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Study of Physician-Modified Terumo Treo Stent-Graft for Aortic Aneurysm

This study is looking at the safety and early effectiveness of a special device called the Physician-Modified Terumo Treo Abdominal Stent-Graft System. This device is used during surgery to fix certain types of aortic aneurysms (a bulging in the main artery of your body). You might be able to join if you are 50 years or older, have an aneurysm that is a certain size or has grown quickly, or is causing symptoms. The study aims to see how many people have successful treatment after one year. We are currently unclear on the recruitment status, but the study plans to include 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year to check for treatment success.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07611968

Prospective Evaluation of Physician Modified Endografts for Aortic Disease

Recruiting
NAAges 50+InterventionalTreatment
Mayo Clinic
~20 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Physician-Modified Terumo Treo Abdominal Stent-Graft System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of study subjects with treatment success at 1 year
Measured over 1 year

Conditions

Aortic Aneurysm

Explore related trials

Aortic Aneurysm

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Young Erben, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Pia Geisselmaier
[email protected]
904-953-2077
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of study subjects with treatment success at 1 year1 year

    Treatment success is defined as freedom from the following: * Aneurysm enlargement: \>5mm as compared to any previous CT measure using orthogonal (i.e., perpendicular to the centerline) measurements. * Aneurysm rupture * Aneurysm-related mortality * Conversion to open repair * Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events) * Graft infection * Disabling Stroke * Permanent dialysis Results are reported as a percentage