A prospective, multicenter, randomized controlled, open-label, blinded outcome evaluation (PROBE) trial
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
612
balloon dilatation and/or stenting immediately after randomization
medication after randomisation, mechanical thrombectomy again if necessary, avoiding balloon dilatation and/or stenting.
Functional recovery
defined as a sequence shift (improvement) in scores on the mRS
Time frame: 90(±14) days
Rate of good functional outcome
mRS of 0-2
Time frame: 90 (±14) days
Rate of excellent functional outcome
mRS 0-1
Time frame: 90(±14) days
Change in stroke severity (NIHSS score)
Time frame: 24±12 hours
Change in stroke severity (NIHSS score)
Time frame: 7±2 days or discharge
Proportion of target vessel recanalisation (eTICI≥2b)
Time frame: 5±2 days
Final infarct volume
Time frame: 5±2 days
EuroQol Five Dimensions (EQ-5D) Score
Time frame: 90 (±14) days
Barthel Index
Time frame: 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
mRS 3-6 at 90 days; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 90 days and 365 days
Time frame: 365days
Stroke
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Time frame: between 90 days and 365 days
mRS Score shift
Time frame: 365 (±30)days
Rate of good functional outcome
mRS of 0-2
Time frame: 365 (±30) days
Rate of excellent functional outcome
mRS of 0-1
Time frame: 365 (±30) days
EuroQol Five Dimensions (EQ-5D) Score
Time frame: 365 (±30) days
Barthel Index
Time frame: 365 (±30) days