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French Assessment of the Relay Plus and Relay NBS Plus Thoracic Stent-Graft

NCT05030740 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2025-02-19

No results posted yet for this study

Summary

Stent treatment of thoracic aortic pathologies, including aneurysms, pseudo-aneurysms, dissections, intramural hematomas, penetrating ulcers and ruptures of the isthmus, seems to provide a likely benefit compared to surgery in terms of surgical mortality and severe morbidity. However, the data concerning the long-term fate of these stents are insufficient. For this reason, the French National Health Authority (HAS) requests a 5-year follow-up in relation to the renewal of insurance reimbursement for these stent-grafts. Therefore, this long-term observational study has been set up.

Conditions

  • Pathology of the Thoracic Aorta
  • Aneurysm Thoracic
  • Pseudo-aneurysm, Thoracic
  • Dissection of Thoracic Aorta
  • Intramural Haematoma of Thoracic Aorta
  • Penetrating Ulcer of Aorta (Disorder)
  • Rupture of the Isthmus

Sponsors & Collaborators

  • Federation of Medical Specialties

    collaborator OTHER

  • Vascutek Ltd.

    lead INDUSTRY

Principal Investigators

  • Pr. Pascal Desgranges · Henri Mondor Hospital, Creteil, France

Eligibility

Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-18
Primary Completion
2024-01-15
Completion
2024-01-15

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 NCT05030740 on ClinicalTrials.gov