Clinical trial NCT04592185: The Study of the Fenestrated Anaconda Device in the Treatment of Abdominal Aortic Aneurysms
Official title: Post-registration Observational Study on the Custom-made Abdominal Aortic Endograft Fenestrated Anaconda™
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vascular Diseases
Aneurysm
Keywords: FEVAR
Fenestrated
Endovascular
AAA
Custom device
Lead sponsor: Vascutek Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Federation of Medical Specialties
First posted: 2020-10-19
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In order to meet the French Health Authority (HAS) requirements, this study aims to include all patients treated with the Fenestrated Anaconda™ under real conditions of use in France.

These patients must have a preoperative morphological assessment favourable to the placement of a fenestrated endoprosthesis. The affected patients are considered at high risk.

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Long-term outcome of use of Fenestrated Anaconda
timeFrame: 1 year
Secondary outcomes:
measure: Stent-related adverse events
timeFrame: 5 years
measure: Renal adverse events
timeFrame: 5 years
measure: Ischemia
timeFrame: 5 years
Other outcomes:
Locations:
city: Ars-laquenexy
country: France
facility: CHR de METZ-THIONVILLE - Hôpital de Mercy
city: Bayonne
country: France
facility: Clinique Belharra - BAYONNE
city: Besancon
country: France
facility: Clinique Saint-Vincent
city: Besancon
country: France
facility: CHU de BESANCON
city: Bois-bernard
country: France
facility: Hôpital Privé de BOIS-BERNARD
city: Bordeaux
country: France
facility: Clinique Saint-Augustin
city: Bordeaux
country: France
facility: CHU de BORDEAUX - GH Pellegrin
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Bourg-en-bresse
country: France
facility: Clinique Convert de BOURG-EN-BRESSE
city: Brest
country: France
facility: CHU de BREST - CH La Cavale Blanche
city: Bron
country: France
facility: HCL - Hôpital L. Pradel - BRON
city: Clermont-ferrand
country: France
facility: CHU de CLERMONT-FERRAND - site Gabriel-Montpied
city: Dijon
country: France
facility: CHU de de DIJON BOURGOGNE - Hôpital François Mitterrand
city: Epinal
country: France
facility: Clinique La Ligne Bleue
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de GRENOBLE
city: La Teste-de-buch
country: France
facility: Centre Hospitalier d'ARCACHON
city: Marseille
country: France
facility: APHM - Hôpital de La Timone
city: Marseille
country: France
facility: APHM - Hôpital Nord
city: Niort
country: France
facility: Polyclinique Inkermann
city: Paris
country: France
facility: Clinique Geoffroy St-Hilaire
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière
city: PAU
country: France
facility: CH de PAU
city: Pessac
country: France
facility: CHU de BORDEAUX - Hôpital Haut-Lévêque
city: Reims
country: France
facility: CHU de REIMS - Hôpital Robert Debré
city: Saint Martin D'heres
country: France
facility: Clinique Belledonne
city: Saint-etienne
country: France
facility: Clinique Mutualiste
city: Saint-priest-en-jarez
country: France
facility: CHU de ST-ETIENNE- Hôpital Nord
city: Strasbourg
country: France
facility: HU de STRASBOURG - Nouvel Hôpital Civil
city: Tarbes
country: France
facility: Polyclinique de l'Ormeau
city: Vandoeuvre Les Nancy
country: France
facility: CHU de NANCY - Hôpitaux de Brabois
city: Vantoux
country: France
facility: Hôpital Robert Schuman
city: Villeneuve-d'ascq
country: France
facility: Hôpital Privé de VILLENEUVE D'ASCQ
city: Villeurbanne
country: France
facility: Médipôle LYON-VILLEURBANNE
Study officials:
affiliation: CHU de ST-ETIENNE- Hôpital Nord, SAINT-PRIEST-EN-JAREZ
name: Pr. Jean-Noël Albertini
role: PRINCIPAL_INVESTIGATOR
References: