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Aortic Stent-Graft safety under the microscope: 600-Patient european registry launches

NCT ID NCT05896397

Knowledge-focused Sponsor: Cook Research Incorporated 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study is collecting information from 600 patients across Europe who receive custom-made stent-grafts from Cook to treat complex aortic aneurysms or chronic aortic dissections. The goal is to see how well these devices work in everyday medical practice and to track any major complications. No new treatment is being tested—instead, researchers are gathering real-world data to support device safety and future improvements.

What this could mean

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

Active substance
Custom-made stent-graft devices (endovascular grafts)
What this could lead to
If successful, this study could help improve the safety and design of custom stent-grafts for treating complex aortic diseases.
What could go wrong
This is an observational data collection study, not a controlled trial, so it cannot prove cause and effect. Results depend on real-world variability and may not apply to all patients.

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 600 people

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

Started

May 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 receiving a Cook custom made endovascular graft within the scope of the study in a maximum of 20 clinical sites in Europe.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1\. Patients who will be treated with a Cook CMD Exclusion Criteria: 1. Patients who declare they are unable to complete clinical follow-up visit at the time of enrollment, or 2. Patients or his/her legally authorized representative objects to extraction of patient's data from the medical record, or unwilling to sign the Informed Consent.

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm Aneurysm, Aortic Arch aortic aneurysm Aortic Aneurysm, Thoracoabdominal Aortic Dissection thoracic aortic aneurysm

As listed by the trial registrant

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

Aortic arch aneurysm Chronic aortic dissection Complex abdominal aortic aneurysm Thoracoabdominal aortic aneurysm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 6 countries. 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

  • Aarhus University Hospital

    RECRUITING

    Aarhus, Denmark, 8200, Denmark

  • CHU de Lille

    RECRUITING

    Lille, 59037, France

  • Hopital Marie Lannelongue

    RECRUITING

    Le Plessis-Robinson, 92350, France

  • IRCCS San Raffaele Hospital

    RECRUITING

    Milan, 20132, Italy

  • Klinnikum Nurnberg

    RECRUITING

    Nuremberg, Germany, 90471, Germany

  • LMU Klinikum Munich

    RECRUITING

    Munich, Germany, 80337, Germany

  • North Bristol NHS Trust

    RECRUITING

    Bristol, BS10 5NB, United Kingdom

  • Orsola Maplighi

    RECRUITING

    Bologna, Italy

  • Ospedal Policlinico San Martino-HSM

    RECRUITING

    Genova, 16132, Italy

  • PoliclinicoS Orsola Malpighi

    RECRUITING

    Bologna, 40138, Italy

  • Rigshospitalet

    RECRUITING

    Copenhagen, Denmark, 2100, Denmark

  • Skane University Hospital Malmo

    RECRUITING

    Malmö, SE-205-02, Sweden

  • St Barthowlomew's

    RECRUITING

    London, United Kingdom

  • St Thomas' Hospital

    RECRUITING

    London, SE1 9RT, United Kingdom

  • St. Franzikus-Hospital Munster

    RECRUITING

    Münster, Germany, 48145, Germany

  • University Hospital Hamburg Eppendorf

    RECRUITING

    Hamburg, Germany, 20251, Germany

  • University Hospitals Birmingham NHS Foundation Trust

    RECRUITING

    Birmingham, B9 5SS, United Kingdom

  • Uppsala University Hospital

    RECRUITING

    Uppsala, 75309, Sweden

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