke caused by CTA-confirmed large vessel occlusion (intracranial segments ICA, M1, BA, V4) who have been successfully recanalized by mechanical thrombectomy (MT) and are judged to be in situ ICAS lesions. Primary outcomes: Functional recovery, defined as a sequence shift (improvement) in scores on the mRS at 90 (±14) days. Secondary outcomes: * Rate of good functional outcome (mRS of 0-2) at 90±14 days * Rate of excellent functional outcome (mRS of 0-1) at 90±14 days * Change in stroke severity (NIHSS score) at 24±12 hours * Change in stroke severity (NIHSS score) at 7±2 days or discharge * Proportion of target vessel recanalisation (eTICI≥2b) at 5±2 days confirmed by CTA * Final infarct volume at 5±2 days * EuroQol Five Dimensions (EQ-5D) Score at 90±14 days * Barthel Index at 90±14 days * mRS 3-6 at 90 days; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 90 days and 365 days * Stroke between 90 days and 365 days * mRS Score shift at 365±30 days as an ordinal variable * Rate of good functional outcome (mRS of 0-2) at 365±30 days * Rate of excellent functional outcome (mRS of 0-1) at 365±30 days * EuroQol Five Dimensions (EQ-5D) Score at 365±30 days * Barthel Index at 365±30 days Safety outcomes: * Deaths within 90±14 days after enrolment * Intracranial hemorrhage at 7 days post treatment or discharge (whichever occurs first) * SAEs within 90±14 days after enrolment * Any procedural complications * The occurrence of new ischaemic stroke in the downstream territory of the occluded vessel within 90±14 days after enrolment * Any cause of death within 365±30 days after enrolment * Any occurrence of intracranial hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage within 365±30 days after enrolment

Conditions

• AIS
• ICAS - Intracranial Atherosclerosis
• Stroke

Interventions

Type	Name	Description
DEVICE	balloon dilatation and/or stenting	balloon dilatation and/or stenting immediately after randomization
DRUG	medication	medication after randomisation, mechanical thrombectomy again if necessary, avoiding balloon dilatation and/or stenting.

Timeline

• Start date: 2025-03-15
• Primary completion: 2026-11-15
• Completion: 2027-08-15
• First posted: 2024-11-25
• Last updated: 2025-03-18