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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Microvention-Terumo, Inc.
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier:
NCT01793792
First received: February 14, 2013
Last updated: May 27, 2014
Last verified: May 2014
  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: 151
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (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

Contacts
Contact: Mary Schmitz, MS 714 247-8025 mary.schmitz@microvention.com
Contact: Vinny Podichetty, MD 714 247-8043 vinny.podichetty@microvention.com

Locations
United States, Arizona
St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Cheryl Kelly, RN    602-406-6651    cheryl.kelly@dignityhealth.org   
Principal Investigator: Cameron McDougall, MD         
United States, California
Dignity Health/Mercy San Juan Medical Center Recruiting
Carmichael, California, United States, 95608
Contact: Isabel Reyes, MSN       isabel.reyes3@dignityhealth.org   
Principal Investigator: George Luh, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Christy Anton    312-942-1489    Christy_Anton@rush.edu   
Principal Investigator: Demetrius Lopes, MD         
Advocate Health and Hospital Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Diane Lelo, RN    708-684-4698    diane.lelo@advocatehealth.com   
Principal Investigator: Thomas Grobelny, MD         
United States, Indiana
Indiana University/Methodist Research Institute Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Caroline Lynn, RN    317-962-2037    clynn@iuhealth.org   
Principal Investigator: Andrew DeNardo, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Gabrielle Gill, MA    410-706-3344    ggill@umm.edu   
Principal Investigator: Dheeraj Gandhi, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Michelle Bettle    617-636-7606    MBettle@tuftsmedicalcenter.org   
Principal Investigator: Adel Malek, MD, PhD         
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Mary Howk    774-441-8442    mary.howk@umassmed.edu   
Principal Investigator: Ajit S Puri, MD         
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Jennifer Fease    612-863-5053    jennifer.fease@allina.com   
Principal Investigator: Ben Crandall, DO         
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Kathleen Miller, BSN    612-624-8280    mill4109@umn.edu   
Principal Investigator: Ramu Tummala, MD         
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Linda Graca, LPN       gracal@mail.amc.edu   
Principal Investigator: Alan Boulos, MD         
University at Buffalo Neurosurgery Recruiting
Buffalo, New York, United States, 14203
Contact: Jennifer Gay    716-888-4811    jgay@ubns.com   
Principal Investigator: Adnan Siddiqui, PhD/MD         
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Kimberly Lombardo, RN       klombardo2@nshs.edu   
Principal Investigator: Avi Setton, MD         
St. Luke's Roosevelt Hospital Center Recruiting
New York, New York, United States, 10019
Contact: Ahmed Otokiti, MB BS    212-636-3217    aotokiti@CHPNET.ORG   
Principal Investigator: Srinivasan Paramasivam, MD         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Marlene Baumeister, RN       marlene.baumeister@stonybrookmedicine.edu   
Principal Investigator: Henry Woo, MD         
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Mark Villwock, MS       villwocm@upstate.edu   
Principal Investigator: Eric Deshaies, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jennifer Turczyk    216-445-4488    turczyj@ccf.org   
Principal Investigator: Peter A Rasmussen, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15219
Contact: Lisa Baxendell, RN    412-605-3959    baxelx@upmc.edu   
Principal Investigator: Brian Jankowitz, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Adrian Parker    843-792-3164    parkerad@musc.edu   
Contact: Meredith Robinson, MS    843-792-7971    robme@musc.edu   
Principal Investigator: Aquilla Turk, DO         
United States, Tennessee
Methodist University Hospital Recruiting
Memphis, Tennessee, United States, 38120
Contact: Hani Rashed, MD       Hani.Rashed@mlh.org   
Principal Investigator: Adam Arthur, MD         
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Jessica Marlin    615-322-6037    jessica.s.marlin@vanderbilt.edu   
Principal Investigator: J Mocco, MD         
United States, Texas
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Melissa Whipple, RN    713-441-3247    mbwhipple@HoustonMethodist.org   
Principal Investigator: Orlando Diaz, MD         
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: May 27, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 20, 2014