Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis (MAGIC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute Ischemic
• Intervention / Treatment: Procedure: Immediate angioplasty

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.

• Study Type: Interventional
• Enrollment (Estimated): 412
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiongjun He, M.D., Ph.D.; Email: drxjhe@163.com
• Study Contact Backup: Name: Xinguang Yang, M.D.; Phone Number: 86-20-81332619; Email: yangxinguang0926@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Contact: Yang Xinguang, M.D.; Phone Number: 86-20-81332619
      • Principal Investigator: Yamei Tang, M.D., Ph.D.
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Hospital of Southern Medical University
      • Contact: Xiongjun He, M.D., Ph.D.; Email: drxjhe@163.com
      • Principal Investigator: Yajie Liu, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The intervention group; Participants 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).	Procedure: Immediate angioplasty; See arm/group descriptions.
No Intervention: The control group; Participants will receive BMT alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The modified Rankin Scale (mRS) 0-2	The proportion of the mRS 0-2 at 90 days.	90(±7) days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mRS 0-1	The proportion of the mRS of 0-1 at 90 days.	90(±7) days
The mRS 0-3	The proportion of the mRS of 0-3 at 90 days.	90(±7) days
The shift analysis of the mRS distribution	The distribution of the mRS at 90 days.	90(±7) days
The change of National Institute of Health Stroke Scale (NIHSS)	The change of NIHSS from baseline to 7 days or discharge (whichever comes first).	7(±1) days or discharge, whichever came first
The quality of life	The value of quality of life (EQ-5D-5L) at 90 days.	90(±7) days
Any new stroke (ischemic/hemorrhagic) or all-cause mortality	Any new stroke (ischemic/hemorrhagic) or all-cause mortality within 30 days	within 30 days
Any recurrent stroke in the territory of the target artery	Any recurrent stroke in the territory of the target artery within 90 days	within 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAFETY OUTCOME: Symptomatic intracranial hemorrhage	Symptomatic intracranial hemorrhage within 36 hours (according to Heidelberg criteria).	24 (±12) hours
SAFETY OUTCOME: Mortality	Mortality at 90 days.	90(±7) days
SAFETY OUTCOME: Any intracranial hemorrhage	Any intracranial hemorrhage within 36 hours (according to Heidelberg criteria).	24 (±12) hours

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborators: Shenzhen Hospital of Southern Medical University
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Ischemic Stroke; Stroke; Ischemia
• Other Study ID Numbers: SYSKY-2024-337-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will be available from Principal Investigators (Prof. Yamei Tang and Prof. Yajie Liu) upon reasonable request 6 months after the trial completion.
• IPD Sharing Time Frame: 6 months after the trial completion.
• IPD Sharing Access Criteria: The IPD will be available from Principal Investigators (Prof. Yamei Tang and Prof. Yajie Liu) upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No