A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)

Yonsei University

Status

Completed

Conditions

Intracranial Aneurysm

Treatments

Device: Flowise Cerebral Flow Diverter

Study type

Interventional

Funder types

Other

Identifiers

NCT02609867

FDV-001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked cerebral aneurysm in the internal carotid artery.

Full description

Flowise is indicated for use in patients with unruptured wide-necked aneurysm in the internal carotid artery. Consecutive subject data should be collected at discharge, 1, 3, and 6 month post Flowise implantation.

Enrollment

10 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Functional neurological state ≤2 mRS
Unruptured wide-neck aneurysm in the internal carotid artery has a size >8mm, a neck ≥4mm, or dome/neck ratio <2
Parent artery with diameter ≥3.25mm and ≤4.5mm
Patient willing to provide written informed consent and comply with follow-up requirements

Exclusion criteria

Intracranial hemorrhage within 30 days
Untreated ruptured intracranial aneurysm
≥1 intracranial aneurysm except the target one requires treatment within 6 months
Immunosuppressive disease
Active infectious disease (e.g. endocarditis, meningitis)
Platelet count < 100 x 103 cells/mm3
Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.