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The goal of this observational study is to collect clinical information on how safe, and how well the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System work for the treatment of aortic aneurysms, in the standard-of-care setting.
The main question[s] it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEXUS Aortic Arch Stent Graft System | |||
| Custom-made NEXUS Multibranch™ Aortic Arch Stent Graft System |
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| Measure | Description | Time Frame |
|---|---|---|
| Mortality | The primary outcome in this study is early mortality, defined as lesion related death or any death that occurs within 30-days post-procedure or within initial hospitalization following the index procedure (whichever occurs last), unless there is evidence of accidental or self-inflicted death | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All-cause death events will be counted | 12 months |
| Major Adverse Event (MAE) | Occurrence of at least one of the following MAEs at 30 days and 1 year post NEXUS implantation
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Patients diagnosed with a thoracic aortic aneurysm or chronic dissection extending to or involving the aortic arch and who are considered candidates for the endovascular repair.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natali Yosef | Contact | +972507599447 | natali@endospan.com | |
| Jessica Kleine | Contact | +16122800208 | j.kleine@endospan.com |
| Name | Affiliation | Role |
|---|---|---|
| Hubert Schelzig, MD | University Hospital Duesseldorf, University Clinic for Vascular and Endovascular Surgery | Principal Investigator |
| Augusto D'Onofrio | Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint Luc | Recruiting | Brussels | 1200 | Belgium |
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| 30 days and 12 months |
| Device failure | Device Failure will be assessed via the following outcomes:
| Procedure, 30 days, 12 months |
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| Aretaieio Hospital | Recruiting | Nicosia | Cyprus | 2024 | Cyprus |
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| APHP Henri Mondor | Recruiting | Paris | France |
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| Hôpital Européen Georges Pompidou | Recruiting | Paris | France |
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| Immanuel Klinikum Brandenburg, Herzzentrum Brandenburg | Recruiting | Bernau bei Berlin | Brandenburg | 16321 | Germany |
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| University Hospital Duesseldorf | Recruiting | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
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| German Heart Center | Recruiting | Berlin | Germany |
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| University Hospital Bonn | Recruiting | Bonn | Germany |
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| Evaggelismos General Hospital | Recruiting | Athens | Greece |
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| Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia | Not yet recruiting | Brescia | 25123 | Italy |
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| University Hospital Padoua | Recruiting | Padova | Italy |
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| Stichting Amsterdam UMC, | Recruiting | Amsterdam | 1081 | Netherlands |
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| University Medical Center Groningen | Not yet recruiting | Groningen | Netherlands |
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| Medical University of Warsaw | Recruiting | Warsaw | Poland |
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| Hospital Universitario Puerta del Mar | Recruiting | Cadiz | Andalusia | 11009 | Spain |
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| Hospital Alvaro Cunqueiro Vigo | Recruiting | Vigo | Galicia | 36312 | Spain |
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| Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich | Recruiting | Zurich | Switzerland |
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