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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006474

Enrollment

160

Registered

2021-08-20

Start date

2021-09-01

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : ? Stent therapy group for Flow diverter - cerebral aneurysm with a maximum diameter of 7 mm or more using a Flow diverter ? control group - a maximum diameter of 7 mm or more using e

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Korea, Republic of

Contacts

Public ContactJoonho Jung

Yonsei University Health System, Severance Hospital

nschung@yuhs.ac+82-2-2228-2850

Outcome results