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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier:
NCT01793792
First received: February 14, 2013
Last updated: July 7, 2015
Last verified: July 2015
  Purpose

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 Intervention Phase
Intracranial Aneurysms
Device: LVIS™ and LVIS™ Jr
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS

Resource links provided by NLM:


Further study details as provided by Microvention-Terumo, Inc.:

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

Secondary Outcome Measures:
  • Parent artery patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Any major stroke or death within 30 days , or ipsilateral stroke or neurological death within 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 166
Study Start Date: July 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Device: LVIS
LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device
Device: LVIS™ and LVIS™ Jr
Other Name: Low Profile Visualized Intraluminal Support device

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793792

Locations
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
Engelwood, 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.
Investigators
Principal Investigator: David Fiorella, M.D. Stony Brook University Medical Center
  More Information

No publications provided

Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT01793792     History of Changes
Other Study ID Numbers: CL11002, G110188/S004
Study First Received: February 14, 2013
Last Updated: July 7, 2015
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 26, 2015