Could a simple steroid prevent strokes after brain aneurysm stenting?
NCT ID NCT07353749
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a short course of the steroid methylprednisolone can reduce the risk of stroke or death within 30 days after a flow-diverter stent is placed to treat an unruptured brain aneurysm. About 864 adults will be randomly assigned to receive either the steroid or a placebo, and neither they nor their doctors will know which they received. The goal is to see if this anti-inflammatory approach can prevent serious brain complications after the procedure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 864 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * (1)Aged ≥ 18 years; (2)Diagnosed with intracranial aneurysm (IA) via CTA, MRA, or DSA; (3)IA size ranging from 3 to 25 mm; (4)The patient and/or their authorized representative can understand the study purpose, voluntarily participate, and sign the informed consent form; (5)Patients scheduled to receive flow diverter treatment; (6)Patients willing to complete follow-up evaluations in accordance with the clinical study protocol. Exclusion Criteria: * (1)Patients with two or more multiple aneurysms who require secondary treatment within one month; (2)Female patients who are planning to become pregnant, are pregnant, or are breastfeeding; (3)Pre-onset modified Rankin Scale (mRS) score ≥ 2; (4)Patients complicated with systemic infectious diseases (latent or active stage), ulcerative colitis, diverticulitis, liver cirrhosis, myasthenia gravis, or ocular herpes simplex; patients with contraindications to glucocorticoids, such as active peptic ulcer and severe fungal infection; (5)Ruptured aneurysms, recurrent aneurysms, infectious aneurysms, dissecting aneurysms; complicated with arteriovenous malformation, dural arteriovenous fistula, spinal dural arteriovenous fistula, moyamoya disease, etc.; (6)Patients with symptomatic cerebrovascular stenosis ≥ 70%; (7)Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 30 days; (8)Patients scheduled to undergo other surgical/interventional procedures within 30 days; (9)Patients with severe comorbidities unsuitable for anesthesia or surgical treatment, such as major diseases of the heart, lungs, liver, spleen, and kidneys, atrial fibrillation, brain tumors, severe active infections, disseminated intravascular coagulation, and severe psychiatric history; (10)Patients who cannot receive antiplatelet aggregation or anticoagulant therapy; (11)Hypersensitivity to methylprednisolone sodium succinate; (12)Patients receiving long-term hormone therapy (≥ 1 week) due to other comorbidities before surgery; (13)Patients taking hepatic enzyme-inducing drugs, such as barbiturates, rifampicin, rifabutin, carbamazepine, phenytoin, primidone, and aminoglutethimide; or patients taking hepatic enzyme-inhibiting drugs, such as erythromycin and ketoconazole; (14)Patients undergoing chronic hemodialysis or with severe renal insufficiency (glomerular filtration rate \< 30 ml/min or serum creatinine \> 220 μmol/L (2.5 mg/dl)); (15)Systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg that is uncontrollable with oral antihypertensive drugs; (16)Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L; (17)Patients who have received a vaccine injection within the past month or have a plan for vaccination; (18)Patients who cannot understand or are unwilling to complete follow-up evaluations in accordance with the clinical study protocol; (19)Patients with advanced diseases with an expected life expectancy of \< 6 months; (20)Patients currently participating in other clinical trials.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China 510280, China
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Other studies related to the condition(s) this trial covers.
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