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NCT07353749

PHASE4

Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms

Sponsor: Duan Chuanzhi

View on ClinicalTrials.gov

Summary

Study Title: Testing Methylprednisolone to Prevent Strokes After a Stent Procedure for Brain Aneurysms What is the purpose of this study? This study aims to find out if a short course of a steroid medicine called methylprednisolone can help prevent strokes and other brain-related complications in patients who have a "flow diverter" stent placed to treat an unruptured brain aneurysm. The main goal is to see if this treatment reduces the combined number of new strokes (both clot-related and bleeding-related) or all-cause death within the first 30 days after the procedure. Who can participate? Adults aged 18 or older with an unruptured brain aneurysm (size 3-25mm) who are scheduled to receive a flow-diverting stent and can provide informed consent may be eligible. Key reasons someone might not be able to join include: having multiple aneurysms needing quick treatment, aneurysm located in the posterior circulation, being pregnant or breastfeeding, having a history of recent stroke, having active infections or stomach ulcers, having severe kidney disease, having very high/uncontrolled blood pressure or blood sugar, or already being on long-term steroid therapy. What will happen in the study? This is a multicenter, randomized, double-blind study. This means: Participants will be randomly assigned (like flipping a coin) to one of two groups. One group will receive methylprednisolone. The other group will receive a placebo (an inactive substance that looks identical). Neither the participants nor their doctors will know which treatment is being given. All participants will receive the standard care for the stent procedure and aftercare. How long will the study last? The treatment period is short (around the time of the procedure). Participants will be closely monitored in the hospital and will have a follow-up visit around 30 days after the procedure to check their health status. What will be measured? The researchers will mainly track whether participants have any stroke or all-cause death in the first 30 days. They will also check for other complications like bleeding, infections, and changes in daily function and quality of life. Safety will be monitored throughout. How many people will take part? The study plans to enroll approximately 864 participants across multiple hospitals. Study Dates: The study is expected to start enrolling patients in January 2026 and finish in December 2028. Who is organizing the study? This study is sponsored and led by Zhujiang Hospital, Southern Medical University.

Official title: Efficacy and Safety of Methylprednisolone in Preventing Adverse Cerebrovascular Events After Flow-Diverter Stent Implantation in Patients With Unruptured Intracranial Aneurysms: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

864

Start Date

2026-11-30

Completion Date

2028-12-31

Last Updated

2026-10-26

Healthy Volunteers

Conditions

Unruptured Intracranial Aneurysms Cerebrovascular Event Hemorrhagic Stroke Methylprednisolone Flow Diverter

Interventions

DRUG

Methylprednisolone (Injectable Form)

Methylprednisolone sodium succinate for injection will be administered intravenously at a dose of 2 mg/kg once daily, with a maximum daily dose of 160 mg, for 3 consecutive days. The first dose will be initiated preoperatively on the day of flow-diverter implantation (Day 1). The study drug will be dissolved in 100 mL of normal saline and administered by intravenous infusion at approximately 40-60 drops per minute.

DRUG

Placebo Injection

A matched placebo, identical in appearance and packaging to methylprednisolone sodium succinate for injection, will be administered intravenously according to the same schedule and administration procedure as the active treatment: once daily for 3 consecutive days, beginning preoperatively on the day of flow-diverter implantation (Day 1).

\*\*Inclusion Criteria:\*\* 1. Age ≥18 years. 2. Diagnosis of an unruptured intracranial aneurysm confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA). 3. Target intracranial aneurysm size between 3 mm and 25 mm. 4. The participant and/or legally authorized representative is able to understand the purpose of the study, voluntarily agrees to participate, and provides written informed consent. 5. Planned treatment with a flow-diverting device. 6. Willing and able to complete follow-up assessments according to the study protocol. \*\*Exclusion Criteria:\*\* 1. Two or more intracranial aneurysms requiring a second treatment procedure within 1 month. 2. Target aneurysm located in the posterior circulation, including the vertebral artery, basilar artery, posterior cerebral artery, or related branches. 3. Women who are planning pregnancy, pregnant, or breastfeeding. 4. Pre-event modified Rankin Scale (mRS) score ≥2. 5. Systemic infectious disease in the latent or active phase; ulcerative colitis; diverticulitis; cirrhosis; myasthenia gravis; ocular herpes simplex; active gastrointestinal ulcer; severe fungal infection; or other contraindications to glucocorticoid therapy. 6. Ruptured aneurysm, recurrent aneurysm, infectious aneurysm, or dissecting aneurysm; or concomitant arteriovenous malformation, dural arteriovenous fistula, spinal dural arteriovenous fistula, moyamoya disease, or other specified cerebrovascular malformations. 7. Symptomatic cerebrovascular stenosis ≥70%. 8. Stroke, including cerebral infarction or intracerebral hemorrhage, within the previous 30 days. 9. Planned additional surgical or endovascular procedure within 30 days. 10. Severe comorbidity making anesthesia or the planned procedure unsuitable, including major cardiac, pulmonary, hepatic, splenic, or renal disease; atrial fibrillation; brain tumor; severe active infection; disseminated intravascular coagulation; or severe psychiatric disease. 11. Unable to receive antiplatelet or anticoagulant therapy. 12. Known allergy to methylprednisolone sodium succinate. 13. Long-term glucocorticoid treatment for another condition before surgery (≥1 week). 14. Current use of hepatic enzyme-inducing drugs, including barbiturates, rifampin, rifabutin, carbamazepine, phenytoin, primidone, or aminoglutethimide; or hepatic enzyme-inhibiting drugs, including erythromycin or ketoconazole. 15. Chronic hemodialysis or severe renal impairment, defined as estimated glomerular filtration rate \<30 mL/min or serum creatinine \>220 μmol/L (2.5 mg/dL). 16. Systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg that cannot be adequately controlled with oral antihypertensive therapy. 17. Any of the following glucose abnormalities: * Hypoglycemia: blood glucose ≤2.8 mmol/L in participants without diabetes or ≤3.9 mmol/L in participants with diabetes; or * Hyperglycemia: preoperative random blood glucose ≥12 mmol/L or glycated hemoglobin (HbA1c) ≥9%. 18. Vaccination within the previous month or planned vaccination during the relevant study period. 19. Unable or unwilling to complete follow-up assessments according to the study protocol. 20. Advanced disease with an expected life expectancy \<6 months. 21. Current participation in another clinical trial.

Locations (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China