Trial record 1 of 1 for:    NCT01793792
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Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support) (LVIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01793792
Recruitment Status : Completed
First Posted : February 18, 2013
Last Update Posted : March 23, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysms Device: LVIS™ and LVIS™ Jr Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Low Profile Visualized Intraluminal Support device
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS
Study Start Date : July 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Device: LVIS™ and LVIS™ Jr
The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
Other Name: Low Profile Visualized Intraluminal Support device

Primary Outcome Measures :
  1. Successful aneurysm treatment as defined by complete aneurysm angiographic occlusion without retreatment and no significant stenosis of the treated artery [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Parent artery patency [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Any major stroke or death within 30 days , or ipsilateral stroke or neurological death within 12 months [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01793792

United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
Dignity Health/Mercy San Juan Medical Center
Carmichael, California, United States, 95608
United States, Colorado
Colorado Neurological Institute
Englewood, Colorado, United States, 80113
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Advocate Health and Hospital
Oak Lawn, Illinois, United States, 60453
United States, Indiana
Indiana University/Methodist Research Institute
Indianapolis, Indiana, United States, 46202
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Albany Medical College
Albany, New York, United States, 12208
University at Buffalo Neurosurgery
Buffalo, New York, United States, 14203
North Shore University Hospital
Manhasset, New York, United States, 11030
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10019
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15219
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Methodist University Hospital
Memphis, Tennessee, United States, 38120
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Microvention-Terumo, Inc.
Principal Investigator: David Fiorella, M.D. Stony Brook University Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Microvention-Terumo, Inc. Identifier: NCT01793792     History of Changes
Other Study ID Numbers: CL11002
G110188/S004 ( Other Identifier: FDA )
First Posted: February 18, 2013    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

Keywords provided by Microvention-Terumo, Inc.:
intracranial, saccular, aneurysms, stenting, coiling

Additional relevant MeSH terms:
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases