Penetrating Aortic Ulcer, Thoracic Aortic Aneurysm
Conditions
Keywords
Aneurysm, Thoracic, Descending, Aorta, Stent-graft
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEndovascular aortic treatment
Use of ZTA to treat diseases in the descending thoracic aorta, such as thoracic aortic aneurysm and penetrating aortic ulcer.
Sponsors
Cook Research Incorporated
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient has been treated/was intended to be treated with ZTA according to the clinical practice from Jan 2019 until site initiation * The patient is willing to participate in the study and provide written informed consent for study participation or express non-objection or give written consent per local requirements prior to data collection of any data from medical records.
Exclusion criteria
* A patient treated with a custom-made fenestrated and/or branched endovascular graft in conjunction with ZTA either during the same procedure or in a staged procedure. * A patient whose follow-up data collection is not possible (e.g. due to living abroad).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| freedom from aortic-disease-related mortality | 5 years | 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 |
Countries
France, Germany, Italy, Netherlands
Contacts
PRINCIPAL_INVESTIGATORNikolaos Tsilimparis, MD
Klinikum der Universitat Munchen
Outcome results
None listed