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

Primary Purpose

Intracranial Aneurysms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LVIS™ and LVIS™ Jr
Sponsored by
Microvention-Terumo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysms focused on measuring intracranial, saccular, aneurysms, stenting, coiling

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Hospital and Medical Center
  • Dignity Health/Mercy San Juan Medical Center
  • Colorado Neurological Institute
  • Rush University Medical Center
  • Advocate Health and Hospital
  • Indiana University/Methodist Research Institute
  • University of Maryland
  • Tufts Medical Center
  • Abbott Northwestern Hospital
  • University of Minnesota
  • Albany Medical College
  • University at Buffalo Neurosurgery
  • North Shore University Hospital
  • St. Luke's Roosevelt Hospital Center
  • Stony Brook University Medical Center
  • Cleveland Clinic Foundation
  • University of Pittsburgh Medical Center
  • Medical University of South Carolina
  • Methodist University Hospital
  • Vanderbilt University
  • The Methodist Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Device: LVIS

Arm Description

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

Outcomes

Primary Outcome Measures

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"
Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months

Secondary Outcome Measures

Full Information

First Posted
February 14, 2013
Last Updated
November 21, 2019
Sponsor
Microvention-Terumo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01793792
Brief Title
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
Acronym
LVIS
Official Title
Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microvention-Terumo, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysms
Keywords
intracranial, saccular, aneurysms, stenting, coiling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Low Profile Visualized Intraluminal Support device
Masking
None (Open Label)
Allocation
N/A
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device: LVIS
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
LVIS™ and LVIS™ Jr
Other Intervention Name(s)
Low Profile Visualized Intraluminal Support device
Intervention Description
The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
Primary Outcome Measure Information:
Title
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"
Time Frame
12 months
Title
Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Fiorella, M.D.
Organizational Affiliation
Stony Brook University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Dignity Health/Mercy San Juan Medical Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Advocate Health and Hospital
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Indiana University/Methodist Research Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
University at Buffalo Neurosurgery
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30297543
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.
Results Reference
derived
Links:
URL
https://jnis.bmj.com/content/early/2018/10/15/neurintsurg-2018-014309
Description
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

Learn more about this trial

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

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