Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)

The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.

Completed

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subject age between 18 and 75 years
Subject with an unruptured or ruptured(>30days since occurence), wide-necked (neck ≥4mm or dome to neck ratio <2)intracranial saccular aneurysm (<20mm maximum diameter in any plane)

Exclusion criteria

Subject with significant extra or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm.
Subject with any condition which in the opinion of the treating physician would place the subject at high risk of embolic stroke
Subject with contraindications to the use of antiplatelet agents
Subject who is unable to complete the required follow-up

Treatment and study plan

LVIS™ and LVIS™ Jr

Device

The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.

Other names: Low Profile Visualized Intraluminal Support device

Primary outcomes

Primary Effectiveness Composite Success "Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment"

Time frame: 12 months
Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Official study title

Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS

Acronym: LVIS

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2016
First posted: Feb 18, 2013
Registry last updated: Jun 22, 2025

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.

Published trials that share one or more normalized conditions with this study.

Completed