Safety and Efficacy of Flow Diverter Therapy for Unruptured Intracranial Aneurysm Comparing to Traditional Endovascular Strategy: A Multi-center, Randomized, Open-label Trial.

Not Applicable

Active, not recruiting

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0006474
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1) Treatment-related complications: during or after treatment hemorrhagic embolism and hemorrhagic complications that occurred within 30 days.
2) Severe hemorrhagic(Thrombolysis in Myocardial Infarction bleeding criteria)
3) Delayed cerebral hemorrhage: spontaneous intravenous bleeding that occurred within 12 months of treatment
4) Delayed cerebral infarction: cerebral infarction caused by hematosis within 12 months of treatment.
5) Neurological conditions (transfer rate and mortality rate): modified after 1 and 12 months of treatment
Rankin scale score

Exclusion Criteria

1) Adult women and men over 19 to 75 years of age
2) A person who needs treatment due to the initial or recurrence of a cerebral aneurysm with a maximum diameter of 7 mm or more.
3) In the case of recurrence and treatment, a person with Aneurysm Occlusion Grading System Grade 2 or higher.
? Recurrence : Aneurysm Occlusion Grading System
? The results of Grade 2 (70% to 89% aneurysm occlusion) or higher are found when the optimal projection is performed in the catheter cerebrovascularization tracked after coil treatment.
4) Subjects who have heard and finally agreed to the explanation of this study

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)After treatment, 12-month follow-up imaging (TFCA) Complete closure of cerebral aneurysm. 2) Aneurysm Occlusion Grading System: Grade 0 or 1

Secondary Outcome Measures

Name	Time	Method
1) Treatment-related complications: during or after treatment Hemorrhagic embolism and hemorrhagic complications that occurred within 30 days.;2) Severe hemorrhagic (Thrombolysis in Myocardial Infarction bleeding criteria);3) Delayed cerebral hemorrhage: spontaneous intravenous bleeding that occurred within 12 months of treatment;4) Delayed cerebral infarction: cerebral infarction caused by hematosis within 12 months of treatment;5) Neurological conditions (transfer rate and mortality rate): modified after 1 and 12 months of treatment Rankin scale score