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

Running, not enrolling

Conditions studied: Aortic Dissection

In brief

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

Key facts

Study ID

NCT03707743

Run by

IRCCS San Raffaele

People needed

200

Starts

2018-10-30

Expected to finish

2026-12-30

Last updated by the study team

2026-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Falk Cardiovascular Research Center — Stanford, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Cooper University Health Care — Camden, New Jersey, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Mayo Clinic — Rochester, New York, United States
• UNC Hospitals — Chapel Hill, North Carolina, United States
• Providence Heart and Vascular Institute — Portland, Oregon, United States
• Knight Cardiovascular Institute — Portland, Oregon, United States
• Austin Hospital Heidelberg — Victoria Park, Australia, Australia
• St Vincent's Private Hospital Melbourne — Melbourne, Victoria, Australia
• Herz Im Zentrum — Neulengbach, Hauptplatz, Austria
• Centervasc-Rio — Rio de Janeiro, Brazil, Brazil
• Hopital de la Timone — Marseille, France, France
• Hôpital Européen Georges Pompidou — Paris, Paris, France
• Klinikum Nürnberg Süd — Nuremberg, Franconia, Germany
• German Aortic Center Hamburg — Hamburg, Free and Hanseatic City of Hamburg, Germany
• Johannes Gutenberg-University — Hamburg, Germany, Germany
• Universitätsklinikum Münster — Münster, North Rhine-Westphalia, Germany
• ASST Lecco — Lecco, Italy, Italy
• IRCCS San Raffaele Hospital — Milan, Italy, Italy
• AOU Modena — Modena, Italy, Italy
• AOU Policlinico Umberto I — Roma, Italy, Italy
• Ospedale San Giovanni di Dio — Florence, Italy
• Ospedale Civile SS. Annunziata — Sassari, Italy

Full record on ClinicalTrials.gov

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