Collecting data on the safety and performance of the Zenith Alpha Thoracic Endovascular Graft
A Post-market Clinical Follow up Study on Cook Medical Zenith® Alpha Thoracic Endovascular Grafts
This study is trying to see how safe and effective the Zenith Alpha Thoracic Endovascular Graft is for treating thoracic aortic aneurysms and penetrating aortic ulcers in real patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Cook Group Incorporated Industry-sponsored |
| Locations | 10 sites (Dijon and 9 other locations) |
| Trial ID | NCT06094127 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world clinical data on the safety and performance of the Zenith Alpha Thoracic Endovascular Graft (ZTA) for treating thoracic aortic aneurysms and penetrating aortic ulcers. It includes both retrospective and prospective patients, with retrospective data collection starting from January 2019 until the site is eligible for prospective enrollment. The study will help understand the long-term clinical outcomes associated with the device's expected lifetime.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have been treated or intended to be treated with the Zenith Alpha Thoracic Endovascular Graft since January 2019.
Not a fit: Patients who have received a custom-made fenestrated or branched endovascular graft in conjunction with ZTA may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of the ZTA device for patients with thoracic aortic conditions.
How similar studies have performed: Other studies have successfully gathered real-world data on similar endovascular devices, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Dijon and 9 other locations
- CHU Dijon Bourgogne — Dijon, France (Recruiting)
- Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph — Le Plessis-Robinson, France (Active_not_recruiting)
- Centre Hospitalier Regional Universitaire de Lille — Lille, France (Active_not_recruiting)
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (Active_not_recruiting)
- Universitätsklinikum der LMU München — München, Germany (Active_not_recruiting)
- St. Franzikus Hospital Munster — Münster, Germany (Active_not_recruiting)
- IRCCS-University Hospital Sant'Orsolo Polyclinic — Bologna, Italy (Active_not_recruiting)
- IRCCS Ospedale San Raffaele — Milano, Italy (Active_not_recruiting)
- Maastricht University Medical Center — Maastricht, Netherlands (Active_not_recruiting)
- Radboud UMC — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Nikolaos Tsilimparis, MD — Klinikum der Universitat Munchen
- Study coordinator: Lieve Geerts
- Email: lieve.geerts@cookmedical.com
- Phone: +32 478 82 89 41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.