Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

N/AActive Not RecruitingNCT06094127

Cook Research Incorporated300 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Thoracic Aortic Aneurysm Penetrating Aortic Ulcer

Interventions

Endovascular aortic treatmentDEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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).

Locations (10)

CHU Dijon Bourgogne

Dijon, France

Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph

Le Plessis-Robinson, France

Centre Hospitalier Regional Universitaire de Lille

Lille, France

Outcomes

Primary Outcomes

freedom from aortic-disease-related mortality

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

Time frame: 5 years

Data from ClinicalTrials.gov

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