Unruptured Intracranial AneurysmsPhase 4NCT07353749
Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms
A Phase 4 study testing Methylprednisolone (Injectable Form) in people with Unruptured Intracranial Aneurysms and Cerebrovascular Event, run by Duan Chuanzhi at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unruptured Intracranial Aneurysms, Cerebrovascular Event, Hemorrhagic Stroke
- What is being tested?
- Methylprednisolone (Injectable Form)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 864 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2026to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Diagnosis of an unruptured intracranial aneurysm confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
- Target intracranial aneurysm size between 3 mm and 25 mm.
- 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.
- Planned treatment with a flow-diverting device.
- Willing and able to complete follow-up assessments according to the study protocol.
Who cannot join
- Two or more intracranial aneurysms requiring a second treatment procedure within 1 month.
- Target aneurysm located in the posterior circulation, including the vertebral artery, basilar artery, posterior cerebral artery, or related branches.
- Women who are planning pregnancy, pregnant, or breastfeeding.
- Pre-event modified Rankin Scale (mRS) score ≥2.
- 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.
- 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.
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- Symptomatic cerebrovascular stenosis ≥70%.
- Stroke, including cerebral infarction or intracerebral hemorrhage, within the previous 30 days.
- Planned additional surgical or endovascular procedure within 30 days.
- 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.
- Unable to receive antiplatelet or anticoagulant therapy.
- Known allergy to methylprednisolone sodium succinate.
- Long-term glucocorticoid treatment for another condition before surgery (≥1 week).
- 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.
- 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).
- Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg that cannot be adequately controlled with oral antihypertensive therapy.
- 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%.
- Vaccination within the previous month or planned vaccination during the relevant study period.
- Unable or unwilling to complete follow-up assessments according to the study protocol.
- Advanced disease with an expected life expectancy <6 months.
- Current participation in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China 510280
Chuanzhi Duan, 02062782757, doctor_duanzj@163.com
Xin Feng, 13681134001, 13681134001@163.com
About this study
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
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.
Read more
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.
Read the detailed description
Flow-diverting devices (FDs) are widely used for the endovascular treatment of unruptured intracranial aneurysms (UIAs). By redirecting blood flow away from the aneurysm sac, FDs promote intra-aneurysmal thrombosis and subsequent endothelial remodeling, facilitating aneurysm occlusion and parent artery reconstruction. However, ischemic and hemorrhagic cerebrovascular complications remain important concerns following FD implantation, highlighting the need for effective perioperative strategies to improve procedural safety.
The biological processes following FD implantation involve complex interactions among intra-aneurysmal thrombosis, vascular injury, and inflammatory responses. These inflammatory processes may contribute to postprocedural cerebrovascular complications. Methylprednisolone, a glucocorticoid with potent anti-inflammatory effects, may attenuate perioperative inflammatory responses and potentially reduce the risk of adverse cerebrovascular events. Preliminary observational evidence from our research group has suggested an association between perioperative glucocorticoid administration and a lower incidence of cerebrovascular adverse events following FD implantation. However, the nonrandomized nature of these findings limits causal inference, and the efficacy and safety of this treatment strategy require further evaluation in a randomized controlled trial.
This multicenter, randomized, double-blind, placebo-controlled trial is designed to investigate whether short-term perioperative methylprednisolone administration reduces the risk of new stroke or all-cause death within 30 days following FD implantation in patients with UIAs. The study will also evaluate early cerebrovascular complications, neurological and functional outcomes, and treatment-related adverse events to comprehensively assess the potential benefits and risks of methylprednisolone treatment.
The findings of this trial are expected to provide high-quality clinical evidence regarding the efficacy and safety of perioperative methylprednisolone and help inform future perioperative management strategies for patients undergoing FD treatment.
- Conditions
- Unruptured Intracranial Aneurysms, Cerebrovascular Event, Hemorrhagic Stroke, Methylprednisolone, Flow Diverter
- Being tested
- Methylprednisolone (Injectable Form), Placebo Injection
- Keywords
- Flow-diverter devices, Intracranial aneurysm, Methylprednisolone, Cerebrovascular Event
- Medical subject headings
- Hemorrhagic Stroke, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone (Injectable Form)Drug
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.
Placebo InjectionDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone Group | Experimental | Participants assigned to this group will receive methylprednisolone sodium succinate for injection in addition to standard flow-diverter treatment and routine perioperative management. Methylprednisolone sodium succinate 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. Receives: Drug: Methylprednisolone (Injectable Form) |
| Placebo Control Group | Placebo comparator | Participants assigned to this group will receive a matched placebo in addition to the same standard flow-diverter treatment and routine perioperative management. The placebo is matched to methylprednisolone sodium succinate for injection in appearance and packaging and will be administered 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). Receives: Drug: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Any New Stroke or All-Cause Death Within 30 Days
The primary outcome is a composite endpoint of any new ischemic stroke, hemorrhagic stroke, or all-cause death occurring within 30 days after flow-diverter implantation.
Ischemic stroke is defined as a new-onset focal acute neurological deficit lasting at least 24 hours, with cerebral infarction confirmed by computed tomography (CT) or magnetic resonance imaging (MRI).
Hemorrhagic stroke is defined as subarachnoid, intraparenchymal, or intraventricular hemorrhage identified on CT or MRI and associated with new neurological symptoms lasting more than 24 hours, including altered level of consciousness, headache, or focal neurological symptoms, or resulting in seizure. Intracranial hemorrhage will be classified according to the Heidelberg Bleeding Classification.
All-cause death is defined as death from any cause.
Measured: From the day of flow-diverter implantation through 30 days post-procedure; outcome status will be assessed within 24 hours, within 72 hours, at postoperative Day 5 or discharge, and at the 30-day follow-up visit (30 ± 7 days).
Secondary outcomes (15)
Incidence of Any Cerebral Ischemic Event Within 72 Hours, at Day 5/Discharge, and Within 30 Days
Any cerebral ischemic event includes ischemic stroke, transient ischemic attack (TIA), in-stent thrombosis, or emergency revascularization.
The outcome will be reported as the number and proportion of participants experiencing at least one qualifying event.
Measured: Within 72 hours after the procedure; at postoperative Day 5 or discharge; and through 30 days post-procedure.
Incidence of In-Stent Thrombosis Within 30 Days
In-stent thrombosis is defined as thrombus formation at the stent implantation site confirmed by digital subtraction angiography (DSA).
The outcome will be reported as the number and proportion of participants meeting this definition.
Measured: From the flow-diverter implantation procedure through 30 days post-procedure.
Incidence of Emergency Revascularization Within 30 Days
Emergency revascularization is defined as acute occlusion of the target vessel associated with neurological deficits and requiring intravenous thrombolysis, intra-arterial thrombolysis, mechanical thrombectomy, or balloon/stent angioplasty.
The outcome will be reported as the number and proportion of participants meeting this definition.
Measured: From the flow-diverter implantation procedure through 30 days post-procedure.
Incidence of Any Cerebral Hemorrhagic Event Within 72 Hours, at Day 5/Discharge, and Within 30 Days
Any cerebral hemorrhagic event includes intraparenchymal hemorrhage, subarachnoid hemorrhage, or subdural hematoma.
The outcome will be reported as the number and proportion of participants experiencing at least one qualifying event.
Measured: Within 72 hours after the procedure; at postoperative Day 5 or discharge; and through 30 days post-procedure.
All-Cause Mortality Within 30 Days
Death from any cause occurring within 30 days after flow-diverter implantation.
The outcome will be reported as the number and proportion of participants who die from any cause.
Measured: From the flow-diverter implantation procedure through 30 days post-procedure.
Proportion of Participants With Modified Rankin Scale Score 0-2 at 30 Days
The modified Rankin Scale (mRS) assesses global disability on a 7-point scale ranging from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability. The proportion of participants with an mRS score of 0-2 will be reported.
Measured: At the 30-day follow-up visit (30 ± 7 days).
Proportion of Participants With Modified Rankin Scale Score 3-5 at 30 Days
The modified Rankin Scale (mRS) assesses global disability on a 7-point scale ranging from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability. The proportion of participants with an mRS score of 3-5 will be reported.
Measured: At the 30-day follow-up visit (30 ± 7 days).
Incidence of Transient Ischemic Attack Within 72 Hours, at Day 5, and Within 30 Days
Transient ischemic attack (TIA) is defined as transient neurological dysfunction caused by temporary interruption of cerebral blood flow, with complete resolution of symptoms within 24 hours and no corresponding acute cerebral infarction identified on imaging.
The outcome will be reported as the number and proportion of participants experiencing TIA.
Measured: Within 72 hours after the procedure; at postoperative Day 5; and through 30 days post-procedure.
EQ-5D Health-Related Quality-of-Life Score at 30 Days
The EQ-5D assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-5D-derived health utility and self-rated health measures will be assessed and reported.
Measured: At the 30-day follow-up visit (30 ± 7 days).
Incidence of New Moderate or Severe Adverse Events Within 30 Days
New moderate or severe adverse events include any of the following: serious infection requiring hospitalization; new-onset diabetes; clinically significant gastrointestinal bleeding requiring hospitalization; clinically significant fracture or osteonecrosis; cardiovascular events including myocardial infarction, heart failure, or death due to another cardiovascular disease; or other events meeting the protocol-defined criteria for moderate or severe adverse events.
The outcome will be reported as the number and proportion of participants experiencing at least one qualifying event.
Measured: Within 72 hours after the procedure; at postoperative Day 5; and through 30 days post-procedure.
Incidence of Intracranial Hemorrhage Within 72 Hours After Study Treatment
The number and proportion of participants experiencing any intracranial hemorrhage within 72 hours after study treatment will be reported.
Measured: Within 72 hours after study treatment.
Incidence of Systemic Bleeding Complications Within 30 Days
Systemic bleeding complications include gastrointestinal bleeding and generalized subcutaneous bleeding. The number and proportion of participants experiencing a systemic bleeding complication will be reported.
Measured: From the flow-diverter implantation procedure through 30 days post-procedure.
Incidence of Non-Hemorrhagic Serious Adverse Events Within 30 Days
The number and proportion of participants experiencing a serious adverse event other than a hemorrhagic event will be reported according to the protocol-defined criteria for serious adverse events.
Measured: From the flow-diverter implantation procedure through 30 days post-procedure.
Incidence of Gastrointestinal Bleeding Through Postoperative Day 5 or Discharge
The number and proportion of participants experiencing gastrointestinal bleeding through postoperative Day 5 or hospital discharge will be reported. New gastrointestinal bleeding events occurring after discharge will additionally be ascertained at the 30-day follow-up.
Measured: From the day of the procedure through postoperative Day 5 or hospital discharge; post-discharge events will additionally be ascertained through 30 days post-procedure.
Incidence of Pulmonary Infection During Hospitalization
Pulmonary infection is defined as a clinically diagnosed pulmonary infection requiring antibiotic treatment during hospitalization.
The outcome will be reported as the number and proportion of participants meeting this definition.
Measured: During hospitalization, from the day of the procedure through hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start30 Nov 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unruptured Intracranial AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement. Investigators, other blinded investigators, subjects, and sponsors will not have access to any information regarding group assignment or related documents pertaining to the trial drug.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 864 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duan Chuanzhi
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Guangdong Provincial People's Hospital, Beijing Tiantan Hospital, First Affiliated Hospital of Chongqing Medical University, The Affiliated Hospital Of Southwest Medical University, Guangdong 999 Brain Hospital, Eighth Affiliated Hospital, Sun Yat-sen University, ZhuHai Hospital, Henan Provincial People's Hospital, First Affiliated Hospital of Harbin Medical University, Second Affiliated Hospital of Nanchang University, West China Hospital, Zunyi Medical College, Qilu Hospital of Shandong University, Second Affiliated Hospital of Xi'an Jiaotong University, Guangdong Provincial Hospital of Traditional Chinese Medicine, The Third Affiliated Hospital of Southern Medical University, Dongguan People's Hospital, Shantou Central Hospital, Guilin Medical University, China, Huizhou Third People's Hospital, Guangzhou Medical University, Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine, Qingyuan People's Hospital, Guigang People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital of Jinan University, Shenzhen People's Hospital, Meizhou People's Hospital, First People's Hospital of Foshan, Peking Union Medical College Hospital, Deyang People's Hospital, Guizhou Provincial People's Hospital, First Affiliated Hospital of Xinjiang Medical University, Huangshi Central Hospital, Huizhou First Hospital, Maoming People's Hospital, First Affiliated Hospital of Ningbo University, Quanzhou First Hospital, Shanxi Cardiovascular Hospital, Shaoxing People's Hospital, Shenzhen Second People's Hospital, Tianjin Huanhu Hospital, Wuhan Central Hospital, The Affiliated Hospital of Xuzhou Medical University, Yongzhou Central Hospital, The First Affiliated Hospital of Zhengzhou University, The First People's Hospital of Zunyi
- Responsible party
- Sponsor-investigator, Duan Chuanzhi, Zhujiang Hospital
- Investigators
- Chuanzhi Duan, Study director, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353749
- Sponsor's protocol ID
- LC2025D035
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07353749
- Acronym / sponsor ID
- LC2025D035
- Conditions
- Unruptured Intracranial Aneurysms, Cerebrovascular Event, Hemorrhagic Stroke, Methylprednisolone, Flow Diverter
- Keywords
- Flow-diverter devices, Intracranial aneurysm, Methylprednisolone, Cerebrovascular Event
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 864 participants (estimated)
- Lead sponsor
- Duan ChuanzhiUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Guangdong Provincial People's Hospital, Beijing Tiantan Hospital, First Affiliated Hospital of Chongqing Medical University, The Affiliated Hospital Of Southwest Medical University, Guangdong 999 Brain Hospital, Eighth Affiliated Hospital, Sun Yat-sen University, ZhuHai Hospital, Henan Provincial People's Hospital, First Affiliated Hospital of Harbin Medical University, Second Affiliated Hospital of Nanchang University, West China Hospital, Zunyi Medical College, Qilu Hospital of Shandong University, Second Affiliated Hospital of Xi'an Jiaotong University, Guangdong Provincial Hospital of Traditional Chinese Medicine, The Third Affiliated Hospital of Southern Medical University, Dongguan People's Hospital, Shantou Central Hospital, Guilin Medical University, China, Huizhou Third People's Hospital, Guangzhou Medical University, Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine, Qingyuan People's Hospital, Guigang People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital of Jinan University, Shenzhen People's Hospital, Meizhou People's Hospital, First People's Hospital of Foshan, Peking Union Medical College Hospital, Deyang People's Hospital, Guizhou Provincial People's Hospital, First Affiliated Hospital of Xinjiang Medical University, Huangshi Central Hospital, Huizhou First Hospital, Maoming People's Hospital, First Affiliated Hospital of Ningbo University, Quanzhou First Hospital, Shanxi Cardiovascular Hospital, Shaoxing People's Hospital, Shenzhen Second People's Hospital, Tianjin Huanhu Hospital, Wuhan Central Hospital, The Affiliated Hospital of Xuzhou Medical University, Yongzhou Central Hospital, The First Affiliated Hospital of Zhengzhou University, The First People's Hospital of Zunyi
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Flow-diverting devices (FDs) are widely used for the endovascular treatment of unruptured intracranial aneurysms (UIAs). By redirecting blood flow away from the aneurysm sac, FDs promote intra-aneurysmal thrombosis and subsequent endothelial remodeling, facilitating aneurysm occlusion and parent artery reconstruction. However, ischemic and hemorrhagic cerebrovascular complications remain important concerns following FD implantation, highlighting the need for effective perioperative strategies to improve procedural safety.
The biological processes following FD implantation involve complex interactions among intra-aneurysmal thrombosis, vascular injury, and inflammatory responses. These inflammatory processes may contribute to postprocedural cerebrovascular complications. Methylprednisolone, a glucocorticoid with potent anti-inflammatory effects, may attenuate perioperative inflammatory responses and potentially reduce the risk of adverse cerebrovascular events. Preliminary observational evidence from our research group has suggested an association between perioperative glucocorticoid administration and a lower incidence of cerebrovascular adverse events following FD implantation. However, the nonrandomized nature of these findings limits causal inference, and the efficacy and safety of this treatment strategy require further evaluation in a randomized controlled trial.
This multicenter, randomized, double-blind, placebo-controlled trial is designed to investigate whether short-term perioperative methylprednisolone administration reduces the risk of new stroke or all-cause death within 30 days following FD implantation in patients with UIAs. The study will also evaluate early cerebrovascular complications, neurological and functional outcomes, and treatment-related adverse events to comprehensively assess the potential benefits and risks of methylprednisolone treatment.
The findings of this trial are expected to provide high-quality clinical evidence regarding the efficacy and safety of perioperative methylprednisolone and help inform future perioperative management strategies for patients undergoing FD treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement. Investigators, other blinded investigators, subjects, and sponsors will not have access to any information regarding group assignment or related documents pertaining to the trial drug.
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone Group | Experimental | Drug: Methylprednisolone (Injectable Form)Participants assigned to this group will receive methylprednisolone sodium succinate for injection in addition to standard flow-diverter treatment and routine perioperative management. Methylprednisolone sodium succinate 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. |
| Placebo Control Group | Placebo comparator | Drug: Placebo InjectionParticipants assigned to this group will receive a matched placebo in addition to the same standard flow-diverter treatment and routine perioperative management. The placebo is matched to methylprednisolone sodium succinate for injection in appearance and packaging and will be administered 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Diagnosis of an unruptured intracranial aneurysm confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
- Target intracranial aneurysm size between 3 mm and 25 mm.
- 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.
- Planned treatment with a flow-diverting device.
Key exclusion criteria (23 listed)
- Two or more intracranial aneurysms requiring a second treatment procedure within 1 month.
- Target aneurysm located in the posterior circulation, including the vertebral artery, basilar artery, posterior cerebral artery, or related branches.
- Women who are planning pregnancy, pregnant, or breastfeeding.
- Pre-event modified Rankin Scale (mRS) score ≥2.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Methylprednisolone Group |
| Placebo InjectionA 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). | Drug | Placebo Control Group |
Primary outcome
Incidence of Any New Stroke or All-Cause Death Within 30 Days
Time frame: From the day of flow-diverter implantation through 30 days post-procedure; outcome status will be assessed within 24 hours, within 72 hours, at postoperative Day 5 or discharge, and at the 30-day follow-up visit (30 ± 7 days).
The primary outcome is a composite endpoint of any new ischemic stroke, hemorrhagic stroke, or all-cause death occurring within 30 days after flow-diverter implantation. Ischemic stroke is defined as a new-onset focal acute neurological deficit lasting at least 24 hours, with cerebral infarction confirmed by computed tomography (CT) or magnetic resonance imaging (MRI). Hemorrhagic stroke is defined as subarachnoid, intraparenchymal, or intraventricular hemorrhage identified on CT or MRI and associated with new neurological symptoms lasting more than 24 hours, including altered level of consciousness, headache, or focal neurological symptoms, or resulting in seizure. Intracranial hemorrhage will be classified according to the Heidelberg Bleeding Classification. All-cause death is defined as death from any cause.
15 secondary outcomes
Incidence of Any Cerebral Ischemic Event Within 72 Hours, at Day 5/Discharge, and Within 30 Days
Time frame: Within 72 hours after the procedure; at postoperative Day 5 or discharge; and through 30 days post-procedure.
Incidence of In-Stent Thrombosis Within 30 Days
Time frame: From the flow-diverter implantation procedure through 30 days post-procedure.
Incidence of Emergency Revascularization Within 30 Days
Time frame: From the flow-diverter implantation procedure through 30 days post-procedure.
Incidence of Any Cerebral Hemorrhagic Event Within 72 Hours, at Day 5/Discharge, and Within 30 Days
Time frame: Within 72 hours after the procedure; at postoperative Day 5 or discharge; and through 30 days post-procedure.
All-Cause Mortality Within 30 Days
Time frame: From the flow-diverter implantation procedure through 30 days post-procedure.
Proportion of Participants With Modified Rankin Scale Score 0-2 at 30 Days
Time frame: At the 30-day follow-up visit (30 ± 7 days).
Proportion of Participants With Modified Rankin Scale Score 3-5 at 30 Days
Time frame: At the 30-day follow-up visit (30 ± 7 days).
Incidence of Transient Ischemic Attack Within 72 Hours, at Day 5, and Within 30 Days
Time frame: Within 72 hours after the procedure; at postoperative Day 5; and through 30 days post-procedure.
EQ-5D Health-Related Quality-of-Life Score at 30 Days
Time frame: At the 30-day follow-up visit (30 ± 7 days).
Incidence of New Moderate or Severe Adverse Events Within 30 Days
Time frame: Within 72 hours after the procedure; at postoperative Day 5; and through 30 days post-procedure.
Incidence of Intracranial Hemorrhage Within 72 Hours After Study Treatment
Time frame: Within 72 hours after study treatment.
Incidence of Systemic Bleeding Complications Within 30 Days
Time frame: From the flow-diverter implantation procedure through 30 days post-procedure.
Incidence of Non-Hemorrhagic Serious Adverse Events Within 30 Days
Time frame: From the flow-diverter implantation procedure through 30 days post-procedure.
Incidence of Gastrointestinal Bleeding Through Postoperative Day 5 or Discharge
Time frame: From the day of the procedure through postoperative Day 5 or hospital discharge; post-discharge events will additionally be ascertained through 30 days post-procedure.
Incidence of Pulmonary Infection During Hospitalization
Time frame: During hospitalization, from the day of the procedure through hospital discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chuanzhi Duan study director
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone (Injectable Form) in people with Unruptured Intracranial Aneurysms and Cerebrovascular Event, run by Duan Chuanzhi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chuanzhi Duan (02062782757, doctor_duanzj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Any New Stroke or All-Cause Death Within 30 Days (time frame: From the day of flow-diverter implantation through 30 days post-procedure; outcome status will be assessed within 24 hours, within 72 hours, at postoperative Day 5 or discharge, and at the 30-day follow-up visit (30 ± 7 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.