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

April 27, 2022 updated by: Vascutek Ltd.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Ars-laquenexy, France, 57530
        • CHR de Metz-Thionville - Hôpital de Mercy
      • Bayonne, France, 64100
        • Clinique Belharra - BAYONNE
      • Besancon, France, 25030
        • CHU de Besancon
      • Besancon, France, 25004
        • Clinique Saint-Vincent
      • Bois-bernard, France, 62320
        • Hôpital Privé de BOIS-BERNARD
      • Bordeaux, France, 33300
        • Polyclinique Bordeaux Nord Aquitaine
      • Bordeaux, France, 33076
        • CHU de Bordeaux - GH Pellegrin
      • Bordeaux, France, 33074
        • Clinique Saint-Augustin
      • Bourg-en-bresse, France, 01000
        • Clinique Convert de BOURG-EN-BRESSE
      • Brest, France, 29200
        • CHU de BREST - CH La Cavale Blanche
      • Bron, France, 69500
        • HCL - Hôpital L. Pradel - BRON
      • Clermont-ferrand, France, 63003
        • CHU de CLERMONT-FERRAND - site Gabriel-Montpied
      • Dijon, France, 21079
        • CHU de de DIJON BOURGOGNE - Hôpital François Mitterrand
      • Epinal, France, 88060
        • Clinique La Ligne Bleue
      • Grenoble, France, 38028
        • Groupe Hospitalier Mutualiste de Grenoble
      • La Teste-de-buch, France, 33164
        • Centre Hospitalier d'Arcachon
      • Marseille, France, 13915
        • APHM - Hôpital Nord
      • Marseille, France, 13385
        • APHM - Hopital de la Timone
      • Niort, France, 79027
        • Polyclinique Inkermann
      • PAU, France, 64046
        • CH de Pau
      • Paris, France, 75013
        • Groupe Hospitalier Pitie-Salpetriere
      • Paris, France, 75005
        • Clinique Geoffroy St-Hilaire
      • Pessac, France, 33604
        • CHU de Bordeaux - Hôpital Haut-Lévêque
      • Reims, France, 51092
        • CHU de Reims - Hôpital Robert Debré
      • Saint Martin D'heres, France, 38400
        • Clinique Belledonne
      • Saint-etienne, France, 42100
        • Clinique Mutualiste
      • Saint-priest-en-jarez, France, 42270
        • CHU de ST-ETIENNE- Hôpital Nord
      • Strasbourg, France, 67091
        • HU de Strasbourg - Nouvel Hopital Civil
      • Tarbes, France, 65000
        • Polyclinique de l'Ormeau
      • Vandoeuvre Les Nancy, France, 54511
        • CHU de Nancy - Hopitaux de Brabois
      • Vantoux, France, 57070
        • Hôpital Robert Schuman
      • Villeneuve-d'ascq, France, 59650
        • Hopital Prive de Villeneuve d'Ascq
      • Villeurbanne, France, 69110
        • Médipôle Lyon-Villeurbanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term outcome of use of Fenestrated Anaconda
Time Frame: 1 year
Device-related mortality, procedure-related mortality, all-cause mortality
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent-related adverse events
Time Frame: 5 years
Endoleak, migration, integrity of device
5 years
Renal adverse events
Time Frame: 5 years
Renal adverse events
5 years
Ischemia
Time Frame: 5 years
Medullary (paraplegia/paraparesis), intestinal
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vascutek Ltd.

Collaborators

Federation of Medical Specialties

Investigators

  • Principal Investigator: Pr. Jean-Noël Albertini, CHU de ST-ETIENNE- Hôpital Nord, SAINT-PRIEST-EN-JAREZ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2019

Primary Completion (Actual)

October 15, 2020

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPI-EFA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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