Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

Sponsor

Cook Research Incorporated (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06094127

Collaborator

(none)

300

Enrollment

Locations

134.9

Anticipated Duration (Months)

100

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Aortic Aneurysm Penetrating Aortic Ulcer	Device: Endovascular aortic treatment

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jul 6, 2023

Anticipated Primary Completion Date :

Oct 1, 2029

Anticipated Study Completion Date :

Oct 1, 2034

Outcome Measures

Primary Outcome Measures

Freedom from aneurysm-related mortality [5 years]
Death related to aneurysm

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph	Le Plessis-Robinson	France	92350
2	Centre Hospitalier Regional Universitaire de Lille	Lille	France	59000
3	St. Franzikus Hospital Munster	Münster	Germany	48145