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Clinical Trials in Germany / NCT03707743
Active, not recruiting Observational

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

NCT03707743 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2018-10-30
Last updated
2026-01-15

Condition(s) studied

Aortic Dissection

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
Falk Cardiovascular Research Center Stanford California
Hartford Hospital Hartford Connecticut
Beth Israel Deaconess Medical Center Boston Massachusetts
Cooper University Health Care Camden New Jersey
Columbia University Irving Medical Center New York New York
Mayo Clinic Rochester New York
UNC Hospitals Chapel Hill North Carolina
Providence Heart and Vascular Institute Portland Oregon
Knight Cardiovascular Institute Portland Oregon
Austin Hospital Heidelberg Victoria Park Australia
St Vincent's Private Hospital Melbourne Melbourne Victoria
Herz Im Zentrum Neulengbach Hauptplatz
Centervasc-Rio Rio de Janeiro Brazil
Hopital de la Timone Marseille France
Hôpital Européen Georges Pompidou Paris Paris
Klinikum Nürnberg Süd Nuremberg Franconia
German Aortic Center Hamburg Hamburg Free and Hanseatic City of Hamburg
Johannes Gutenberg-University Hamburg Germany
Universitätsklinikum Münster Münster North Rhine-Westphalia
ASST Lecco Lecco Italy
IRCCS San Raffaele Hospital Milan Italy
AOU Modena Modena Italy
AOU Policlinico Umberto I Roma Italy
Ospedale San Giovanni di Dio Florence 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 Lisbon Portugal
Hospital Clínic de Barcelona Barcelona Catalonia
University of Lund, General Hospital, Malmö Malmö Sweden
University School of Medicine Department of Cardiovascular Surgery Ankara Turkey (Türkiye)
Royal Brompton & Harefield NHS Foundation Chelsea London
London Guy's & St Thomas' NHS Foundation Trust London London

More IRCCS San Raffaele trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03707743 on ClinicalTrials.gov ↗ ← All trials in Germany