Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:4/17/2018
Start Date:July 2013
End Date:January 2016

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Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS

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.


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
We found this trial at
21
sites
Memphis, Tennessee 38104
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Manhasset, NY
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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1111 Amsterdam Ave
New York, New York 10025
(212) 523-4000
St Luke's - Roosevelt Hospital Center With 523 beds, Mount Sinai St. Luke's serves as...
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New York, NY
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Albany, NY
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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Buffalo, New York 14209
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Buffalo, NY
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Carmichael, California 95608
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Carmichael, CA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Englewood, Colorado
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Englewood, CO
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Houston, Texas 77030
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Houston, TX
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Indianapolis, IN
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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Minneapolis, MN
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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Oak Lawn, Illinois 60453
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Oak Lawn, IL
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Pittsburgh, PA
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Stony Brook, NY
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