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

NCT01793792 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2025-06-22

Study results available
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Summary

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.

Conditions

  • Intracranial Aneurysms

Interventions

DEVICE

LVIS™ and LVIS™ Jr

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

Sponsors & Collaborators

  • Microvention-Terumo, Inc.

    lead INDUSTRY

Principal Investigators

  • David Fiorella, M.D. · Stony Brook University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-11-30
Completion
2016-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01793792 on ClinicalTrials.gov