Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation

Ki vehet részt

• Aged 18 to 75 years old, male or non-pregnant female
• UIA diagnosed by CTA, MRA, or DSA
• Maximal aneurysmal diameter between 3 and 25mm
• Understands the nature of the procedure and provision of written informed consent
• Indications for FD implantation with or without adjunctive coiling
• Is willing to return to the investigational site for follow-up according to our protocol

Ki nem vehet részt

• Prolonged statin therapy (≥30 days) or prior indications for atorvastatin therapy according to the Chinese guidelines for lipid management (2023) 21
• Ruptured aneurysms or target aneurysm received previous operative or endovascular treatment
• Patient currently using drugs that interact with atorvastatin metabolism (including transporter inhibitors, cyclosporine, protease inhibitors, other lipid-lowering medications (such as fibrates, ezetimibe, pcsk9 inhibitor, etc.), antacids, erythromycin, cytochrome P450 enzyme, colchicine, etc.)
• Miss the follow-up due to changes in working/living places, or fortuitous accident (traffic accident, bone fracture, accidental death, ect.). Thus, close follow-up should be conducted to determine their relationship with the usage of FD and experimental drug
• Contraindications to atorvastatin treatment or known allergy to atorvastatin
• Presence of other vascular lesions (coronary artery disease, abdominal aortic aneurysm, intracranial atherosclerotic stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.)
• Other situations that the researcher deems unsuitable for inclusion in the study (inability to receive anti-platelet or anticoagulant medication; allergy or contraindication for the use of FD alloy, history of life-threatening allergy to contrast dye, ect)
• Patients will be excluded if they meet any of the following criteria:
• Pregnancy or lactation
• Patients diagnosed with multiple intracranial aneurysms who require treatment for two or more intracranial aneurysms within a one-year period
• The target aneurysm is non-saccular (dissecting, fusiform, pseudo, infectious, etc.)
• Patient was determined that intravenous general anesthesia or general anesthesia with tracheal intubation could not be tolerated
• Unwilling to be followed up or likely to have poor treatment compliance at initial screening
• Life expectancy less than 3 years
• Severe neurological deficit that renders the patient unable to live independently (modified Rankin score ≥4)
• Enrollment in another trial; Withdrawal criteria; In this trial, participants who have provided written informed consent but are unable to complete the entire study for any reason will be withdrawn. These circumstances include the following:
• The participants voluntarily quit the trial for various reasons
• Occurrence of serious adverse events (SAEs). The study may be terminated by the participants, principal investigators, ethics committee, sponsor, or regulatory authorities based on ethical considerations
• Early termination of the process based on the investigator's judgment in order to prevent development of severe complications
• Significant deviation in implementation, or the subject failed to comply with the scheduled protocol
• Flawed or absence of informed consents