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Completed

NCT Number: NCT05571930

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

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.

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Key information

Conditions

Thoraco-abdominal Aneurysm Acute Aortic Syndrome Aneurysm Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient with aortic cross replacement by FET and

  • Type 1 and Type 2 Thoracoabdominal aneurysm (TAAA) with a diameter at > 6 cm or
  • an aortic dissection, Type A (TAAD) or Type B (TBAD) with either organ malperfusion due to compression of the true channel or aneurysmal evolution of the dissected aorta, or
  • A defect in the expansion of the FET module

Exclusion criteria

  • No aortic cross replacement by FET

Treatment and study plan

Secondary TEVAR after initial FET procedure

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.

Primary outcomes

  1. Absence of endoleak after secondary connexion

    Time frame: yearly thereafter up to 5 years

    Absence of Type 1A endoleak

Secondary outcomes

  1. Feasibility of the secondary connexion

    Time frame: During the surgery

    Absence of failed procedure

  2. Absence of endoleak after secondary connexion

    Time frame: early thereafter up to 5 years

    Absence of Type 3 endoleak

Sponsors and collaborators

Lead sponsor

University Paul Sabatier of Toulouse

Other

Collaborators

  • Bertrand Marcheix, MD, PhD
  • Jean Baptiste Ricco, MD, PhD
  • Jean Porterie, MD
  • Thibaut Boisroux, MD
  • Xavier Chaufour, MD, PhD

Registry information

Official study title

Outcomes of Secondary Endovascular Aortic Repair After Initial Aortic Cross Replacement by a Frozen Elephant Trunk

Important dates

Study start
2015
Primary completion
2020
Study completion
2022
First posted
Oct 7, 2022
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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