Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
LVIS
Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS
2 other identifiers
interventional
153
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2013
Typical duration for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2013
CompletedFirst Posted
Study publicly available on registry
February 18, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
November 27, 2019
CompletedJune 22, 2025
November 1, 2019
2.3 years
February 14, 2013
September 25, 2019
June 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Device: LVIS
OTHERThe 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
Interventions
The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Dignity Health/Mercy San Juan Medical Center
Carmichael, California, 95608, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Advocate Health and Hospital
Oak Lawn, Illinois, 60453, United States
Indiana University/Methodist Research Institute
Indianapolis, Indiana, 46202, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Albany Medical College
Albany, New York, 12208, United States
University at Buffalo Neurosurgery
Buffalo, New York, 14203, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
St. Luke's Roosevelt Hospital Center
New York, New York, 10019, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Methodist University Hospital
Memphis, Tennessee, 38120, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 30297543DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne Hurley
- Organization
- MicroVention, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
David Fiorella, M.D.
Stony Brook University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2013
First Posted
February 18, 2013
Study Start
July 1, 2013
Primary Completion
November 1, 2015
Study Completion
January 1, 2016
Last Updated
June 22, 2025
Results First Posted
November 27, 2019
Record last verified: 2019-11