Clinical trial NCT06702657: A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy
Official title: A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy (ICAS LVO-MT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: AIS
ICAS - Intracranial Atherosclerosis
Stroke
Keywords: ICAS
AIS
STROKE
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: The First People's Hospital of Changzhou
First posted: 2024-11-25
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

Clinical inclusion criteria:

1. Age ≥ 18 years
2. National Institutes of Health Stroke Scale (NIHSS) score ≥6 before randomization
3. To receive mechanical thrombectomy \<24 hours after AIS onset according to local guidelines
4. Signed informed consent form obtained from the subject (or approved surrogate)

Imaging inclusion criteria:

1. For subjects with anterior circulation stroke, ASPECTS ≥6 based on CT or DWI
2. For subjects with posterior circulation stroke, posterior circulation ASPECTS (pc-ASPECTS)≥6 and pons-midbrains index (PMI) \< 3 based on CT or DWI

Angiography inclusion criteria:

1. 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
2. According to the judgment of the neurointerventional physician, the responsible artery is suitable for stenting angioplasty

Exclusion Criteria:

1. Pre-stroke mRS \>2
2. Intracranial hemorrhage confirmed by CT before mechanical thrombectomy and enrolment
3. Suspected Intracranial hemorrhage after successful recanalization confirmed by 3D-CT
4. 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
5. More than two severe stenosis of the responsible occluded vessel (internal carotid artery, middle cerebral artery, vertebral artery, and basilar artery)
6. Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc.
7. Current use of oral anticoagulants
8. Major surgery or serious trauma in the previous 2 weeks
9. Contraindication for mechanical thrombectomy or stenting angioplasty
10. Contraindication for antiplatelet treatment or allergy to contrast agent
11. History of gastrointestinal or urinary bleeding in the previous 3 weeks
12. Life expectancy less than 1 years
13. Current pregnant or breastfeeding status
14. Currently participating in another clinical trial that may affect the outcome assessment of this trial
15. Any other condition that, in the investigator's judgement, deems the individual unsuitable for enrolment.

Primary outcomes:
measure: Functional recovery
timeFrame: 90(±14) days
Secondary outcomes:
measure: Rate of good functional outcome
timeFrame: 90 (±14) days
measure: Rate of excellent functional outcome
timeFrame: 90(±14) days
measure: Change in stroke severity (NIHSS score)
timeFrame: 24±12 hours
measure: Change in stroke severity (NIHSS score)
timeFrame: 7±2 days or discharge
measure: Proportion of target vessel recanalisation (eTICI≥2b)
timeFrame: 5±2 days
measure: Final infarct volume
timeFrame: 5±2 days
measure: EuroQol Five Dimensions (EQ-5D) Score
timeFrame: 90 (±14) days
measure: Barthel Index
timeFrame: 90 (±14) days
measure: mRS 3-6 at 90 days; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 90 days and 365 days
timeFrame: 365days
measure: Stroke
timeFrame: between 90 days and 365 days
measure: mRS Score shift
timeFrame: 365 (±30)days
measure: Rate of good functional outcome
timeFrame: 365 (±30) days
measure: Rate of excellent functional outcome
timeFrame: 365 (±30) days
measure: EuroQol Five Dimensions (EQ-5D) Score
timeFrame: 365 (±30) days
measure: Barthel Index
timeFrame: 365 (±30) days
Other outcomes:
measure: Deaths
timeFrame: within 90±14 days after enrolment
measure: Intracranial hemorrhage
timeFrame: at 7 days post treatment or discharge (whichever occurs first)
measure: SAEs
timeFrame: within 90±14 days after enrolment
measure: Any procedural complications
timeFrame: Perioperative period
measure: The occurrence of new ischaemic stroke in the downstream territory of the occluded vessel
timeFrame: within 90±14 days after enrolment
measure: Any cause of death
timeFrame: within 365±30 days after enrolment
measure: Any occurrence of intracranial hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
timeFrame: within 365±30 days after enrolment
Locations:
Study officials:
affiliation: Changhai Hospital
name: Jianmin Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: