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

Completed

• Conditions: Thoraco-abdominal Aneurysm; Aortic Dissection

• Registration Number: NCT05571930
• Lead Sponsor: University Paul Sabatier of Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2022-01-01
• Study First Submitted: 2022-05-24
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Study First Posted: 2022-10-07
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of endoleak after secondary connexion	yearly thereafter up to 5 years	Absence of Type 1A endoleak

Secondary Outcome Measures

Name	Time	Method
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