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New registry tracks STABILISE procedure for aortic tears

NCT ID NCT03707743

Knowledge-focused Sponsor: IRCCS San Raffaele 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is collecting information from 200 patients who had a type of aortic dissection (a tear in the main artery) and were treated with a procedure called STABILISE. The goal is to see how well the technique works and what complications may occur. Participants are adults with acute or subacute aortic dissection. This is an observational registry, meaning no new treatment is given—just data is gathered to learn more.

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 200 people

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

Started

Oct 2018

Expected to finish

Dec 2026

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 with acute/subacute type B aortic dissection treated by means of the STABILISE technique

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 with ≥ 18 years of age; * Patients presenting with an acute (up to two weeks from the onset) and subacute (between 3 and 12 weeks from the onset) type B dissection with a proximal suitable non-dissected landing zone in the aortic arch or descending thoracic aorta (supra-aortic trunks debranching may be employed to obtain an adequate proximal landing zone); * Total aortic diameter of the abdominal aorta (from supra-celiac to infra-renal level) must not exceed 42 mm; * Patients able to sign specific informed consent for the study. Exclusion Criteria: * Patients with chronic type B aortic dissection (more than 12 weeks from the onset); * Patients with acute type B aortic dissection not treated according to the following treatment protocol; * Unwilling or unable to comply with the follow-up schedule; * Inability or refusal to give informed consent; * Simultaneously participating in another investigative device or drug study; * Frank rupture; * Systemic infection (eg, sepsis); * Allergy to stainless steel, polyester, solder (tin, silver), polypropylene, nitinol, or gold; * Untreatable reaction to contrast, which, in the opinion of the investigator, cannot be adequately premedicated; * Surgical or endovascular AAA repair within 30 days before or after dissection repair; * Previous placement of a thoracic endovascular graft; * Prior open repair involving the descending thoracic aorta, including the supra-renal aorta and/or arch; * Interventional and/or open surgical procedures (unrelated to dissection) within 30 days before or after dissection repair.

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Conditions

The condition(s) this trial relates to.

Aortic Dissection

As listed by the trial registrant

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

Aortic dissection

Contacts and locations

Locations

  • AOU Modena

    Modena, Italy, 41124, Italy

  • AOU Policlinico Umberto I

    Roma, Italy, 00161, Italy

  • AOUI Verona

    Verona, 37126, Italy

  • ASST Lecco

    Lecco, Italy, 23900, Italy

  • Austin Hospital Heidelberg

    Victoria Park, Australia, 3084, Australia

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Bristish Hospital XXI / Instituto Cardiovascular de Lisboa

    Lisbon, Portugal, 1600-209, Portugal

  • Centervasc-Rio

    Rio de Janeiro, Brazil, 22271-110, Brazil

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Cooper University Health Care

    Camden, New Jersey, 08103, United States

  • Falk Cardiovascular Research Center

    Stanford, California, 94305, United States

  • German Aortic Center Hamburg

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Herz Im Zentrum

    Neulengbach, Hauptplatz, 3040, Austria

  • Hopital de la Timone

    Marseille, France, 13385, France

  • Hospital Clínic de Barcelona

    Barcelona, Catalonia, 08036, Spain

  • Hôpital Européen Georges Pompidou

    Paris, Paris, 75015, France

  • IRCCS San Raffaele Hospital

    Milan, Italy, 20132, Italy

  • Johannes Gutenberg-University

    Hamburg, Germany, 55122, Germany

  • Klinikum Nürnberg Süd

    Nuremberg, Franconia, 90471, Germany

  • Knight Cardiovascular Institute

    Portland, Oregon, 97239, United States

  • London Guy's & St Thomas' NHS Foundation Trust

    London, London, SE1 9RT, United Kingdom

  • Maastricht Heart+Vascular Center

    Maastricht, Netherlands, 6229HX, Netherlands

  • Mayo Clinic

    Rochester, New York, 55902, United States

  • Ospedale Civile SS. Annunziata

    Sassari, Italy

  • Ospedale San Giovanni di Dio

    Florence, Italy

  • Providence Heart and Vascular Institute

    Portland, Oregon, 97225, United States

  • Royal Brompton & Harefield NHS Foundation

    Chelsea, London, SW3 6NP, United Kingdom

  • St Vincent's Private Hospital Melbourne

    Melbourne, Victoria, 3002, Australia

  • UNC Hospitals

    Chapel Hill, North Carolina, 27514, United States

  • University School of Medicine Department of Cardiovascular Surgery

    Ankara, Turkey (Türkiye)

  • University of Lund, General Hospital, Malmö

    Malmö, Sweden, Sweden

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149, Germany

  • Waikato Hospital

    Hamilton, New Zealand

More trials for these conditions

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