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

Vascutek

Status: Active, not recruiting

Conditions: Aneurysm; Vascular Diseases

Treatments: Device: Fenestrated Anaconda™ Device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04592185

EPI-EFA

Details and patient eligibility

About

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.

Full 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

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.