Back to resultsLow-profile Visualized Intraluminal Support -HUD
Primary Purpose
Giant Wide Necked Aneurysms
Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Low Profile Visualized Intraluminal Support Device
Sponsored by
About this trial
This is an expanded access trial for Giant Wide Necked Aneurysms
Eligibility Criteria
Inclusion Criteria:
- Wide neck (neck greater than or equal to 4 or a dome to neck ratio less than two),Intracranial, saccular aneurysm arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4.5mm.
Sites / Locations
- New York University School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02695030
Brief Title
Low-profile Visualized Intraluminal Support -HUD
Official Title
MicroVention Low-profile Visualized Intraluminal Support (LVIS*) or LVIS Jr Humanitarian Use Device (LVIS HUD)
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
5. Study Description
Brief Summary
The MicroVention Low-profile Visualized Intraluminal Support (LVIS*) Device is intended for use with bare platinum embolic coils for the treatment of unruptured, wide neck (neck greater than or equal to 4 or a dome to neck ratio less than two), intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4.5mm.
Detailed Description
Wide neck aneurysms are very difficult to treat both surgically and endovascularly with clipping or coiling. The availability of this neurovascular flow diverter as a Humanitarian Use Device has provided an additional approach to aneurysm occlusion using endovascular techniques.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Wide Necked Aneurysms
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Low Profile Visualized Intraluminal Support Device
Other Intervention Name(s)
Intracranial Stent
Intervention Description
LVIS device is intended for use with bare platinum embolic coils for the treatment of unruptured, wide neck, intracranial, saccular aneurysms.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Wide neck (neck greater than or equal to 4 or a dome to neck ratio less than two),Intracranial, saccular aneurysm arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4.5mm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Riina, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Low-profile Visualized Intraluminal Support -HUD
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