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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD) | All patients who signed informed consent and are used with Ankura™ TAA Stent Graft Systems will undergo follow-up (FU) evaluations as per local hospital standards and corresponding IFU which is expected to be at the following time points post-implant: Before discharge, 30days after the procudure, 3-6 months after the Procedure, 12 months after the procedure, 24 months after the procedure, 36 months after the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ankura™ TAA Stent Graft System | Device | All patients will be implanted with Ankura™ TAA Stent Graft System in accordance with the instructions for use (IFU). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse events | Incidence of major adverse events. | Timeframe: within 30-day post-implantation |
| Freedom from stent graft-related events | Freedom from stent graft-related events (12 months) | Timeframe: within 12-month post-implantation |
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Inclusion Criteria:
Patient has descending thoracic aortic aneurysm (DTA) or type B aortic dissection (TBAD), who needs endovascular repair (TEVAR).
Life expectancy > 1 year.
Patient or legally authorized representative understands the nature of the clinical trial, agrees to its provisions, agrees to comply with the requirements of the study including a 3-year follow-up, and signed applicable Informed Consent Form.
Patient's characteristics consistent with Ankura™ Stent Graft System IFU and sizing guidelines, which indicate as following:
For descending thoracic aortic aneurysm (DTA) patient:
For type B aortic dissection (TBAD) patient:
Exclusion Criteria:
Patient with any contraindications mentioned in the Ankura™ Stent Graft System IFU:
Patient with traumatic aortic injury;
Patient with uncorrectable coagulopathy;
Patient with hereditary connective tissue disease, including but not limited to Marfan Syndrome or Ehlers-Danlos Syndrome;
Patient with morbid obesity, weight greater than 350 Pounds (150kg), or who cannot undergo accurate fluoroscopy examination due to obesity;
Age<18 Years or Age> 85 Years;
Pregnant or plan to be pregnant or breast feeding;
Myocardial infarction or stroke within 3 months prior to the procedure;
American Society of Anesthesiologists Physical Status Classification (ASA) classification 5 or higher;
Patient with an unstable angina pectoris or hearth insufficiency New York Heart Association Functional Classification (NYHA) 3 or 4
Participant in other drug or medical device clinical trials;
Patient with access vessel which are to tortuous, narrow or any kind of reasons that would lead to failure of introduction and advancing an introducer sheath;
Any condition (medical or anatomic) which makes the patient not suitable for endovascular repair according to the opinion of the investigator.
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Patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD) and indicate for endovascular repair (TEVAR).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asklepios Klinik Nord Heidberg | Hamburg | Germany | ||||
| St. Franziskus Hospital Münster |
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| Münster |
| Germany |
| Evaggelismos General Hospital | Athens | Greece |
| 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) |
| Ankara University Hospital Heart Center | Ankara | Turkey (Türkiye) |
| Erzurum University Hospital | Erzurum | Turkey (Türkiye) |
| Eskişehir City Hospital | Eskişehir | Turkey (Türkiye) |
| Gaziantep City Hospital | Gaziantep | Turkey (Türkiye) |
| Izmir City Hospital | Izmir | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D000094629 | Dissection, Thoracic Aorta |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D000784 | Aortic Dissection |
| D000094665 | Dissection, Blood Vessel |
| D000094683 | Acute Aortic Syndrome |
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