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Active (not recruiting) NCT03707743

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

Conditions: Aortic Dissection

Sponsor: IRCCS San Raffaele

trial.available_in: БГ
Overview
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
Who can participate
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.
Locations 13
Australia (1)
Austin Hospital Heidelberg
Victoria Park , Australia
Brazil (1)
Centervasc-Rio
Rio de Janeiro , Brazil
France (1)
Hopital de la Timone
Marseille , France
Germany (1)
Klinikum Nürnberg Süd
Nuremberg , Franconia
Italy (1)
ASST Lecco
Lecco , Italy
Netherlands (1)
Maastricht Heart+Vascular Center
Maastricht , Netherlands
New Zealand (1)
Waikato Hospital
Hamilton
Portugal (1)
Bristish Hospital XXI / Instituto Cardiovascular de Lisboa
Lisbon , Portugal
Spain (1)
Hospital Clínic de Barcelona
Barcelona , Catalonia
Sweden (1)
University of Lund, General Hospital, Malmö
Malmo , Sweden
Turkey (1)
University School of Medicine Department of Cardiovascular Surgery
Ankara
United Kingdom (1)
Royal Brompton & Harefield NHS Foundation
Chelsea , London
United States (1)
Falk Cardiovascular Research Center
Stanford , California
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.10.2018
Completion date
30.12.2026
Registry ID
NCT03707743
Source
anzctr
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