Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis (MAGIC): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke, Acute Ischemic
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Enrollment
- 412
- Locations
- 2
- Primary Endpoint
- The modified Rankin Scale (mRS) 0-2
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Detailed Description
This study is a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the effect of immediate angioplasty (with or without stenting) for AIS with severe ICAS. The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-2. Study intervention: (1) Participants in the intervention group will undergo immediate angioplasty (with or without stenting), and will receive the best medical treatment (BMT) after the procedure. (2) Participants in the control group will receive BMT alone. This study is anticipated to enroll 412 participants.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18 years or older.
- •Diagnosed with AIS and baseline NIHSS ≥
- •Pre-stroke mRS ≤
- •Time from symptom onset to randomization ≤ 24 hours; the onset time refers to "Last Known Well" (LKW).
- •Non-contrast CT ASPECTS score ≥
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The modified Rankin Scale (mRS) 0-2
Time Frame: 90(±7) days
The proportion of the mRS 0-2 at 90 days.
Secondary Outcomes
- 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)
- The quality of life(90(±7) days)
- Any new stroke (ischemic/hemorrhagic) or all-cause mortality(within 30 days)
- Any recurrent stroke in the territory of the target artery(within 90 days)