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This study aims to gather real-world clinical data demonstrating the continued safety and performance of the a marketed stent graft (Zenith® Alpha Thoracic Endovascular Graft [ZTA]) and collect longer term follow-up to better understand clinical outcomes associated with the expected lifetime of the device.
Per local regulations, this study includes both retrospective and prospective patients. Patients can be included retrospectively if they are treated with the study device from 01 January 2019 until the study site is eligible for prospective enrollment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular aortic treatment | Device | Use of ZTA to treat diseases in the descending thoracic aorta, such as thoracic aortic aneurysm and penetrating aortic ulcer. |
| Measure | Description | Time Frame |
|---|---|---|
| freedom from aortic-disease-related mortality | Death from aortic rupture; death from any cause occurring within 30 days of the index procedure or a secondary intervention; or any death determined to be related to the treated aortic disease | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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This study will collect clinical data on patients treated with ZTA. Data from at least 300 eligible patients will be collected, among them a minimum of 196 patients with primary pathology being aneurysm or penetrating aortic ulcer of the descending thoracic aorta. Patients treated with ZTA will be consecutively enrolled in the study and the enrollment of all patients will be completed at maximum year after site activation
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| Name | Affiliation | Role |
|---|---|---|
| Nikolaos Tsilimparis, MD | Klinikum der Universitat Munchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Dijon Bourgogne | Dijon | 21079 | France | |||
| Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph |
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| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D000094667 | Penetrating Atherosclerotic Ulcer |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| Le Plessis-Robinson |
| 92350 |
| France |
| Centre Hospitalier Regional Universitaire de Lille | Lille | 59000 | France |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Universitätsklinikum der LMU München | München | 81377 | Germany |
| St. Franzikus Hospital Munster | Münster | 48145 | Germany |
| IRCCS-University Hospital Sant'Orsolo Polyclinic | Bologna | 40138 | Italy |
| IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| Maastricht University Medical Center | Maastricht | 6202 AZ | Netherlands |
| Radboud UMC | Nijmegen | 6500 HB | Netherlands |
| D000094683 |
| Acute Aortic Syndrome |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |