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

Intracranial Aneurysm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609867
• Other study ID #: FDV-001
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

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