Prospective Evaluation of Physician Modified Endografts for Aortic Disease (NCT07611968) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective Evaluation of Physician Modified Endografts for Aortic Disease
United States20 participantsStarted 2026-07-15
Plain-language summary
The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.
Who can participate
Age range
50 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:
* An aneurysm with a maximum diameter of \>5.5cm in males and \>5.0cm in females in diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
* Aneurysm with a history of growth \> 0.5 cm in 6 months
* Saccular aneurysm deemed at significant risk for rupture
* Symptomatic aneurysm
* Extent of aorta to be treated: type II, III and IV thoracoabdominal.
* Subject is at high-risk of morbidity and mortality with open surgical repair as defined by FEV1 of \<1 liter or uncorrectable coronary disease, frailty, hostile abdomen.
* Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit.
* Non-aneurysmal aortic segment proximal to the aneurysm (neck) with a:
* Minimum neck length of 15mm
* Diameter in the range of 17-32
* Minimum branch vessel diameter greater than 5 mm
* Iliac artery distal fixation site
* An inside diameter of 8mm - 13mm and a length of ≥ 10mm or
* an inside diameter of \> 13mm - 20mm and a length of ≥ 15mm
* Age: ≥50 years old
Exclusion Criteria:
* Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
* Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
* Unwilling to comply with the follow-up schedule
* Inability or refusal to give informed consent by subject or legal representative
* Subject is pregnant…
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
Proportion of study subjects with treatment success at 1 year