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

Not Applicable

Completed

• Conditions: Intracranial Aneurysm
• Interventions: Device: Flowise Cerebral Flow Diverter

• Registration Number: NCT02609867
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2015-10-23
• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Primary Completion: 2018-01-22
• Study Completion: 2018-01-22
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Aneurysm occlusion success at 6month	6months	Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ
Procedural success	5days	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	6months	Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA).

Secondary Outcome Measures

Name	Time	Method
≥50% Parent artery stenosis or occlusion	6months
Newly developed neurological disorder	6months	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	6months	Ipsilateral stroke is defined as ≥5 according to the National Institute of Health Stroke Scale (NIHSS).
30-day death	6months	30-day death was defined as death within 30 days post procedure.
Other adverse events	6months

Trial Locations

Locations (1)

Yonsei University Healthcare System, Severance Hospital; 🇰🇷 Seoul, Yeonsei-ro Seodaemun-gu, Korea, Republic of