Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and De… (NCT05479305) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies
France30 participantsStarted 2023-11-21
Plain-language summary
The study objectives are to assess safety and effectiveness, measured acutely and at the 30-day visit after implantation of the Valiant Captivia physician fenestrated Stent Graft.
Clinical utility measures throughout the procedure and until discharge will be assessed
Who can participate
Age range
18 Years
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
. Subject is at least 18 years of age.
. Subject understands and has signed an Informed Consent approved by the Sponsor for this study.
. Subject must be considered a candidate for revascularisation of BT, LCCA and LSA.
. Subject must be able to tolerate surgical revascularisation of BT, LCCA and LSA.
. Subject has a TAA/PAU which is:
. Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm
. Subject has no thrombus in the proximal neck
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.
. Subject has a non-diseased aortic diameter between 25 mm and 42 mm and max diameter of the ascending aorta is ≤ 40 mm
Exclusion criteria
. Subject has an aneurysmal, tortuous, or atherosclerotic LSA.
. Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.
. Subject has an aneurysmal, tortuous, or atherosclerotic BT.
. Subject has an ascending aorta diameter \> 40 mm
. Subject has thrombus in the proximal neck
. Subject has an emergent need of treatment of the aortic pathology
. Subject has prohibitive calcification, occlusive disease, or tortuosity of intended sealing sites
. Subject has circumferential calcification in the common femoral or external iliac artery or in the common iliac artery with an intraluminal diameter (ID) less than 9 mm at any point proximal to or at the access vessel site unless a surgical adjunctive procedure is planned.