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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; AIS; ICAS - Intracranial Atherosclerosis
• Intervention / Treatment: Device: balloon dilatation and/or stenting; Drug: medication

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 Type: Interventional
• Enrollment (Estimated): 612
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pengfei Yang, MD, PhD; Phone Number: 86-21-31161784; Email: 15921196312@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	Device: balloon dilatation and/or stenting; balloon dilatation and/or stenting immediately after randomization
Active Comparator: Control group	Drug: medication; medication after randomisation, mechanical thrombectomy again if necessary, avoiding balloon dilatation and/or stenting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional recovery	defined as a sequence shift (improvement) in scores on the mRS	90(±14) days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stroke severity (NIHSS score)		24±12 hours
Change in stroke severity (NIHSS score)		7±2 days or discharge
Final infarct volume		5±2 days
EuroQol Five Dimensions (EQ-5D) Score		90 (±14) days
Barthel Index		90 (±14) days
Rate of good functional outcome	mRS of 0-2	90 (±14) days
Rate of excellent functional outcome	mRS 0-1	90(±14) days
Proportion of target vessel recanalisation (eTICI≥2b)		5±2 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	365days
Stroke		between 90 days and 365 days
mRS Score shift		365 (±30)days
Rate of good functional outcome	mRS of 0-2	365 (±30) days
Rate of excellent functional outcome	mRS of 0-1	365 (±30) days
EuroQol Five Dimensions (EQ-5D) Score		365 (±30) days
Barthel Index		365 (±30) days

Other Outcome Measures

Outcome Measure	Time Frame
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	Perioperative period
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

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: The First People's Hospital of Changzhou
• Investigators: Principal Investigator: Jianmin Liu, MD, PhD, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): August 15, 2027

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: AIS; STROKE; ICAS
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Atherosclerosis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents; Tirofiban; Platelet Aggregation Inhibitors
• Other Study ID Numbers: ICAS LVO-MT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
• IPD Sharing Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• IPD Sharing Access Criteria: The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered.; The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials.; Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research.; Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection.; The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No