The purpose of this study is to collect clinical data on patient outcomes, evaluate the safety and performance of Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire, and build clinical evidence for patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD).
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee
Study Type
OBSERVATIONAL
Enrollment
147
All patients will be implanted with Ankura™ TAA Stent Graft System in accordance with the instructions for use (IFU).
Asklepios Klinik Nord Heidberg
Hamburg, Germany
St. Franziskus Hospital Münster
Münster, Germany
Evaggelismos General Hospital
Athens, Greece
Incidence of major adverse events
Incidence of major adverse events.
Time frame: Timeframe: within 30-day post-implantation
Freedom from stent graft-related events
Freedom from stent graft-related events (12 months)
Time frame: Timeframe: within 12-month post-implantation
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General Hospital of Athens - Georgios Gennimatas
Athens, Greece
University General Hospital - Attikon
Attiki, Greece
A.O. Ordine Mauriziano di Torino
Turin, Italy
Petrovsky National Research Centre of Surgery
Moscow, Russia
Federal State Budgetary Institution - V.A. Almazov National Medical Research Centre
Saint Petersburg, Russia
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye)
...and 5 more locations