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

NCT04592185 — Unknown, 106 participants, Vascutek Ltd.
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Post-registration Observational Study on the Custom-made Abdominal Aortic Endograft Fenestrated Anaconda™

RegistryNCT04592185, acronym EPI-EFA
StatusUnknown
Study typeObservational
Enrollment106 (Actual)
SponsorVascutek Ltd. (Industry); collaborators: Federation of Medical Specialties
ConditionsVascular Diseases, Aneurysm
InterventionsFenestrated Anaconda™ Device (Device)
Datesstart 2019-10-21, primary completion 2020-10-15, completion 2025-10-01 (estimated), first posted 2020-10-19, last updated 2022-04-28
Locations33 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for Vascular Diseases All trials for Aneurysm All trials of Fenestrated Anaconda™ Device

-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.

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+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

+Arms and interventions

  • Fenestrated Anaconda™ Device (Device): Treatment of complex abdominal aortic aneurysms

+Outcome measures

Primary outcomes

  • Long-term outcome of use of Fenestrated Anaconda [1 year]: Device-related mortality, procedure-related mortality, all-cause mortality

Secondary outcomes

  • Stent-related adverse events [5 years]: Endoleak, migration, integrity of device
  • Renal adverse events [5 years]: Renal adverse events
  • Ischemia [5 years]: Medullary (paraplegia/paraparesis), intestinal

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (33)

FacilityCityCountryStatus
CHR de METZ-THIONVILLE - Hôpital de MercyArs-LaquenexyFrance
Clinique Belharra - BAYONNEBayonneFrance
Clinique Saint-VincentBesançonFrance
CHU de BESANCONBesançonFrance
Hôpital Privé de BOIS-BERNARDBois-BernardFrance
Clinique Saint-AugustinBordeauxFrance
CHU de BORDEAUX - GH PellegrinBordeauxFrance
Polyclinique Bordeaux Nord AquitaineBordeauxFrance
Clinique Convert de BOURG-EN-BRESSEBourg-en-BresseFrance
CHU de BREST - CH La Cavale BlancheBrestFrance
HCL - Hôpital L. Pradel - BRONBronFrance
CHU de CLERMONT-FERRAND - site Gabriel-MontpiedClermont-FerrandFrance
CHU de de DIJON BOURGOGNE - Hôpital François MitterrandDijonFrance
Clinique La Ligne BleueÉpinalFrance
Groupe Hospitalier Mutualiste de GRENOBLEGrenobleFrance
Centre Hospitalier d'ARCACHONLa Teste-de-BuchFrance
APHM - Hôpital de La TimoneMarseilleFrance
APHM - Hôpital NordMarseilleFrance
Polyclinique InkermannNiortFrance
Clinique Geoffroy St-HilaireParisFrance
Groupe Hospitalier Pitié-SalpêtrièreParisFrance
CH de PAUPauFrance
CHU de BORDEAUX - Hôpital Haut-LévêquePessacFrance
CHU de REIMS - Hôpital Robert DebréReimsFrance
Clinique MutualisteSaint-EtienneFrance
Clinique BelledonneSaint-Martin-d'HèresFrance
CHU de ST-ETIENNE- Hôpital NordSaint-Priest-en-JarezFrance
HU de STRASBOURG - Nouvel Hôpital CivilStrasbourgFrance
Polyclinique de l'OrmeauTarbesFrance
CHU de NANCY - Hôpitaux de BraboisVandœuvre-lès-NancyFrance
Hôpital Robert SchumanVantouxFrance
Hôpital Privé de VILLENEUVE D'ASCQVilleneuve-d'AscqFrance
Médipôle LYON-VILLEURBANNEVilleurbanneFrance

+Investigators

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