Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
NCT ID: NCT01793792
Last Updated: 2025-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
153 participants
INTERVENTIONAL
2013-07-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Device: LVIS
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
LVIS™ and LVIS™ Jr
The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
Interventions
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LVIS™ and LVIS™ Jr
The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Microvention-Terumo, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Fiorella, M.D.
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University Medical Center
Locations
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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
Countries
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References
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Fiorella D, Boulos A, Turk AS, Siddiqui AH, Arthur AS, Diaz O, Lopes DK; LVIS investigators. The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial. J Neurointerv Surg. 2019 Apr;11(4):357-361. doi: 10.1136/neurintsurg-2018-014309. Epub 2018 Oct 8.
Related Links
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The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial. Fiorella D, Boulos A, Turk AS, Siddiqui AH, Arthur AS, Diaz O, Lopes DK on behalf of LVIS Investigators
Other Identifiers
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G110188/S004
Identifier Type: OTHER
Identifier Source: secondary_id
CL11002
Identifier Type: -
Identifier Source: org_study_id
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