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

• Status: NOT_YET_RECRUITING
• Trial end date: 2027-09-01

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 brain injury-related deaths 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, 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 brain injury-related 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 August 2027.

Who is organizing the study? This study is sponsored and led by Zhujiang Hospital, Southern Medical University.

• Phase: PHASE4

Details

• Lead Sponsor: Duan Chuanzhi
• Collaborators: Beijing Tiantan Hospital; Dongguan People's Hospital; Eighth Affiliated Hospital, Sun Yat-sen University; First Affiliated Hospital of Chongqing Medical University; First Affiliated Hospital of Harbin Medical University; First Affiliated Hospital of Jinan University; First People's Hospital of Foshan; Guangdong 999 Brain Hospital; Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine; Guangdong Provincial Hospital of Traditional Chinese Medicine; Guangdong Provincial People's Hospital; Guigang People's Hospital; Henan Provincial People's Hospital; Huizhou Third People's Hospital, Guangzhou Medical University; Meizhou People's Hospital; Nanfang Hospital, Southern Medical University; Qilu Hospital of Shandong University; Qingyuan People's Hospital; Second Affiliated Hospital of Nanchang University; Second Affiliated Hospital of Xi'an Jiaotong University; Second Affiliated Hospital, School of Medicine, Zhejiang University; Shantou Central Hospital; Shengjing Hospital; Shenzhen People's Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; the Affiliated hospital of Guilin medical university, China; The Affiliated Hospital Of Southwest Medical University; The First Affiliated Hospital of Guangzhou Medical University; The First Affiliated Hospital of Zhengzhou University; The Third Affiliated Hospital of Southern Medical University; Tongji Hospital; West China Hospital; ZhuHai Hospital; Zunyi Medical College
• Treatments: Methylprednisolone