A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy

NCT06702657 | Not Yet Recruiting DMC

• 1 other identifier: ICAS LVO-MT
• Study Type: interventional
• Target: 612
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

AIS; ICAS - Intracranial Atherosclerosis; Stroke

Keywords

ICAS; AIS; STROKE

Outcome Measures

Primary Outcomes (1)

• Functional recovery

  defined as a sequence shift (improvement) in scores on the mRS

  90(±14) days

Secondary Outcomes (15)

• Rate of good functional outcome

  90 (±14) days

• Rate of excellent functional outcome

  90(±14) days

• Change in stroke severity (NIHSS score)

  24±12 hours

• Change in stroke severity (NIHSS score)

  7±2 days or discharge

• Proportion of target vessel recanalisation (eTICI≥2b)

  5±2 days

Other Outcomes (7)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Device: balloon dilatation and/or stenting

Control group

ACTIVE COMPARATOR

Drug: medication

Interventions

balloon dilatation and/or stenting DEVICE

balloon dilatation and/or stenting immediately after randomization

Intervention group

medication DRUG

medication after randomisation, mechanical thrombectomy again if necessary, avoiding balloon dilatation and/or stenting.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• National Institutes of Health Stroke Scale (NIHSS) score ≥6 before randomization
• To receive mechanical thrombectomy \<24 hours after AIS onset according to local guidelines
• Signed informed consent form obtained from the subject (or approved surrogate)
• For subjects with anterior circulation stroke, ASPECTS ≥6 based on CT or DWI
• For subjects with posterior circulation stroke, posterior circulation ASPECTS (pc-ASPECTS)≥6 and pons-midbrains index (PMI) \< 3 based on CT or DWI
• 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
• According to the judgment of the neurointerventional physician, the responsible artery is suitable for stenting angioplasty

You may not qualify if:

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

Sponsors & Collaborators

• Changhai Hospital: lead
• The First People's Hospital of Changzhou: collaborator

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Stroke

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Jianmin Liu, MD, PhD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengfei Yang, MD, PhD

CONTACT

86-21-31161784; 15921196312@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: March 15, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): August 15, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• Access Criteria: 1. 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. 2. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. 3. 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. 4. 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. 5. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.