Back to resultsA Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)
Primary Purpose
Intracranial Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Flowise Cerebral Flow Diverter
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysm
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.
Sites / Locations
- Yonsei University Healthcare System, Severance Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Flowise Cerebral Flow Diverter
Arm Description
Flowise Cerebral Flow Diverter (TaeWoong Medical Co., Ltd. Korea)
Outcomes
Primary Outcome Measures
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.
≥50% intracranial aneurysm size reduction success at 6 month
Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA).
Aneurysm occlusion success at 6month
Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ
Secondary Outcome Measures
≥50% Parent artery stenosis or occlusion
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).
Ipsilateral stroke
Ipsilateral stroke is defined as ≥5 according to the National Institute of Health Stroke Scale (NIHSS).
30-day death
30-day death was defined as death within 30 days post procedure.
Other adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02609867
Brief Title
A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 23, 2015 (Actual)
Primary Completion Date
January 22, 2018 (Actual)
Study Completion Date
January 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flowise Cerebral Flow Diverter
Arm Type
Experimental
Arm Description
Flowise Cerebral Flow Diverter (TaeWoong Medical Co., Ltd. Korea)
Intervention Type
Device
Intervention Name(s)
Flowise Cerebral Flow Diverter
Intervention Description
Flowise Cerebral Flow Diverter Placement
Primary Outcome Measure Information:
Title
Procedural success
Description
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.
Time Frame
5days
Title
≥50% intracranial aneurysm size reduction success at 6 month
Description
Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA).
Time Frame
6months
Title
Aneurysm occlusion success at 6month
Description
Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ
Time Frame
6months
Secondary Outcome Measure Information:
Title
≥50% Parent artery stenosis or occlusion
Time Frame
6months
Title
Newly developed neurological disorder
Description
Newly developed neurological disorder is defined as neurological problem lasts for at least 1 month post procedure and ≥3 modified Rankin Scale (mRS).
Time Frame
6months
Title
Ipsilateral stroke
Description
Ipsilateral stroke is defined as ≥5 according to the National Institute of Health Stroke Scale (NIHSS).
Time Frame
6months
Title
30-day death
Description
30-day death was defined as death within 30 days post procedure.
Time Frame
6months
Title
Other adverse events
Time Frame
6months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buyng Moon Kim, PhD. MD
Organizational Affiliation
Yonsei University Healthcare System, Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Healthcare System, Severance Hospital
City
Seoul
State/Province
Yeonsei-ro Seodaemun-gu
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)
We'll reach out to this number within 24 hrs