Multi center registry of flow diverter treatment for intracranial aneurysms using FRED, initial experience in Japan

Multi center registry of flow diverter treatment for intracranial aneurysms using FRED, initial experience in Japan - FRED PMS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040681

Enrollment

300

Registered

2020-06-10

Start date

2020-07-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

intracranial aneurysm

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 intracranial aneurysm 2 treated using FRED

Exclusion criteria

Exclusion criteria: reject for registration by patient or family

Design outcomes

Primary

Measure	Time frame
stroke and death within 30 days after treatment	—

Secondary

Measure	Time frame
1. complete occlusion at 1 year after treatment 2. symptomatic stroke within 1 year after treatment 3, neurological death within 1 year after treatment 4. complete occluuion at 3 year after treatment 5. rupture of target aneurysm 6. re-treatment of target aneurysm 7. change in modified Rankin Scale 8. Severe adverse event within 1 year related to device 9. device failure	—

Countries

Japan

Contacts

Public ContactNobuyuki Sakai

Kobe City Medical Center General Hospital Neurosurgery

n.sakai@siren.ocn.ne.jp078-302-4321

Outcome results