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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02609867
Other study ID # FDV-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 23, 2015
Est. completion date January 22, 2018

Study information

Verified date July 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date January 22, 2018
Est. primary completion date January 22, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Flowise Cerebral Flow Diverter
Flowise Cerebral Flow Diverter Placement

Locations

Country Name City State
Korea, Republic of Yonsei University Healthcare System, Severance Hospital Seoul Yeonsei-ro Seodaemun-gu

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary =50% intracranial aneurysm size reduction success at 6 month Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA). 6months
Primary Aneurysm occlusion success at 6month Aneurysm occlusion success is defined as Raymond class ?, ? 6months
Secondary =50% Parent artery stenosis or occlusion 6months
Secondary 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
Secondary Ipsilateral stroke Ipsilateral stroke is defined as =5 according to the National Institute of Health Stroke Scale (NIHSS). 6months
Secondary 30-day death 30-day death was defined as death within 30 days post procedure. 6months
Secondary Other adverse events 6months
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