NCT06437600Recruiting
Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis
Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis (MAGIC): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 25 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 412 (estimated)
- First submitted
- 27 May 2024
- Start date
- 8 May 2025
- Primary completion date
- Dec 2029
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Stroke
- NCT number
- NCT06437600
What you commit to
- Study type: Interventional
- Planned participants: 412
- From 8 May 2025 to the primary completion date, Dec 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant intracranial tumor (except for meningioma \<10mm) or arteriovenous malformation.
Other illness
- Hemorrhagic stroke within the past 90 days.
- Cerebrovascular conditions such as vasculitis, moya-moya disease, arterial inflammatory stenosis, vasospasm, traumatic dissection, etc..
- Known cardiac thrombus source (e.g., atrial fibrillation, patent foramen ovale, infective endocarditis).
- Intracranial hemorrhage confirmed by CT or MRI.
- Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
- Any active bleeding or recent bleeding in the last 1 month.
- 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).
Lab values
- INR \>1.7 when using warfarin; coagulation dysfunction or uncorrectable bleeding factors.
- Platelet count \<50×10\^9/L.
- Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl).
Other
- Normal diameter of the culprit vessel \<2.0 mm.
- Isolated perforator artery infarction (except for combined cortical hypoperfusion).
- Severe calcification at the stenosis site, where expected residual stenosis ≤50% cannot be achieved with procedure.
- Women who are pregnant or breastfeeding.
- Participation in other intervention clinical trials.
- Aortic dissection.
- Severe vascular tortuosity, difficult access for intervention, or inability to complete endovascular treatment.
- SBP\>185 mmHg or DBP\>110 mmHg refractory to treatment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Shenzhen Hospital of Southern Medical University Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.