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

Sponsor

University Paul Sabatier of Toulouse (Other)

Overall Status

Completed

CT.gov ID

NCT05571930

Collaborator

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

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thoraco-abdominal Aneurysm Aortic Dissection	Procedure: Secondary TEVAR after initial FET procedure

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 1, 2022

Outcome Measures

Primary Outcome Measures

Absence of endoleak after secondary connexion [yearly thereafter up to 5 years]
Absence of Type 1A endoleak

Secondary Outcome Measures

Feasibility of the secondary connexion [During the surgery]
Absence of failed procedure
Absence of endoleak after secondary connexion [early thereafter up to 5 years]
Absence of Type 3 endoleak

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Paul Sabatier of Toulouse
Jean Porterie, MD
Thibaut Boisroux, MD
Bertrand Marcheix, MD, PhD
Jean Baptiste Ricco, MD, PhD
Xavier Chaufour, MD, PhD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aurélien Hostalrich, Hostalrich Aurelien, MD, University Paul Sabatier of Toulouse

ClinicalTrials.gov Identifier:

NCT05571930

Other Study ID Numbers:

TEVAR after THX

First Posted:

Oct 7, 2022

Last Update Posted:

Oct 7, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Aneurysm

Aneurysm, Dissecting

Aortic Aneurysm, Abdominal

Study Results

No Results Posted as of Oct 7, 2022