Custom Stent-Graft aims to fix aortic aneurysms without open surgery
NCT ID NCT07611968
First seen Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times
Summary
This study tests a stent-graft that doctors modify before use to treat complex aortic aneurysms. It involves 20 high-risk patients who cannot have standard open surgery. The goal is to see if the device is safe and prevents aneurysm growth or rupture.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Physician-Modified Terumo Treo Abdominal Stent-Graft System
- What this could lead to
- If successful, this could offer a less invasive treatment option for complex aortic aneurysms, reducing the need for open surgery.
- What could go wrong
- This is a small, early-stage study with only 20 participants, so results may not apply to everyone. There are risks like aneurysm rupture, stroke, or kidney failure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 or breastfeeding * Ruptured aneurysms * Prior aortic repair * Patient is eligible for treatment with an FDA-approved marketed device and patient can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution. * Known sensitivities or allergies to the materials of construction of the devices, including nitinol, polyester, PTFE, stainless steel, platinum/iridium, tantalum markers. * Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed * Uncorrectable coagulopathy * Body habitus that would inhibit x-ray visualization of the aorta or exceed the safe capacity of the equipment * Subject has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \< 30 days of endovascular repair * Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina) * Systemic or local infection that may increase the risk of endovascular graft infection * Baseline creatinine greater than 2.0 mg/dL * Thrombus or excessive calcification within the neck of the aneurysm * Branch stenosis \>50% not amenable to endovascular preparation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic
RECRUITINGJacksonville, Florida, 32224, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Laser-Cut stent grafts may offer new route for aortic aneurysm repair
- Can a Pre-Surgery fitness and support program boost recovery from aortic aneurysm repair?
- AI may spot dangerous aortic growth before it happens
- Can sound waves replace CT scans for aortic aneurysm monitoring?
- Can a new stent keep complex aortic aneurysms safely sealed?
- Can a stent-graft keep aortic aneurysms in check for years? a long-term follow-up study aims to find out.