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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Besançon
      • 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 - Hopital Nord
      • Marseille, France, 13385
        • APHM - Hôpital 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 - Hôpitaux de Brabois
      • Vantoux, France, 57070
        • Hopital Robert Schuman
      • Villeneuve-d'ascq, France, 59650
        • Hopital Prive de Villeneuve d'Ascq
      • Villeurbanne, France, 69110
        • Medipole 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vascutek Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Federation of Medical Specialties

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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