Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique (STABILISE) (STABILISE)

January 14, 2026 updated by: Germano Melissano, IRCCS San Raffaele

A Physician-initiated, International, Multi-center, Prospective and Retrospective, Non Randomized, Observational Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique.

The aim of the study is to evaluate results of patients treated with the STABILISE technique for acute/subacute aortic dissection. Results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Australia
      • Victoria Park, Australia, Australia, 3084
        • Austin Hospital Heidelberg
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • St Vincent's Private Hospital Melbourne
  • Austria
    • Hauptplatz
      • Neulengbach, Hauptplatz, Austria, 3040
        • Herz Im Zentrum
  • Brazil
    • Brazil
      • Rio de Janeiro, Brazil, Brazil, 22271-110
        • Centervasc-Rio
  • France
    • France
      • Marseille, France, France, 13385
        • Hôpital de la Timone
    • Paris
      • Paris, Paris, France, 75015
        • Hôpital Européen Georges Pompidou
  • Germany
    • Franconia
      • Nuremberg, Franconia, Germany, 90471
        • Klinikum Nurnberg Sud
    • Germany
      • Hamburg, Germany, Germany, 55122
        • Johannes Gutenberg-University
    • Hamburg
      • Hamburg, Hamburg, Germany, 20246
        • German Aortic Center Hamburg
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Universitatsklinikum Munster
  • Italy
      • Florence, Italy
        • Ospedale San Giovanni di Dio
      • Sassari, Italy
        • Ospedale Civile SS. Annunziata
      • Verona, Italy, 37126
        • AOUI Verona
    • Italy
      • Lecco, Italy, Italy, 23900
        • ASST Lecco
      • Milan, Italy, Italy, 20132
        • IRCCS San Raffaele Hospital
      • Modena, Italy, Italy, 41124
        • AOU Modena
      • Roma, Italy, Italy, 00161
        • AOU Policlinico Umberto I
  • Netherlands
    • Netherlands
      • Maastricht, Netherlands, Netherlands, 6229HX
        • Maastricht Heart+Vascular Center
  • New Zealand
      • Hamilton, New Zealand
        • Waikato Hospital
  • Portugal
    • Portugal
      • Lisbon, Portugal, Portugal, 1600-209
        • Bristish Hospital XXI / Instituto Cardiovascular de Lisboa
  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Hospital Clinic de Barcelona
  • Sweden
    • Sweden
      • Malmo, Sweden, Sweden
        • University of Lund, General Hospital, Malmö
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • University School of Medicine Department of Cardiovascular Surgery
  • United Kingdom
    • London
      • Chelsea, London, United Kingdom, SW3 6NP
        • Royal Brompton & Harefield NHS Foundation
      • London, London, United Kingdom, SE1 9RT
        • London Guy's & St Thomas' NHS Foundation Trust
  • United States
    • California
      • Stanford, California, United States, 94305
        • Falk Cardiovascular Research Center
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Health Care
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
      • Rochester, New York, United States, 55902
        • Mayo Clinic
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Hospitals
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Heart and Vascular Institute
      • Portland, Oregon, United States, 97239
        • Knight Cardiovascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Technical success of the STABILISE procedure
Time Frame: 30 day
patency of visceral vessels and iliac arteries
30 day
Clinical success
Time Frame: 30 day
absence of major adverse events (mortality, neurological complications, cardiological complications, respiratory complications, intestinal ischemia
30 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS San Raffaele

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Germano Melissano, MD, IRCCS San Raffaele Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STABILISE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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