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

NCT ID: NCT02609867

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-23
• Study Completion Date: 2018-01-22

Brief Summary

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.

Detailed 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.

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Flowise Cerebral Flow Diverter

Flowise Cerebral Flow Diverter (TaeWoong Medical Co., Ltd. Korea)

Group Type: EXPERIMENTAL

Flowise Cerebral Flow Diverter

Intervention Type: DEVICE

Flowise Cerebral Flow Diverter Placement

Interventions

Flowise Cerebral Flow Diverter

Flowise Cerebral Flow Diverter Placement

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Buyng Moon Kim, PhD. MD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Healthcare System, Severance Hospital

Locations

Yonsei University Healthcare System, Severance Hospital

Seoul, Yeonsei-ro Seodaemun-gu, South Korea

Countries

South Korea

Other Identifiers

FDV-001

Identifier Type: -

Identifier Source: org_study_id