Safety and Efficacy of the LVIS and LVIS JR Devices in the Endovascular Treatment of Intracranial Aneurysms
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|ClinicalTrials.gov Identifier: NCT03553771|
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : October 29, 2018
|Condition or disease||Intervention/treatment|
|Intracranial Aneurysm||Device: LVIS and LVIS JR|
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|
|Estimated Enrollment :||130 participants|
|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|
- Device: LVIS and LVIS JR
Braided coil assist stents used for aneurysm embolizationOther Name: Low Profile Visualized Intraluminal Support
- 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
- 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 ]
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
|Contact: Laurence Bousquetfirstname.lastname@example.org|
|Contact: Patricia Boyeremail@example.com|
|Principal Investigator:||Michel Piotin, MD||Fondation Rothschild, Paris, France|
|Principal Investigator:||Charbel Mounayer, Prof.||CHU de Limoges, France|