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

NCT04592185 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 106

Last updated 2022-04-28

No results posted yet for this study

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.

Conditions

  • Vascular Diseases
  • Aneurysm

Interventions

DEVICE

Fenestrated Anaconda™ Device

Treatment of complex abdominal aortic aneurysms

Sponsors & Collaborators

  • Federation of Medical Specialties

    collaborator OTHER

  • Vascutek Ltd.

    lead INDUSTRY

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2020-10-15
Completion
2025-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04592185 on ClinicalTrials.gov