Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

NCT06094127 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Cook Research Incorporated

Phase

Observational

Started

2023-07-06

Last updated

2026-02-27

Condition(s) studied

Thoracic Aortic AneurysmPenetrating Aortic Ulcer

Investigational drug(s) / intervention(s)

Endovascular aortic treatment

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

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

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).

Primary outcome measure(s)

freedom from aortic-disease-related mortality — 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

Trial sites (10)

Facility	City	Region
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
Universitätsklinikum Hamburg-Eppendorf	Hamburg	Germany
Universitätsklinikum der LMU München	München	Germany
St. Franzikus Hospital Munster	Münster	Germany
IRCCS-University Hospital Sant'Orsolo Polyclinic	Bologna	Italy
IRCCS Ospedale San Raffaele	Milan	Italy
Maastricht University Medical Center	Maastricht	Netherlands
Radboud UMC	Nijmegen	Netherlands

Other trials for the same condition

Trajectory of Neuroinflammatory Markers in Cerebrospinal Fluid Prior to and After Thoracic Aortic Surgery Recruiting

Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries Active, not recruiting

Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis Active, not recruiting

Terumo Aortic Global Endovascular Registry Recruiting

Thoraflex Hybrid Post-Market Study Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06094127 on ClinicalTrials.gov ↗ ← All trials in the Netherlands