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NCT04592185 Clinical Trial

The Study of the Fenestrated Anaconda Device in the Treatment of Abdominal Aortic Aneurysms

Vascular Diseases Clinical Trial

— EPI-EFA  

Official title:
Post-registration Observational Study on the Custom-made Abdominal Aortic Endograft Fenestrated Anaconda™

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04592185
Other study ID # EPI-EFA
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 21, 2019
Est. completion date October 2025

Study information
Verified date April 2022
Source Vascutek Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The French Ministry registered the Fenestrated Anaconda ™ on the List of Reimbursable Products and Services (LPPR) by the French Health Insurance on February 2018 for a duration of 5 years, while taking up the conditions for carrying out the act recommended by the CNEDiMTS (Committee in charge of medical device review), namely the carrying out of a post-registration study for the renewal of the authorization. This renewal of registration is conditioned by the set-up of a long-term follow-up study of all patients treated with the Fenestrated Anaconda ™ in France. To do this, this study will be carried out in partnership with the Federation of Medical Specialties (FSM) and the National Professional Council (CNP) of Vascular Surgery in order to have the data necessary for the renewal of the registration of the Fenestrated Anaconda ™ from the registry called Datavasc developed by the CNP and available online on the FSM's electronic platform.

Description:

EPI-EFA study: Post-registration study of the Fenestrated Anaconda™ in the management of a complex abdominal, juxtarenal, pararenal, suprarenal aortic aneurysm, whether or not associated with a distal common iliac artery or thoracoabdominal aneurysm type IV, in high-risk patients requiring treatment, for whom a surgical contraindication has been asked. - Study type : observational, national, multi-centre, prospective, non-comparative study, as open registry - Primary objective : To evaluate the long-term interest of Fenestrated Anaconda™ on all patients treated with in France. The data collected should be: - 1-year mortality rate related to device, procedure, any cause = primary endpoint - Stent-related adverse events (endoleak, migration, integrity of the device), renal events, ischemia (medullary (paraplegia / paraparesis), intestinal) = secondary endpoints - Study timelines : - Duration / follow-up : - 1-year recruitment period from October 2019, with a minimum of 91 patients - Mid-term follow-up : at 1 year - Routine practice : until 5 years - Reports to be submitted to French Health Authority : - Interim report with mid-term follow-up data for renewal dossier - Final report with long-term follow-up data

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 106
Est. completion date October 2025
Est. primary completion date October 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility At the request of the French Health Authority (HAS), no inclusion or exclusion criteria can be set as the study should be carried out on all patients treated with the device in France.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Fenestrated Anaconda™ Device
Treatment of complex abdominal aortic aneurysms

Locations
Country Name City State
France CHR de METZ-THIONVILLE - Hôpital de Mercy Ars-laquenexy
France Clinique Belharra - BAYONNE Bayonne
France CHU de BESANCON Besancon
France Clinique Saint-Vincent Besancon
France Hôpital Privé de BOIS-BERNARD Bois-bernard
France CHU de BORDEAUX - GH Pellegrin Bordeaux
France Clinique Saint-Augustin Bordeaux
France Polyclinique Bordeaux Nord Aquitaine Bordeaux
France Clinique Convert de BOURG-EN-BRESSE Bourg-en-bresse
France CHU de BREST - CH La Cavale Blanche Brest
France HCL - Hôpital L. Pradel - BRON Bron
France CHU de CLERMONT-FERRAND - site Gabriel-Montpied Clermont-ferrand
France CHU de de DIJON BOURGOGNE - Hôpital François Mitterrand Dijon
France Clinique La Ligne Bleue Epinal
France Groupe Hospitalier Mutualiste de GRENOBLE Grenoble
France Centre Hospitalier d'ARCACHON La Teste-de-buch
France APHM - Hôpital de La Timone Marseille
France APHM - Hôpital Nord Marseille
France Polyclinique Inkermann Niort
France Clinique Geoffroy St-Hilaire Paris
France Groupe Hospitalier Pitié-Salpêtrière Paris
France CH de PAU PAU
France CHU de BORDEAUX - Hôpital Haut-Lévêque Pessac
France CHU de REIMS - Hôpital Robert Debré Reims
France Clinique Belledonne Saint Martin D'heres
France Clinique Mutualiste Saint-etienne
France CHU de ST-ETIENNE- Hôpital Nord Saint-priest-en-jarez
France HU de STRASBOURG - Nouvel Hôpital Civil Strasbourg
France Polyclinique de l'Ormeau Tarbes
France CHU de NANCY - Hôpitaux de Brabois Vandoeuvre Les Nancy
France Hôpital Robert Schuman Vantoux
France Hôpital Privé de VILLENEUVE D'ASCQ Villeneuve-d'ascq
France Médipôle LYON-VILLEURBANNE Villeurbanne

Sponsors (2)
Lead Sponsor Collaborator
Vascutek Ltd. Federation of Medical Specialties

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term outcome of use of Fenestrated Anaconda Device-related mortality, procedure-related mortality, all-cause mortality 1 year
Secondary Stent-related adverse events Endoleak, migration, integrity of device 5 years
Secondary Renal adverse events Renal adverse events 5 years
Secondary Ischemia Medullary (paraplegia/paraparesis), intestinal 5 years
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