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New study to determine best value treatment for major artery aneurysm

NCT ID NCT07096388

Knowledge-focused Sponsor: Prof. Andrea Kahlberg Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 5 times

Summary

This observational study will look back at past cases and follow new patients to compare two surgical methods for repairing aorto-iliac aneurysms (a bulge in the main artery in the belly and pelvis). One method uses a standard surgical graft, the other uses a special stent that preserves blood flow to the pelvis. The goal is to see which approach works better and costs less over time. About 300 adults will take part, and the study will track complications, reoperations, and overall costs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors and health systems choose the most effective and cost-efficient procedure for treating aorto-iliac aneurysms.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection. It is not designed to prove one treatment is better, only to compare real-world outcomes and costs.

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

About 300 people

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

Started

Apr 2026

Expected to finish

Mar 2030

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.

Who is studied

Patients affected by an aorto-iliac aneurysm

Ages

18 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: * Patients affected by an aorto-iliac aneurysm who received an elective open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft) or endovascular repair (with Iliac Branch Endoprosthesis) * Adult patients ≥18 years * Patients able to understand and sign the informed consent approved by the Ethics Committee of San Raffaele Hospital Exclusion Criteria: * Patients treated with a hybrid approach (concomitant open surgical and endovascular treatment) * Patients treated with other endovascular techniques besides branched technology (e.g., physician-modified endografts, parallel grafts) * Patients already submitted to prior open or endovascular repair for aorto-iliac aneurysm/prior aorto iliac aneurysm sac embolization * Patients treated in urgent/emergent setting

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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.

Aorto-iliac aneurysm

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

  • IRCCS San Raffaele Hospital

    RECRUITING

    Miano, Italy, 20132, Italy

More trials for these conditions

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