NCT06094127

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
104mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
4 countries

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jul 2023Dec 2034

Study Start

First participant enrolled

July 6, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2034

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

6.4 years

First QC Date

October 17, 2023

Last Update Submit

February 25, 2026

Conditions

Thoracic Aortic AneurysmPenetrating Aortic Ulcer

Keywords

AneurysmThoracicDescendingAortaStent-graft

Outcome Measures

Primary Outcomes (1)

  • 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

    5 years

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 Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will collect clinical data on patients treated with ZTA. Data from at least 300 eligible patients will be collected, among them a minimum of 196 patients with primary pathology being aneurysm or penetrating aortic ulcer of the descending thoracic aorta. Patients treated with ZTA will be consecutively enrolled in the study and the enrollment of all patients will be completed at maximum year after site activation

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph

Le Plessis-Robinson, 92350, France

Location

Centre Hospitalier Regional Universitaire de Lille

Lille, 59000, France

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Universitätsklinikum der LMU München

München, 81377, Germany

Location

St. Franzikus Hospital Munster

Münster, 48145, Germany

Location

IRCCS-University Hospital Sant'Orsolo Polyclinic

Bologna, 40138, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Maastricht University Medical Center

Maastricht, 6202 AZ, Netherlands

Location

Radboud UMC

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Aortic Aneurysm, ThoracicPenetrating Atherosclerotic UlcerAneurysm

Condition Hierarchy (Ancestors)

Aortic AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesAcute Aortic SyndromeArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Nikolaos Tsilimparis, MD

    Klinikum der Universitat Munchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 23, 2023

Study Start

July 6, 2023

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2034

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

DE(3)NL(2)FR(3)IT(2)