Vascular DiseasesEPI-EFANCT04592185
The Study of the Fenestrated Anaconda Device in the Treatment of Abdominal Aortic Aneurysms
An observational study of Vascular Diseases and Aneurysm, run by Vascutek Ltd. at 33 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases, Aneurysm
- What is being tested?
- Fenestrated Anaconda™ Device
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 33 sitesFrance
- Study dates
- 21 Oct 2019to Oct 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
France33 sites
CHR de METZ-THIONVILLE - Hôpital de Mercy
Ars-Laquenexy, 57530
Clinique Belharra - BAYONNE
Bayonne, 64100
Clinique Saint-Vincent
Besançon, 25004
CHU de BESANCON
Besançon, 25030
Hôpital Privé de BOIS-BERNARD
Bois-Bernard, 62320
Clinique Saint-Augustin
Bordeaux, 33074
CHU de BORDEAUX - GH Pellegrin
Bordeaux, 33076
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
Clinique Convert de BOURG-EN-BRESSE
Bourg-en-Bresse, 01000
CHU de BREST - CH La Cavale Blanche
Brest, 29200
HCL - Hôpital L. Pradel - BRON
Bron, 69500
CHU de CLERMONT-FERRAND - site Gabriel-Montpied
Clermont-Ferrand, 63003
CHU de de DIJON BOURGOGNE - Hôpital François Mitterrand
Dijon, 21079
Clinique La Ligne Bleue
Épinal, 88060
Groupe Hospitalier Mutualiste de GRENOBLE
Grenoble, 38028
Centre Hospitalier d'ARCACHON
La Teste-de-Buch, 33164
APHM - Hôpital de La Timone
Marseille, 13385
APHM - Hôpital Nord
Marseille, 13915
Polyclinique Inkermann
Niort, 79027
Clinique Geoffroy St-Hilaire
Paris, 75005
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
CH de PAU
Pau, 64046
CHU de BORDEAUX - Hôpital Haut-Lévêque
Pessac, 33604
CHU de REIMS - Hôpital Robert Debré
Reims, 51092
Clinique Mutualiste
Saint-Etienne, 42100
Clinique Belledonne
Saint-Martin-d'Hères, 38400
CHU de ST-ETIENNE- Hôpital Nord
Saint-Priest-en-Jarez, 42270
HU de STRASBOURG - Nouvel Hôpital Civil
Strasbourg, 67091
Polyclinique de l'Ormeau
Tarbes, 65000
CHU de NANCY - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54511
Hôpital Robert Schuman
Vantoux, 57070
Hôpital Privé de VILLENEUVE D'ASCQ
Villeneuve-d'Ascq, 59650
Médipôle LYON-VILLEURBANNE
Villeurbanne, 69110
About this study
Official title: 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.
Read the 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
- Being tested
- Fenestrated Anaconda™ Device
- Keywords
- FEVAR, Fenestrated, Endovascular, AAA, Custom device
- Medical subject headings
- Vascular Diseases, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenestrated Anaconda™ DeviceDevice
Treatment of complex abdominal aortic aneurysms
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term outcome of use of Fenestrated Anaconda
Device-related mortality, procedure-related mortality, all-cause mortality
Measured: 1 year
Secondary outcomes (3)
Stent-related adverse events
Endoleak, migration, integrity of device
Measured: 5 years
Renal adverse events
Renal adverse events
Measured: 5 years
Ischemia
Medullary (paraplegia/paraparesis), intestinal
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start21 Oct 2019
- Primary completion15 Oct 2020
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federation of Medical Specialties
- Responsible party
- Sponsor
- Investigators
- Pr. Jean-Noël Albertini, Principal investigator, CHU de ST-ETIENNE- Hôpital Nord, SAINT-PRIEST-EN-JAREZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592185
- Sponsor's protocol ID
- EPI-EFA
- Acronym
- EPI-EFA
- Status last verified
- Apr 2022
- First submitted
- 15 Oct 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-registration Observational Study on the Custom-made Abdominal Aortic Endograft Fenestrated Anaconda™
- ClinicalTrials.gov ID
- NCT04592185
- Acronym / sponsor ID
- EPI-EFA / EPI-EFA
- Conditions
- Vascular Diseases, Aneurysm
- Keywords
- FEVAR, Fenestrated, Endovascular, AAA, Custom device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Federation of Medical Specialties
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenestrated Anaconda™ DeviceTreatment of complex abdominal aortic aneurysms | Device | – |
Primary outcome
Long-term outcome of use of Fenestrated Anaconda
Time frame: 1 year
Device-related mortality, procedure-related mortality, all-cause mortality
3 secondary outcomes
Stent-related adverse events
Time frame: 5 years
Renal adverse events
Time frame: 5 years
Ischemia
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pr. Jean-Noël Albertini principal investigator
CHU de ST-ETIENNE- Hôpital Nord, SAINT-PRIEST-EN-JAREZ
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Diseases and Aneurysm, run by Vascutek Ltd. at 33 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term outcome of use of Fenestrated Anaconda (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.