NCT06094127

Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Cook Research Incorporated · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Thoracic Aortic Aneurysm
• Penetrating Aortic Ulcer

Interventions

Type	Name	Description
DEVICE	Endovascular aortic treatment	Use of ZTA to treat diseases in the descending thoracic aorta, such as thoracic aortic aneurysm and penetrating aortic ulcer.

Timeline

• Start date: 2023-07-06
• Primary completion: 2029-12-01
• Completion: 2034-12-01
• First posted: 2023-10-23
• Last updated: 2026-02-27

Locations

10 sites across 4 countries: France, Germany, Italy, Netherlands