None listed
Conditions
Interventions
Medical Device : 1. Intervention Group and Intervention Details
1) Name of the Intervention Group
Surpass Elite Treatment Group
2) Description of the Intervention
All enrolled subjects will undergo f
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Male and female adults aged =19 and <75 years at the time of enrollment b) Patients diagnosed with unruptured intracranial aneurysm by neuroimaging who are indicated for treatment with a flow diverter stent, - according to the following Korean national insurance criteria: 1. Unruptured intracranial aneurysm with a maximum diameter =10 mm 2. Unruptured intracranial aneurysm <10 mm in diameter, meeting at least one of the following conditions: ? Blister-type aneurysm of the distal internal carotid artery ? Fusiform aneurysm ? Dissecting aneurysm of the vertebral artery ? Multiple adjacent aneurysms of the intracranial internal carotid artery with a combined diameter of =10 mm c) Cases in which coil embolization is combined with flow diverter stent placement for aneurysms =15 mm in diameter d) Patients capable of attending outpatient follow-up visits and undergoing neuroimaging after the procedure
Exclusion criteria
Exclusion criteria: a) Individuals aged =18 years or =76 years b) Patients with acute infectious, traumatic, or pseudoaneurysms c) Patients with significant neurological deficits at the time of treatment, defined as a modified Rankin Scale (mRS) score of 3 or higher, which would hinder accurate evaluation of complications d) Patients deemed by the investigator to be at high risk of thromboembolic stroke, including those with a history requiring long-term dual antiplatelet therapy, atrial fibrillation requiring anticoagulation, or intracranial/extracranial vascular occlusion or =70% stenosis e) Patients with other concomitant intracranial pathologies such as brain tumors, moyamoya disease, or arteriovenous malformations f) Patients with liver dysfunction (AST or ALT >100 IU/L), renal impairment (eGFR <30 ml/min/1.73 m²), or uncorrected coagulopathy g) Patients with known hypersensitivity to materials used in the flow diverter device, including platinum, tungsten, nickel, or stainless steel h) Patients with a history of severe adverse reactions to contrast media i) Patients unable to comply with regular follow-up visits j) Patients who are unable to use antiplatelet agents, including those with poor medication adherence k) Female patients who test positive for pregnancy during initial screening, are planning to become pregnant within 12 months after coiling, or are breastfeeding l) Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete aneurysm occlusion as determined by follow-up imaging (TFCA, MRA, or CTA) at 12 months after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure success and treatment-related complications: Thromboembolic and hemorrhagic complications occurring during the procedure or within 30 days post-treatment;Delayed cerebral hemorrhage or infarction: Thromboembolic and hemorrhagic complications occurring between 1 month and 12 months after treatment;Worsening of the modified Rankin Scale (mRS) score: Any deterioration in mRS score from post-procedure to the end of the 12-month follow-up;Changes in the flow diverter stent observed on 12-month imaging: Including degree of in-stent stenosis and morphological changes such as stent migration, shortening, or "fish-mouth" appearance | — |
Countries
Korea, Republic of
Contacts
Public ContactJune Ho Choi
Asan Medical Center
Outcome results
None listed