Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
- Conditions
- Intracranial Aneurysms
- Interventions
- Device: LVIS™ and LVIS™ Jr
- Registration Number
- NCT01793792
- Lead Sponsor
- Microvention-Terumo, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Device: LVIS LVIS™ and LVIS™ Jr 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
- Primary Outcome Measures
Name Time Method 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" 12 months Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Colorado Neurological Institute
🇺🇸Englewood, Colorado, United States
Albany Medical College
🇺🇸Albany, New York, United States
Indiana University/Methodist Research Institute
🇺🇸Indianapolis, Indiana, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Advocate Health and Hospital
🇺🇸Oak Lawn, Illinois, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
St. Luke's Roosevelt Hospital Center
🇺🇸New York, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Dignity Health/Mercy San Juan Medical Center
🇺🇸Carmichael, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
University at Buffalo Neurosurgery
🇺🇸Buffalo, New York, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States