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
• Status: Active, not recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Aneurysm
• Vascular Diseases

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