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

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ClinicalTrials.gov Identifier: NCT02609867
Recruitment Status : Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Device: Flowise Cerebral Flow Diverter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Flowise Cerebral Flow Diverter
Flowise Cerebral Flow Diverter (TaeWoong Medical Co., Ltd. Korea)
Device: Flowise Cerebral Flow Diverter
Flowise Cerebral Flow Diverter Placement




Primary Outcome Measures :
  1. Procedural success [ Time Frame: 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.

  2. ≥50% intracranial aneurysm size reduction success at 6 month [ Time Frame: 6months ]
    Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA).

  3. Aneurysm occlusion success at 6month [ Time Frame: 6months ]
    Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ


Secondary Outcome Measures :
  1. ≥50% Parent artery stenosis or occlusion [ Time Frame: 6months ]
  2. Newly developed neurological disorder [ Time Frame: 6months ]
    Newly developed neurological disorder is defined as neurological problem lasts for at least 1 month post procedure and ≥3 modified Rankin Scale (mRS).

  3. Ipsilateral stroke [ Time Frame: 6months ]
    Ipsilateral stroke is defined as ≥5 according to the National Institute of Health Stroke Scale (NIHSS).

  4. 30-day death [ Time Frame: 6months ]
    30-day death was defined as death within 30 days post procedure.

  5. Other adverse events [ Time Frame: 6months ]


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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609867


Locations
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Korea, Republic of
Yonsei University Healthcare System, Severance Hospital
Seoul, Yeonsei-ro Seodaemun-gu, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Buyng Moon Kim, PhD. MD Yonsei University Healthcare System, Severance Hospital

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02609867     History of Changes
Other Study ID Numbers: FDV-001
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases