NCT05571930

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
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: University Paul Sabatier of Toulouse · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Thoraco-abdominal Aneurysm
• Aortic Dissection

Interventions

Type	Name	Description
PROCEDURE	Secondary 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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-01-01
• Completion: 2022-01-01
• First posted: 2022-10-07
• Last updated: 2022-10-07