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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05571930

Enrollment

Registered

2022-10-07

Start date

2015-01-01

Completion date

2022-01-01

Last updated

2022-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Dissection, Thoraco-abdominal Aneurysm

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.

Interventions

PROCEDURESecondary 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026