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

Active, not recruiting

• Conditions: Aortic Dissection

• Registration Number: NCT03707743
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-16
• Study Start: 2018-10-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical success of the STABILISE procedure	30 day	patency of visceral vessels and iliac arteries
Clinical success	30 day	absence of major adverse events (mortality, neurological complications, cardiological complications, respiratory complications, intestinal ischemia

Trial Locations

Locations (34)

ASST Lecco; 🇮🇹 Lecco, Italy

AOU Modena; 🇮🇹 Modena, Italy

AOU Policlinico Umberto I; 🇮🇹 Roma, Italy

Ospedale Civile SS. Annunziata; 🇮🇹 Sassari, Italy

AOUI Verona; 🇮🇹 Verona, Italy

Maastricht Heart+Vascular Center; 🇳🇱 Maastricht, Netherlands

Waikato Hospital; 🇳🇿 Hamilton, New Zealand

Bristish Hospital XXI / Instituto Cardiovascular de Lisboa; 🇵🇹 Lisboa, Portugal

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Catalonia, Spain

University of Lund, General Hospital, Malmö; 🇸🇪 Malmö, Sweden

University School of Medicine Department of Cardiovascular Surgery; 🇹🇷 Ankara, Turkey

Royal Brompton & Harefield NHS Foundation; 🇬🇧 Chelsea, London, United Kingdom

London Guy's & St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom

Falk Cardiovascular Research Center; 🇺🇸 Stanford, California, 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

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

St Vincent's Private Hospital Melbourne; 🇦🇺 Melbourne, Victoria, Australia

Austin Hospital Heidelberg; 🇦🇺 Victoria Park, Australia

Centervasc-Rio; 🇧🇷 Rio De Janeiro, Brazil

Hopital de la Timone; 🇫🇷 Marseille, France

Klinikum Nürnberg Süd; 🇩🇪 Nürnberg, Franconia, Germany

German Aortic Center Hamburg; 🇩🇪 Amburgo, Hamburg, Germany

Knight Cardiovascular Institute; 🇺🇸 Portland, Oregon, United States

Herz Im Zentrum; 🇦🇹 Neulengbach, Hauptplatz, Austria

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Universitätsklinikum Münster; 🇩🇪 Münster, Renania Settentrionale-Vestfalia, Germany

Johannes Gutenberg-University; 🇩🇪 Hamburg, Germany

Ospedale San Giovanni di Dio; 🇮🇹 Firenze, Italy

IRCCS San Raffaele Hospital; 🇮🇹 Milano, Italy