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

October 5, 2022 updated by: Aurélien Hostalrich, University Paul Sabatier of Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with aortic cross replacement by FET who are indicated for a secondary connexion in emergency :

Aortic type A dissection with organ malperfusion Defect in the expansion of the FET module

or in chronical evolution: Type 1 and Type 2 Thoracoabdominal aneurysm (TAAA) with a diameter at > 6 cm Aneurysmal evolution of the false lumen of a dissected aorta.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of endoleak after secondary connexion
Time Frame: yearly thereafter up to 5 years
Absence of Type 1A endoleak
yearly thereafter up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the secondary connexion
Time Frame: During the surgery
Absence of failed procedure
During the surgery
Absence of endoleak after secondary connexion
Time Frame: early thereafter up to 5 years
Absence of Type 3 endoleak
early thereafter up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Paul Sabatier of Toulouse

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEVAR after THX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data are anonymised in our local prospective database shared between all investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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