Study of the Thoraflex™ Hybrid Device for the Treatment of Aneurysm/Dissection of the Descending … (NCT03735472) | Clinical Trial Compass
CompletedNot Applicable
Study of the Thoraflex™ Hybrid Device for the Treatment of Aneurysm/Dissection of the Descending Thoracic Aorta
France351 participantsStarted 2016-04
Plain-language summary
The purpose of this national observational study is to evaluate the Thoraflex™ Hybrid vascular prosthesis in the replacement of the aortic arch and the treatment of aneurysm/dissection of the descending thoracic aorta in relation to morbidity-mortality, visceral malperfusions, neurological and renal complications, endoleak and evolution of the aortic thoracic stent over time.
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 presenting an aneurysm/dissection of the thoracic aorta of the aortic arch and/or the descending thoracic aorta, and necessitating a procedure of the "Elephant Trunk" type, with the Thoraflex™ Hybrid hybrid vascular prosthesis.
Exclusion Criteria:
* Patient having refused to sign the Consent form to the use of his/her data.
* Patient residing abroad, for whom follow-up is not possible.
* Patient with active endocarditis
* Patient who has received a post-infarction septal repair.
* A list of all of the patients who have received the Thoraflex™ Hybrid hybrid vascular prosthesis but not participating in the observational study will be documented, as well as the reasons for non-inclusion
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
1
Patients who did not die, nor suffered paraplegia due to the prosthesis, nor had complications linked to the procedure and surgical conversion