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

NCT02609867 | Completed DMC

• 1 other identifier: FDV-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• ≥50% Parent artery stenosis or occlusion

  6months

• Newly developed neurological disorder

  6months

• Ipsilateral stroke

  6months

• 30-day death

  6months

• Other adverse events

  6months

Study Arms (1)

Flowise Cerebral Flow Diverter

EXPERIMENTAL

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

Device: Flowise Cerebral Flow Diverter

Interventions

Flowise Cerebral Flow Diverter DEVICE

Flowise Cerebral Flow Diverter Placement

Flowise Cerebral Flow Diverter

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Healthcare System, Severance Hospital

Seoul, Yeonsei-ro Seodaemun-gu, 03722, South Korea

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Buyng Moon Kim, PhD. MD

  Yonsei University Healthcare System, Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 20, 2015
• Study Start: October 23, 2015
• Primary Completion: January 22, 2018
• Study Completion: January 22, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

KR (1)