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Completed

NCT Number: NCT03553771

Safety and Efficacy of the LVIS and LVIS JR Devices in the Endovascular Treatment of Intracranial Aneurysms

A French, multicenter, prospective, observational, "real life" assessment of the safety and efficacy of LVIS and LVIS JR devices in the treatment of intracranial aneurysms

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Pellgrin, Bordeaux, France

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About this study

This is a multicenter observational study. Treatment and follow-up visits will be done as per standard of care.

The purpose of this study is to collect data on safety of the devices used since the French reimbursement.

130 patients will be enrolled over an 18-month recruitment period. All patients will be followed for at least 12 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device LVIS or LVIS JR, either scheduled or emergency (" Bail-out stenting ")
  • Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data

Exclusion criteria

  • None

Treatment and study plan

LVIS and LVIS JR

Device

Braided coil assist stents used for aneurysm embolization

Other names: Low Profile Visualized Intraluminal Support

Primary outcomes

  1. Mortality Rate

    Time frame: 1 year

  2. Morbidity Rate

    Time frame: 1 year

    Number of adverse events with clinical impact related to the procedure and/or the device

Secondary outcomes

  1. Clinical effectiveness

    Time frame: 1 year

    Number of patients with mRS>2

  2. Anatomical effectiveness

    Time frame: 1 year

    Number of patients with complete occlusion of the treated aneurysm

  3. Retreatment rate

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Collaborators

  • Clinact

Registry information

Official study title

A French, Multicenter, Prospective, Observational, "Real Life" Assessment of the Safety and Efficacy of the Low Profile Visualized Intraluminal Support (LVIS and LVIS JR) Devices in the Treatment of Intracranial Aneurysms

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2018
Registry last updated
Jan 24, 2024

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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