Clinical trial NCT01793792: Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
Official title: Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysms
Keywords: intracranial, saccular, aneurysms, stenting, coiling
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-18
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Low Profile Visualized Intraluminal Support device
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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"
timeFrame: 12 months
measure: Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Carmichael
country: United States
facility: Dignity Health/Mercy San Juan Medical Center
state: California
city: Englewood
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Health and Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University/Methodist Research Institute
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Buffalo
country: United States
facility: University at Buffalo Neurosurgery
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
Study officials:
affiliation: Stony Brook University Medical Center
name: David Fiorella, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.