Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
Study NCT ID:
NCT06702657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-18
First Post:
2024-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy
Sponsor:
Changhai Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICAS LVO-MT
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: