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NCT05571930

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

Completed Last updated 7 October 2022
What this trial tests

trial testing Secondary TEVAR after initial FET procedure in Thoraco-abdominal Aneurysm in 30 participants. Completed in 1 January 2022.

Timeline
1 January 2015
Primary endpoint
1 January 2020
1 January 2022

Quick facts

Lead sponsorUniversity Paul Sabatier of Toulouse
StatusCompleted
Study typeOBSERVATIONAL
Enrollment30
Start date1 January 2015
Primary completion1 January 2020
Estimated completion1 January 2022

Drugs / interventions tested

Conditions studied

Sponsor

University Paul Sabatier of Toulouse

Who can join

Eligibility, any sex, with Thoraco-abdominal Aneurysm or Aortic Dissection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Trials by the same sponsor.

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