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

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.

Conditions

• Flow Diverter
• Unruptured Intracranial Aneurysms
• Cerebrovascular Event
• Hemorrhagic Stroke
• Methylprednisolone

Interventions

DRUG

Methylprednisolone (Injectable Form)

This clinical study involves a perioperative pharmacological intervention using Methylprednisolone (Methylprednisolone Sodium Succinate for injection). The intervention is characterized by a weight-based, short-course intravenous regimen initiated preoperatively. The specific and distinguishing protocol is as follows: Drug \& Form: Methylprednisolone Sodium Succinate, injectable formulation. Route \& Method: Intravenous infusion, dissolved in normal saline, administered at a rate of 40-60 drops per minute. Dosing: 2 mg per kilogram of body weight per dose, with a maximum single dose not exceeding 160 mg. Timing \& Duration: The regimen begins preoperatively on the day of surgery (Day 1). It is administered once daily (qd) for a total of 3 consecutive days. This protocol defines a distinct perioperative corticosteroid strategy aimed at modulating the inflammatory response associated with flow-diverting device implantation. It is an add-on therapy to the standard surgical and antiplat

DRUG

Placebo Injection

The placebo intervention is characterized by a volume-matched, short-course intravenous regimen designed to be indistinguishable from the active drug in all aspects of administration except for the active pharmaceutical ingredient. The specific and distinguishing protocol is as follows: Drug \& Form: Matched Placebo (0.9% Sodium Chloride Injection), provided in an identical injectable formulation. Route \& Method: Intravenous infusion, administered at an identical rate of 40-60 drops per minute. Dosing: The infusion contains no active drug. The volume of each infusion is matched to the volume of the Methylprednisolone solution prepared for a participant of equivalent weight in the experimental group. Timing \& Duration: The regimen begins preoperatively on the day of surgery (Day 1). It is administered once daily (qd) for a total of 3 consecutive days, precisely mirroring the active treatment schedule.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Beijing Tiantan Hospital

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• The Affiliated Hospital Of Southwest Medical University

  collaborator OTHER

• Guangdong 999 Brain Hospital

  collaborator OTHER

• Eighth Affiliated Hospital, Sun Yat-sen University

  collaborator OTHER

• ZhuHai Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Zunyi Medical College

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• The Third Affiliated Hospital of Southern Medical University

  collaborator OTHER_GOV

• Dongguan People's Hospital

  collaborator OTHER_GOV

• Shantou Central Hospital

  collaborator OTHER

• the Affiliated hospital of Guilin medical university, China

  collaborator UNKNOWN

• Huizhou Third People's Hospital, Guangzhou Medical University

  collaborator OTHER

• Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine

  collaborator UNKNOWN

• Qingyuan People's Hospital

  collaborator OTHER

• Guigang People's Hospital

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• First Affiliated Hospital of Jinan University

  collaborator OTHER

• Shenzhen People's Hospital

  collaborator OTHER

• Meizhou People's Hospital

  collaborator OTHER

• First People's Hospital of Foshan

  collaborator OTHER

• Duan Chuanzhi

  lead OTHER

Principal Investigators

• Chuanzhi Duan · Southern Medical University, China

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-30

Primary Completion

2027-08-31

Completion

2027-09-01

Countries

• China

Study Locations