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Completed

NCT Number: NCT02609867

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

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.

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Key information

Conditions

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

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Healthcare System, Severance Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flowise Cerebral Flow Diverter

Device

Flowise Cerebral Flow Diverter Placement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2015
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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