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Recruiting NCT06437600

Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis

No phase Interventional Stroke, Acute Ischemic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immediate angioplasty.
Who it may be relevant to
Registry conditions: Stroke, Acute Ischemic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis (MAGIC): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial

Overview

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.

Interventions

  • Procedure Immediate angioplasty
    See arm/group descriptions.

Primary outcome measures

  • The modified Rankin Scale (mRS) 0-2 [Time frame: 90(±7) days]
Secondary outcome measures (7)
  • The mRS 0-1 [Time frame: 90(±7) days]
  • The mRS 0-3 [Time frame: 90(±7) days]
  • The shift analysis of the mRS distribution [Time frame: 90(±7) days]
  • The change of National Institute of Health Stroke Scale (NIHSS) [Time frame: 7(±1) days or discharge, whichever came first]
  • Any new stroke (ischemic/hemorrhagic) or all-cause mortality [Time frame: within 30 days]
  • Any recurrent stroke in the territory of the target artery [Time frame: within 90 days]
  • The quality of life [Time frame: 90(±7) days]

Eligibility criteria

Inclusion criteria

  • 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.

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.
  • 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.
  • Severe vascular tortuosity, difficult access for intervention, or inability to complete endovascular treatment.
  • Any active bleeding or recent bleeding in the last 1 month.
  • SBP>185 mmHg or DBP>110 mmHg refractory to treatment.
  • Anticipated life expectancy <3 months (e.g., malignancy, severe cardiopulmonary disease, etc.).
  • Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou
  • Shenzhen Hospital of Southern Medical University — Shenzhen

Identifiers

NCT: NCT06437600 · SYSKY-2024-337-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗