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

A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of 'Flowise Cerebral Flow Diverter' for the Treatment of Unruptured Wide-necked Cerebral Aneurysm in the Internal Carotid Artery

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Flowise Cerebral Flow Diverter

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yeonsei-ro Seodaemun-gu
    • Seoul, Yeonsei-ro Seodaemun-gu, Korea, Republic of, 03722
      • Yonsei University Healthcare System, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flowise Cerebral Flow Diverter; Flowise Cerebral Flow Diverter (TaeWoong Medical Co., Ltd. Korea)	Device: Flowise Cerebral Flow Diverter; Flowise Cerebral Flow Diverter Placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Procedural success is defined as the full expansion of the Flowise identified on angiography and the full coverage of the targeted aneurysm neck in the absence of periprocedural stroke or death.	5days
≥50% intracranial aneurysm size reduction success at 6 month	Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA).	6months
Aneurysm occlusion success at 6month	Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ	6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
≥50% Parent artery stenosis or occlusion		6months
Newly developed neurological disorder	Newly developed neurological disorder is defined as neurological problem lasts for at least 1 month post procedure and ≥3 modified Rankin Scale (mRS).	6months
Ipsilateral stroke	Ipsilateral stroke is defined as ≥5 according to the National Institute of Health Stroke Scale (NIHSS).	6months
30-day death	30-day death was defined as death within 30 days post procedure.	6months
Other adverse events		6months

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Buyng Moon Kim, PhD. MD, Yonsei University Healthcare System, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2015
• Primary Completion (Actual): January 22, 2018
• Study Completion (Actual): January 22, 2018

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 18, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: FDV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided