EPI-EFA: The Study of the Fenestrated Anaconda Device in the Treatment of Abdominal Aortic Aneurysms

Sponsor

Vascutek Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04592185

Collaborator

Federation of Medical Specialties (Other)

106

Enrollment

Locations

71.4

Anticipated Duration (Months)

3.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Diseases Aneurysm	Device: Fenestrated Anaconda™ Device

Detailed 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

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

106 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 21, 2019

Actual Primary Completion Date :

Oct 15, 2020

Anticipated Study Completion Date :

Oct 1, 2025

Outcome Measures

Primary Outcome Measures

Long-term outcome of use of Fenestrated Anaconda [1 year]
Device-related mortality, procedure-related mortality, all-cause mortality

Secondary Outcome Measures

Stent-related adverse events [5 years]
Endoleak, migration, integrity of device
Renal adverse events [5 years]
Renal adverse events
Ischemia [5 years]
Medullary (paraplegia/paraparesis), intestinal

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHR de METZ-THIONVILLE - Hôpital de Mercy	Ars-laquenexy	France	57530
2	Clinique Belharra - BAYONNE	Bayonne	France	64100
3	Clinique Saint-Vincent	Besancon	France	25004
4	CHU de BESANCON	Besancon	France	25030
5	Hôpital Privé de BOIS-BERNARD	Bois-bernard	France	62320
6	Clinique Saint-Augustin	Bordeaux	France	33074
7	CHU de BORDEAUX - GH Pellegrin	Bordeaux	France	33076
8	Polyclinique Bordeaux Nord Aquitaine	Bordeaux	France	33300
9	Clinique Convert de BOURG-EN-BRESSE	Bourg-en-bresse	France	01000
10	CHU de BREST - CH La Cavale Blanche	Brest	France	29200
11	HCL - Hôpital L. Pradel - BRON	Bron	France	69500
12	CHU de CLERMONT-FERRAND - site Gabriel-Montpied	Clermont-ferrand	France	63003
13	CHU de de DIJON BOURGOGNE - Hôpital François Mitterrand	Dijon	France	21079
14	Clinique La Ligne Bleue	Epinal	France	88060
15	Groupe Hospitalier Mutualiste de GRENOBLE	Grenoble	France	38028
16	Centre Hospitalier d'ARCACHON	La Teste-de-buch	France	33164
17	APHM - Hôpital de La Timone	Marseille	France	13385
18	APHM - Hôpital Nord	Marseille	France	13915
19	Polyclinique Inkermann	Niort	France	79027
20	Clinique Geoffroy St-Hilaire	Paris	France	75005
21	Groupe Hospitalier Pitié-Salpêtrière	Paris	France	75013
22	CH de PAU	PAU	France	64046
23	CHU de BORDEAUX - Hôpital Haut-Lévêque	Pessac	France	33604
24	CHU de REIMS - Hôpital Robert Debré	Reims	France	51092
25	Clinique Belledonne	Saint Martin D'heres	France	38400
26	Clinique Mutualiste	Saint-etienne	France	42100
27	CHU de ST-ETIENNE- Hôpital Nord	Saint-priest-en-jarez	France	42270
28	HU de STRASBOURG - Nouvel Hôpital Civil	Strasbourg	France	67091
29	Polyclinique de l'Ormeau	Tarbes	France	65000
30	CHU de NANCY - Hôpitaux de Brabois	Vandoeuvre Les Nancy	France	54511
31	Hôpital Robert Schuman	Vantoux	France	57070
32	Hôpital Privé de VILLENEUVE D'ASCQ	Villeneuve-d'ascq	France	59650
33	Médipôle LYON-VILLEURBANNE	Villeurbanne	France	69110