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

Completed · Not applicable

Conditions studied: Intracranial Aneurysms

In brief

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.

Key facts

Study ID

NCT01793792

Run by

Microvention-Terumo, Inc.

People needed

153

Starts

2013-07-01

Expected to finish

2016-01-01

Last updated by the study team

2025-06-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Dignity Health/Mercy San Juan Medical Center — Carmichael, California, United States
• Colorado Neurological Institute — Englewood, Colorado, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Advocate Health and Hospital — Oak Lawn, Illinois, United States
• Indiana University/Methodist Research Institute — Indianapolis, Indiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Albany Medical College — Albany, New York, United States
• University at Buffalo Neurosurgery — Buffalo, New York, United States
• North Shore University Hospital — Manhasset, New York, United States
• St. Luke's Roosevelt Hospital Center — New York, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Methodist University Hospital — Memphis, Tennessee, United States
• Vanderbilt University — Nashville, Tennessee, United States
• The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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