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Outcomes of Secondary Endovascular Aortic Repair After Initial Frozen Elephant Trunk Procedure

NCT05571930 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-10-07

No results posted yet for this study

Summary

Objective Complex aortic pathology has been revolutionized with the use of hybrid prostheses such as the Thoraflex® Hybrid Frozen Elephant Trunk (FET). The aim of this study was to evaluate the midterm results of secondary extension of the FET by thoracic endovascular aortic repair (TEVAR). Few data are present in the literature regarding the outcomes of this secondary treatment.

The investigators perform a prospective study between 2015 and 2022 in a tertiary aortic center on all consecutive patients having undergone TEVAR after FET implantation. The TEVAR endograft covered most of the 10 cm FET module with 2 to 4 mm oversizing. All patients were monitored by computerized angiography (CTA) at 6-month and yearly thereafter.

The aim of this study was the feasibility of theses secondary connexion and the mid term outcomes of the endovascular treatment.

Conditions

  • Thoraco-abdominal Aneurysm
  • Aortic Dissection

Interventions

PROCEDURE

Secondary TEVAR after initial FET procedure

Under general anesthesia, via percutaneous femoral access, the investigators implant a TEVAR in the endovascular part of a FET. This secondary connexion is indicated in case distal thoracic aortic involvement such as aneurysm or dissection.

Sponsors & Collaborators

  • Jean Porterie, MD

    collaborator UNKNOWN

  • Thibaut Boisroux, MD

    collaborator UNKNOWN

  • Bertrand Marcheix, MD, PhD

    collaborator UNKNOWN

  • Jean Baptiste Ricco, MD, PhD

    collaborator UNKNOWN

  • Xavier Chaufour, MD, PhD

    collaborator UNKNOWN

  • University Paul Sabatier of Toulouse

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2020-01-01
Completion
2022-01-01

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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 NCT05571930 on ClinicalTrials.gov