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

Criteria the registry did not label

• \*\*Inclusion Criteria:\*\*
• 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.
  • \*\*Exclusion Criteria:\*\*
• 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.
• 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.