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Safety and Efficacy of the LVIS and LVIS JR Devices in the Endovascular Treatment of Intracranial Aneurysms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553771
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
Clinact
Information provided by (Responsible Party):
Microvention-Terumo, Inc.

Brief Summary:
A French, multicenter, prospective, observational, "real life" assessment of the safety and efficacy of LVIS and LVIS JR devices in the treatment of intracranial aneurysms

Condition or disease Intervention/treatment
Intracranial Aneurysm Device: LVIS and LVIS JR

Detailed Description:

This is a multicenter observational study. Treatment and follow-up visits will be done as per standard of care.

The purpose of this study is to collect data on safety of the devices used since the French reimbursement.

130 patients will be enrolled over an 18-month recruitment period. All patients will be followed for at least 12 months.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A French, Multicenter, Prospective, Observational, "Real Life" Assessment of the Safety and Efficacy of the Low Profile Visualized Intraluminal Support (LVIS and LVIS JR) Devices in the Treatment of Intracranial Aneurysms
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: LVIS and LVIS JR
    Braided coil assist stents used for aneurysm embolization
    Other Name: Low Profile Visualized Intraluminal Support


Primary Outcome Measures :
  1. Mortality Rate [ Time Frame: 1 year ]
  2. Morbidity Rate [ Time Frame: 1 year ]
    Number of adverse events with clinical impact related to the procedure and/or the procedure


Secondary Outcome Measures :
  1. Clinical effectiveness [ Time Frame: 1 year ]
    Number of patients with mRS>2

  2. Anatomical effectiveness [ Time Frame: 1 year ]
    Number of patients with complete occlusion of the treated aneurysm

  3. Retreatment rate [ Time Frame: 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with ruptured or not ruptured intracranial aneurysms treated with LVIS or LVIS Jr stent
Criteria

Inclusion Criteria:

  • Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device LVIS or LVIS JR, either scheduled or emergency (" Bail-out stenting ")
  • Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553771


Contacts
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Contact: Laurence Bousquet +33139217746 laurence.bousquet@microvention.com
Contact: Patricia Boyer +33139217746 patricia.boyer@microvention.com

Locations
Show Show 21 study locations
Sponsors and Collaborators
Microvention-Terumo, Inc.
Clinact
Investigators
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Principal Investigator: Michel Piotin, MD Fondation Rothschild, Paris, France
Principal Investigator: Charbel Mounayer, Prof. CHU de Limoges, France

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Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT03553771    
Other Study ID Numbers: LEPI
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Microvention-Terumo, Inc.:
aneurysm
endovascular
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases