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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
153
The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
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
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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
...and 11 more locations