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

NCT04592185 | Unknown

• 1 other identifier: EPI-EFA
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 33

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.

Conditions

Vascular Diseases; Aneurysm

Keywords

FEVAR; Fenestrated; Endovascular; AAA; Custom device

Outcome Measures

Primary Outcomes (1)

• Long-term outcome of use of Fenestrated Anaconda

  Device-related mortality, procedure-related mortality, all-cause mortality

  1 year

Secondary Outcomes (3)

• Stent-related adverse events

  5 years

• Renal adverse events

  5 years

• Ischemia

  5 years

Interventions

Fenestrated Anaconda™ Device DEVICE

Treatment of complex abdominal aortic aneurysms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Vascutek Ltd.: lead
• Federation of Medical Specialties: collaborator

Study Sites (33)

CHR de METZ-THIONVILLE - Hôpital de Mercy

Ars-Laquenexy, 57530, France

Location

Clinique Belharra - BAYONNE

Bayonne, 64100, France

Location

Clinique Saint-Vincent

Besançon, 25004, France

Location

CHU de BESANCON

Besançon, 25030, France

Location

Hôpital Privé de BOIS-BERNARD

Bois-Bernard, 62320, France

Location

Clinique Saint-Augustin

Bordeaux, 33074, France

Location

CHU de BORDEAUX - GH Pellegrin

Bordeaux, 33076, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

Location

Clinique Convert de BOURG-EN-BRESSE

Bourg-en-Bresse, 01000, France

Location

CHU de BREST - CH La Cavale Blanche

Brest, 29200, France

Location

HCL - Hôpital L. Pradel - BRON

Bron, 69500, France

Location

CHU de CLERMONT-FERRAND - site Gabriel-Montpied

Clermont-Ferrand, 63003, France

Location

CHU de de DIJON BOURGOGNE - Hôpital François Mitterrand

Dijon, 21079, France

Location

Clinique La Ligne Bleue

Épinal, 88060, France

Location

Groupe Hospitalier Mutualiste de GRENOBLE

Grenoble, 38028, France

Location

Centre Hospitalier d'ARCACHON

La Teste-de-Buch, 33164, France

Location

APHM - Hôpital de La Timone

Marseille, 13385, France

Location

APHM - Hôpital Nord

Marseille, 13915, France

Location

Polyclinique Inkermann

Niort, 79027, France

Location

Clinique Geoffroy St-Hilaire

Paris, 75005, France

Location

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

CH de PAU

Pau, 64046, France

Location

CHU de BORDEAUX - Hôpital Haut-Lévêque

Pessac, 33604, France

Location

CHU de REIMS - Hôpital Robert Debré

Reims, 51092, France

Location

Clinique Mutualiste

Saint-Etienne, 42100, France

Location

Clinique Belledonne

Saint-Martin-d'Hères, 38400, France

Location

CHU de ST-ETIENNE- Hôpital Nord

Saint-Priest-en-Jarez, 42270, France

Location

HU de STRASBOURG - Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Polyclinique de l'Ormeau

Tarbes, 65000, France

Location

CHU de NANCY - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Hôpital Robert Schuman

Vantoux, 57070, France

Location

Hôpital Privé de VILLENEUVE D'ASCQ

Villeneuve-d'Ascq, 59650, France

Location

Médipôle LYON-VILLEURBANNE

Villeurbanne, 69110, France

Location

MeSH Terms

Conditions

Vascular Diseases; Aneurysm

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Pr. Jean-Noël Albertini

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 19, 2020
• Study Start: October 21, 2019
• Primary Completion: October 15, 2020
• Study Completion: October 1, 2025
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (33)