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New Stent-Graft shows promise for tough aneurysm cases

NCT ID NCT05609539

Disease control Sponsor: Azienda Ospedaliero-Universitaria di Modena Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a specially designed stent-graft for people with abdominal aortic aneurysms (a bulging blood vessel in the belly) that have a difficult shape near the kidney arteries. Fifty patients received the custom device to see if it could safely seal the aneurysm and keep blood flowing properly. The goal was to improve treatment for those who may not be good candidates for standard stent-grafts.

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.

Participants

50 people

The number who actually took part.

Started

Feb 2023

Finished

Sep 2025

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.

Who is studied

Adult patients fit to plead and with a diagnosis of AAA \> 50mm with a mismatched takeoff of tthe renal arteries. All the patients must be fit to ever with a standard endoggraft and must be able to carry out adhere the follow-up requested

Ages

18 years and older

Sex

Anyone

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: * Patients affected by infrarenal AAA \> 50mm * Treated in election for non-symptomatic AAA * Anatomy inside Treo (Terumo Aortic) instruction to use (IFU) * Distance between renal arteries \>10mm on aortic center-lumen-line * Age \> 18 * Patient fit to plead * Both sex * Written informed consent * Treated in the coordinator center or in one of the study's participating centers * Minimum follow-up requested: 3-months, 12-18 months and 5-years CTA; clinical and DUS examination at 6- and 12- and 36-months after the intervention and yearly thereafter Exclusion Criteria: * Patients with aortic pathologies different from AAA (aortic ulcers, dissection, pseudo-aneurysm etc) * Treated in urgent/emergent setting for symptomatic or ruptured AAA * AAA \< 50mm * Outside TREO (Terumo Aortic) IFU * With an inter-renal distance measured of the center-lumen-line \<10mm * Age \<18 * Unfit to plead * Refused to sign the informed consent * Treated outside the coordinator centers or in one of the study's participating center's * Refusal to adhere to the requested follow-up

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abdominal aortic aneurysm

Contacts and locations

Locations

  • AOU di Modena

    Baggiovara, Modena, 41126, Italy

More trials for these conditions

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