CompletedNot Applicable

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

30 participantsStarted 2015-01-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Absence of endoleak after secondary connexion

Timeframe: yearly thereafter up to 5 years

Trial details

NCT IDNCT05571930

SponsorUniversity Paul Sabatier of Toulouse

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-01-01

View on ClinicalTrials.gov More Thoraco-abdominal Aneurysm trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.