Completed

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

What is being tested

LVIS™ and LVIS™ Jr

Device

Who is being recruted

Brain Diseases+6

+ Cardiovascular Diseases

+ Central Nervous System Diseases

From 18 to 75 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: July 2013

See protocol details

Summary

Principal SponsorMicrovention-Terumo, Inc.

Last updated: June 22, 2025

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01793792

Principal SponsorMicrovention-Terumo, Inc.

Last updated: June 22, 2025

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

153 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesIntracranial Arterial DiseasesAneurysmIntracranial Aneurysm

Criteria

2 inclusion criteria required to participate

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)

4 exclusion criteria prevent from participating

Subject who is unable to complete the required follow-up

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 with significant extra or intracranial stenosis of the parent artery ( > 50%) proximal to the target aneurysm

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms. Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 21 locations

St. Joseph's Hospital and Medical Center

Phoenix, United StatesOpen St. Joseph's Hospital and Medical Center in Google Maps

Dignity Health/Mercy San Juan Medical Center

Carmichael, United States

Colorado Neurological Institute

Englewood, United States

Rush University Medical Center

Chicago, United States

Completed21 Study Centers