Clinical trial NCT06437600: Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis
Official title: Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis (MAGIC): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute Ischemic
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Shenzhen Hospital of Southern Medical University
First posted: 2024-05-31
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older.
2. Diagnosed with AIS and baseline NIHSS ≥6.
3. Pre-stroke mRS ≤2.
4. Time from symptom onset to randomization ≤ 24 hours; the onset time refers to "Last Known Well" (LKW).
5. Non-contrast CT ASPECTS score ≥6.
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.
7. Informed consent signed by the patient or authorized representative.

Exclusion Criteria:

1. Normal diameter of the culprit vessel \<2.0 mm.
2. Isolated perforator artery infarction (except for combined cortical hypoperfusion).
3. Hemorrhagic stroke within the past 90 days.
4. Cerebrovascular conditions such as vasculitis, moya-moya disease, arterial inflammatory stenosis, vasospasm, traumatic dissection, etc..
5. Severe calcification at the stenosis site, where expected residual stenosis ≤50% cannot be achieved with procedure.
6. Known cardiac thrombus source (e.g., atrial fibrillation, patent foramen ovale, infective endocarditis).
7. INR \>1.7 when using warfarin; coagulation dysfunction or uncorrectable bleeding factors.
8. Platelet count \<50×10\^9/L.
9. Intracranial hemorrhage confirmed by CT or MRI.
10. Women who are pregnant or breastfeeding.
11. Participation in other intervention clinical trials.
12. Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl).
13. Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
14. Aortic dissection.
15. Concomitant intracranial tumor (except for meningioma \<10mm) or arteriovenous malformation.
16. Severe vascular tortuosity, difficult access for intervention, or inability to complete endovascular treatment.
17. Any active bleeding or recent bleeding in the last 1 month.
18. SBP\>185 mmHg or DBP\>110 mmHg refractory to treatment.
19. Anticipated life expectancy \<3 months (e.g., malignancy, severe cardiopulmonary disease, etc.).
20. 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).

Primary outcomes:
measure: The modified Rankin Scale (mRS) 0-2
timeFrame: 90(±7) days
Secondary outcomes:
measure: The mRS 0-1
timeFrame: 90(±7) days
measure: The mRS 0-3
timeFrame: 90(±7) days
measure: The shift analysis of the mRS distribution
timeFrame: 90(±7) days
measure: The change of National Institute of Health Stroke Scale (NIHSS)
timeFrame: 7(±1) days or discharge, whichever came first
measure: Any new stroke (ischemic/hemorrhagic) or all-cause mortality
timeFrame: within 30 days
measure: Any recurrent stroke in the territory of the target artery
timeFrame: within 90 days
measure: The quality of life
timeFrame: 90(±7) days
Other outcomes:
measure: SAFETY OUTCOME: Symptomatic intracranial hemorrhage
timeFrame: 24 (±12) hours
measure: SAFETY OUTCOME: Mortality
timeFrame: 90(±7) days
measure: SAFETY OUTCOME: Any intracranial hemorrhage
timeFrame: 24 (±12) hours
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Yamei Tang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Hospital of Southern Medical University
name: Yajie Liu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: