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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.

Tracking Information
First Submitted Date May 16, 2018
First Posted Date June 12, 2018
Last Update Posted Date October 29, 2018
Actual Study Start Date February 7, 2018
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2018)
  • Mortality Rate [ Time Frame: 1 year ]
  • Morbidity Rate [ Time Frame: 1 year ]
    Number of adverse events with clinical impact related to the procedure and/or the procedure
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03553771 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 30, 2018)
  • Clinical effectiveness [ Time Frame: 1 year ]
    Number of patients with mRS>2
  • Anatomical effectiveness [ Time Frame: 1 year ]
    Number of patients with complete occlusion of the treated aneurysm
  • Retreatment rate [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Efficacy of the LVIS and LVIS JR Devices in the Endovascular Treatment of Intracranial Aneurysms
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
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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients with ruptured or not ruptured intracranial aneurysms treated with LVIS or LVIS Jr stent
Condition Intracranial Aneurysm
Intervention Device: LVIS and LVIS JR
Braided coil assist stents used for aneurysm embolization
Other Name: Low Profile Visualized Intraluminal Support
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 30, 2018)
130
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2022
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Laurence Bousquet +33139217746 laurence.bousquet@microvention.com
Contact: Patricia Boyer +33139217746 patricia.boyer@microvention.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03553771
Other Study ID Numbers LEPI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Microvention-Terumo, Inc.
Study Sponsor Microvention-Terumo, Inc.
Collaborators Clinact
Investigators
Principal Investigator: Michel Piotin, MD Fondation Rothschild, Paris, France
Principal Investigator: Charbel Mounayer, Prof. CHU de Limoges, France
PRS Account Microvention-Terumo, Inc.
Verification Date October 2018