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Custom Stent-Graft aims to fix aortic aneurysms without open surgery

NCT ID NCT07611968

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

50 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

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Other studies related to the condition(s) this trial covers.