Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

Launched by COOK RESEARCH INCORPORATED · Oct 20, 2023

Keywords

ClinConnect Summary

The Zenith Thoracic Alpha (ZTA) study is looking to collect information about the safety and effectiveness of a medical device called the Zenith® Alpha Thoracic Endovascular Graft (ZTA). This device is designed to treat conditions affecting the aorta, which is a large blood vessel in the chest. The goal of this trial is to understand how well the device works over time and to gather real-world data on patients who have received it since January 2019.

If you or a loved one has been treated with the ZTA device and are interested in participating, you might be eligible for this study. To qualify, participants need to agree to take part in the study and provide consent. However, those who have received a custom-made graft during the same or a later procedure, or whose follow-up information is difficult to obtain (like living overseas), cannot join. Those who participate can expect to help researchers gather valuable information that could improve future treatments for similar conditions.

Gender

ALL

Eligibility criteria

• 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).