Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT06702657
Brief 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
Study:
NCT06702657
Study Brief:
Protocol Section:
NCT06702657