Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis
MAGIC
1 other identifier
interventional
412
1 country
2
Brief Summary
A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial that aims to evaluate the effect of immediate angioplasty (with or without stenting) for acute ischemic stroke (AIS) with severe intracranial atherosclerotic stenosis (ICAS) in improving the 90-day functional outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2024
CompletedFirst Posted
Study publicly available on registry
May 31, 2024
CompletedStudy Start
First participant enrolled
May 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
May 25, 2025
May 1, 2025
4.6 years
May 27, 2024
May 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The modified Rankin Scale (mRS) 0-2
The proportion of the mRS 0-2 at 90 days.
90(±7) days
Secondary Outcomes (7)
The mRS 0-1
90(±7) days
The mRS 0-3
90(±7) days
The shift analysis of the mRS distribution
90(±7) days
The change of National Institute of Health Stroke Scale (NIHSS)
7(±1) days or discharge, whichever came first
Any new stroke (ischemic/hemorrhagic) or all-cause mortality
within 30 days
- +2 more secondary outcomes
Other Outcomes (3)
SAFETY OUTCOME: Symptomatic intracranial hemorrhage
24 (±12) hours
SAFETY OUTCOME: Mortality
90(±7) days
SAFETY OUTCOME: Any intracranial hemorrhage
24 (±12) hours
Study Arms (2)
The intervention group
EXPERIMENTALParticipants will receive immediate angioplasty (with or without stenting) for the culprit vessel and the target residual stenosis should be less than 50%. All participants will receive the best medical treatment (BMT).
The control group
NO INTERVENTIONParticipants will receive BMT alone.
Interventions
Eligibility Criteria
You may qualify if:
- Aged 18 years or older.
- Diagnosed with AIS and baseline NIHSS ≥6.
- Pre-stroke mRS ≤2.
- Time from symptom onset to randomization ≤ 24 hours; the onset time refers to "Last Known Well" (LKW).
- Non-contrast CT ASPECTS score ≥6.
- CTA confirmed severe ICAS (70-99%) of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery, and is presumed to be responsible for the stroke.
- Informed consent signed by the patient or authorized representative.
You may not qualify if:
- Normal diameter of the culprit vessel \<2.0 mm.
- Isolated perforator artery infarction (except for combined cortical hypoperfusion).
- Hemorrhagic stroke within the past 90 days.
- Cerebrovascular conditions such as vasculitis, moya-moya disease, arterial inflammatory stenosis, vasospasm, traumatic dissection, etc..
- Severe calcification at the stenosis site, where expected residual stenosis ≤50% cannot be achieved with procedure.
- Known cardiac thrombus source (e.g., atrial fibrillation, patent foramen ovale, infective endocarditis).
- INR \>1.7 when using warfarin; coagulation dysfunction or uncorrectable bleeding factors.
- Platelet count \<50×10\^9/L.
- Intracranial hemorrhage confirmed by CT or MRI.
- Women who are pregnant or breastfeeding.
- Participation in other intervention clinical trials.
- Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl).
- Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
- Aortic dissection.
- Concomitant intracranial tumor (except for meningioma \<10mm) or arteriovenous malformation.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120, China
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yamei Tang, M.D., Ph.D.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- PRINCIPAL INVESTIGATOR
Yajie Liu, M.D., Ph.D.
Shenzhen Hospital of Southern Medical University
Central Study Contacts
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
May 27, 2024
First Posted
May 31, 2024
Study Start
May 8, 2025
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
May 25, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 6 months after the trial completion.
- Access Criteria
- The IPD will be available from Principal Investigators (Prof. Yamei Tang and Prof. Yajie Liu) upon reasonable request.
The IPD will be available from Principal Investigators (Prof. Yamei Tang and Prof. Yajie Liu) upon reasonable request 6 months after the trial completion.