ARCUS: Further Evaluation of Safety and Performance of the NEXUS™ Aortic Arch Stent Graft System
Study Details
Study Description
Brief Summary
The goal of this observational study is to collect more clinical information on how safe it is, and how well the NEXUS™ Aortic Arch Stent Graft System works for the treatment of aortic aneurysms, which is a bulg involving the aortic arch in the standard-of-care setting following CE-approval.
The main question[s] it aims to answer are:
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Early mortality, defined as lesion related death, or any death that occurs within 30 days following the procedure
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Safety outcomes throughout the study
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Device failure throughout the study
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Procedural and hospitalisation information
Participants will be treated per institutional standard of care that includes the following:
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Medical History, blood tests, ABI, Rutherford Classification, physical examination, CTA, ECG, Echocardiography, and neurological assessment at baseline
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Collection of procedural and hospitalisation information
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Follow-up information will be collected at discharge, after 30 days, after 6 months and annually through to five years. Data collected may include: AE/SAE, physical examination, AKI classification, neurological assessment, lab tests, CTA
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Detailed Description
The objective of the study is to collect and evaluate further early and long-term clinical safety and performance data of the NEXUS™ Aortic Arch Stent Graft System, for the treatment of thoracic aortic aneurysms involving the aortic arch, in the real-life standard of care setting, following CE mark approval in February 2019.
The NEXUS™ Aortic Arch Stent Graft System is indicated for the endovascular treatment of thoracic aortic diseases involving the aortic arch with proximal landing zone in ascending aorta and the Brachiocephalic artery. This includes:
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Aneurysm
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Dissecting aneurysm / dissection and intramural hematoma (IMH)
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False / Pseudo aneurysm if not infected
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Residual aneurysm/dissection following ascending aorta open repair
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Penetrating ulcer, if not infected
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 hospitalisation following the index procedure (whichever occurs last), unless there is evidence of accidental or self-inflicted death.
Data from the initial hospitalisation through to discharge, including medical history, disease diagnostics, procedural information will be obtained to applicable standard-of-care of the participating centres. Furthermore, safety and performance data will be collected through to five years. Follow-up visits are expected at 30 days, 6 months, 12 months and annually through to five years
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Thoracic Aortic Disease The NEXUS™ Aortic Arch Stent Graft System is indicated for the endovascular treatment of thoracic aortic diseases involving the aortic arch with proximal landing zone in ascending aorta and the Brachiocephalic artery. This includes: Aneurysm Dissecting aneurysm / dissection and intramural hematoma {IMH) False / Pseudo aneurysm if not infected Residual aneurysm/dissection following ascending aorta open repair Penetrating ulcer, if not infected |
Outcome Measures
Primary Outcome Measures
- Mortality [30 days]
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
Secondary Outcome Measures
- Mortality [12 months]
All-cause death events will be counted
- Major Adverse Event (MAE) [30 days and 12 months]
Occurrence of at least one of the following MAEs at 30 days and 1 year post NEXUS implantation Disabling Stroke Permanent Paralysis/Paraplegia Renal failure Aortic rupture Development of new dissections in the thoracic aorta or brachiocephalic artery
- Device failure [Procedure, 30 days, 12 months]
Device Failure will be assessed via the following outcomes: Peri-operative device failure Device occlusion Surgical conversion Re-Intervention to treat migration, Re-Intervention to treat stenosis or occlusion, Re-Intervention to treat type Ia, Ib, III, IV endoleaks Re-Intervention for loss of device integrity
Eligibility Criteria
Criteria
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The subject is indicated for implant of the NEXUS™ Aortic Arch System in accordance with the current IFU.
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The subject is able and willing to provide informed consent to participate in the study.
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Subject is not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
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In the opinion of the Investigator, life expectancy exceeds one year
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The subject is not pregnant or planning to become pregnant.
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In the physician's opinion, subject's renal function is stable for the NEXUS procedure.
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In the opinion of the investigator, subject does not have co-morbidities or planned surgeries that will interfere with the implant of the device, e.g., major cardiac surgery or interventional procedure in the last 90 days, MI or cerebral vascular accident (CVA) in the last 90 days
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Duesseldorf | Duesseldorf | North-Rhine-Westphalia | Germany | 40225 |
| 2 | Hospital Universitario Puerta del Mar | Cadiz | Andalucia | Spain | 11009 |
| 3 | Hospital Alvaro Cunqueiro Vigo | Vigo | Galicia | Spain | 36312 |
Sponsors and Collaborators
- Endospan Ltd.
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP010