False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human… (NCT07387250) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_CHL)
15 participantsStarted 2026-04-01
Plain-language summary
To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.
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:
* ≥18 years of age.
* A candidate for false lumen (FL) embolization with a type B dissection, and no prior primary entry tear/TL treatment, OR
* A candidate for FL embolization with a type B or type A dissection, in whom the primary entry tear/TL was treated in a previous procedure, and is now presenting with a FL requiring treatment.
Exclusion Criteria:
* An inability to provide informed consent.
* Enrolled in another clinical study other than a registry.
* Hyperacute or acute aortic dissection (\<15 days from symptom onset).
* Untreated or uncovered primary entry/reentry tear proximal to left subclavian artery (before FL treatment with the investigational product).
* Vascular disease, aortic rupture, and/or anatomy and/or dissection membrane condition that precludes the safe access and positioning of an introducer sheath and delivery (and expansion) of the investigational product into the FL.
* Prior treatment of the FL.
* Planned use of investigational devices to treat the primary entry tear and/or TL.
* Absence of/inability to create a reentry tear/fenestration adequately positioned and large enough to allow introducer sheath access into the FL.
* Planned use of FL embolic devices other than the investigational product.
* Prior abdominal aortic aneurysm (AAA) treatment.
* Planned concomitant major surgery (e.g., gastrointestinal surgery).
* Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos syndr…
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.