A Prospective, Multicenter, Single arm, Open, Pivotal study to evaluate the safety and effectiveness of the 'FloWise Cerebral Flow Diverter' for the treatment of unruptured wide neck Aneurysm

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005194

Enrollment

Registered

2020-07-02

Start date

2020-07-01

Completion date

Unknown

Last updated

2024-04-02

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 : 'FloWise Cerebral Flow Diverter’ is placed in the parent artery of target intracranial aneurysm.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Functional neurological state =2 mRS(modified Rankin Scale). Unruptured wide-neck aneurysm in the internal carotid artery has -a neck =4mm, or -dome/neck ratio <2 Parent artery of aneurysm with diameter =3.25mm and =5.00mm. Patient willing to provide written informed consent and comply with follow-up requirements.

Exclusion criteria

Exclusion criteria: Female of childbearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding. Intracranial hemorrhage within 30 days. Untreated ruptured intracranial aneurysm =1 intracranial aneurysm except the target one requires treatment within 12 months. Immunosuppressive disease. Active infectious disease. Platelet count < 1,000,000 cells/mm3.

Design outcomes

Primary

Measure	Time frame
Target aneurysm occlusion	—

Secondary

Measure	Time frame
Procedure success rate;Success rate of volume reduction of 50% or more in the target intracranial aneurysm	—

Countries

Korea, Republic of

Contacts

Public ContactByung Moon Kim

Yonsei University Health System, Severance Hospital

bmoon21@hanmail.net+82-2-2228-2399

Outcome results