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NCT Number: NCT06094127

Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Thoracic Aortic Aneurysm Acute Aortic Syndrome Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Penetrating Aortic Ulcer Penetrating Atherosclerotic Ulcer Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne, Dijon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Endovascular aortic treatment

Device

Use of ZTA to treat diseases in the descending thoracic aorta, such as thoracic aortic aneurysm and penetrating aortic ulcer.

Primary outcomes

  1. freedom from aortic-disease-related mortality

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

A Post-market Clinical Follow up Study on Cook Medical Zenith® Alpha Thoracic Endovascular Grafts

Important dates

Study start
2023
Primary completion
2029
Study completion
2034
First posted
Oct 23, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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