Stroke, Acute IschemicMAGICNCT06437600
Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis
A study testing Immediate angioplasty in people with Stroke, Acute Ischemic, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic
- What is being tested?
- Immediate angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 2 sitesChina
- Study dates
- 8 May 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Xiongjun He, M.D., Ph.D. contact
China2 sites, 2 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Yang Xinguang, M.D., 86-20-81332619
Yamei Tang, M.D., Ph.D.
- Recruiting
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong
Xiongjun He, M.D., Ph.D., drxjhe@163.com
Yajie Liu, M.D., Ph.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Acute Ischemic
- Being tested
- Immediate angioplasty
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate angioplastyProcedure or surgery
See arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | 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). Receives: Procedure: Immediate angioplasty |
| The control group | No intervention | Participants will receive BMT alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Rankin Scale (mRS) 0-2
The proportion of the mRS 0-2 at 90 days.
Measured: 90(±7) days
Secondary outcomes (7)
The mRS 0-1
The proportion of the mRS of 0-1 at 90 days.
Measured: 90(±7) days
The mRS 0-3
The proportion of the mRS of 0-3 at 90 days.
Measured: 90(±7) days
The shift analysis of the mRS distribution
The distribution of the mRS at 90 days.
Measured: 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).
Measured: 7(±1) days or discharge, whichever came first
Any new stroke (ischemic/hemorrhagic) or all-cause mortality
Any new stroke (ischemic/hemorrhagic) or all-cause mortality within 30 days
Measured: 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
Measured: within 90 days
The quality of life
The value of quality of life (EQ-5D-5L) at 90 days.
Measured: 90(±7) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start8 May 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Acute IschemicStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University
- Responsible party
- Sponsor
- Investigators
- Yamei Tang, M.D., Ph.D., Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityYajie Liu, M.D., Ph.D., Principal investigator, Shenzhen Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437600
- Sponsor's protocol ID
- SYSKY-2024-337-02
- Acronym
- MAGIC
- Status last verified
- May 2025
- First submitted
- 27 May 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available from Principal Investigators (Prof. Yamei Tang and Prof. Yajie Liu) upon reasonable request 6 months after the trial completion.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis (MAGIC): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06437600
- Acronym / sponsor ID
- MAGIC / SYSKY-2024-337-02
- Conditions
- Stroke, Acute Ischemic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University
- Study start
- 8 May 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Procedure: Immediate angioplastyParticipants 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 intervention | –Participants will receive BMT alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate angioplastySee arm/group descriptions. | Procedure or surgery | The intervention group |
Primary outcome
The modified Rankin Scale (mRS) 0-2
Time frame: 90(±7) days
The proportion of the mRS 0-2 at 90 days.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Yes. The IPD will be available from Principal Investigators (Prof. Yamei Tang and Prof. Yajie Liu) upon reasonable request 6 months after the trial completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiongjun He, M.D., Ph.D. contact
Yamei Tang, M.D., Ph.D. principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Yajie Liu, M.D., Ph.D. principal investigator
Shenzhen Hospital of Southern Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate angioplasty in people with Stroke, Acute Ischemic, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinguang Yang, M.D. (86-20-81332619, yangxinguang0926@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modified Rankin Scale (mRS) 0-2 (time frame: 90(±7) days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.