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

NCT ID: NCT04592185

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-21
• Study Completion Date: 2025-10-31

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

Conditions

Vascular Diseases; Aneurysm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Fenestrated Anaconda™ Device

Treatment of complex abdominal aortic aneurysms

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federation of Medical Specialties

OTHER

Sponsor Role: collaborator

Vascutek Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pr. Jean-Noël Albertini

Role: PRINCIPAL_INVESTIGATOR

CHU de ST-ETIENNE- Hôpital Nord, SAINT-PRIEST-EN-JAREZ

Locations

CHR de METZ-THIONVILLE - Hôpital de Mercy

Ars-Laquenexy, , France

Clinique Belharra - BAYONNE

Bayonne, , France

Clinique Saint-Vincent

Besançon, , France

CHU de BESANCON

Besançon, , France

Hôpital Privé de BOIS-BERNARD

Bois-Bernard, , France

Clinique Saint-Augustin

Bordeaux, , France

CHU de BORDEAUX - GH Pellegrin

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

Épinal, , 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 Mutualiste

Saint-Etienne, , France

Clinique Belledonne

Saint-Martin-d'Hères, , 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

Vandœuvre-lès-Nancy, , France

Hôpital Robert Schuman

Vantoux, , France

Hôpital Privé de VILLENEUVE D'ASCQ

Villeneuve-d'Ascq, , France

Médipôle LYON-VILLEURBANNE

Villeurbanne, , France

Countries

France

Other Identifiers

EPI-EFA

Identifier Type: -

Identifier Source: org_study_id