Clinical trial NCT03553771: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: aneurysm
endovascular
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Clinact
First posted: 2018-06-12
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with ruptured or not ruptured intracranial aneurysms treated with LVIS or LVIS Jr stent

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.

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

Primary outcomes:
measure: Mortality Rate
timeFrame: 1 year
measure: Morbidity Rate
timeFrame: 1 year
Secondary outcomes:
measure: Clinical effectiveness
timeFrame: 1 year
measure: Anatomical effectiveness
timeFrame: 1 year
measure: Retreatment rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Pellgrin
city: Caen
country: France
facility: CHU Caen
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Grenoble
country: France
facility: CHU Michallon
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Limoges
country: France
facility: CHU Limoges
city: Marseille
country: France
facility: Hôpital Clairval
city: Marseille
country: France
facility: Hôpital de la Timone
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Nancy
country: France
facility: Hôpital Central de Nancy
city: Nice
country: France
facility: Hôpital Pasteur 2
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: La Fondation Rothschild
city: Reims
country: France
facility: Hôpital Maison Blanche
city: Saint-Étienne
country: France
facility: Hôpital Nord
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulon
country: France
facility: Hôpital d'instruction des Armées Saint-Anne
city: Toulouse
country: France
facility: Hôpital Purpan
city: Tours
country: France
facility: Hôpital Bretonneau
Study officials:
affiliation: Fondation Rothschild, Paris, France
name: Michel Piotin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Limoges, France
name: Charbel Mounayer, Prof.
role: PRINCIPAL_INVESTIGATOR
References: