Further Evaluation of Safety and Performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System

Launched by ENDOSPAN LTD. · Nov 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of two types of devices, the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System, which are used to treat aortic aneurysms. An aortic aneurysm is a bulge in the aorta, the large artery that carries blood from the heart, which can be dangerous if it bursts. The trial aims to gather information about how well these devices work, how safe they are for patients, and any potential issues that may arise during treatment.

To participate in the study, candidates must be adults aged 18 or older who are eligible for the implant of one of these stent graft systems. Key criteria include having a stable health condition, not being pregnant, and not currently being involved in other conflicting studies. Participants will receive treatment according to standard medical practices and will be monitored for up to five years to collect information on their health outcomes. This study will help doctors understand the best ways to use these devices and improve care for patients with aortic aneurysms.

Gender

ALL

Eligibility criteria

• • 1. Male and female age ≥18 years
• • 2. The subject is indicated for implant of the NEXUS Aortic Arch System in accordance with the current IFU, or
• • 3. The subject is indicated for implant of the custom-made NEXUS DUO Aortic Arch System in accordance with the current IFU, or
• • 4. The subject has been already implanted, after February 2019, with the NEXUS or the NEXUS DUO according to the relevant IFU
• • 5. The subject is able and willing to provide informed consent to participate in the study.
• • 6. 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.
• • 7. In the opinion of the Investigator, life expectancy exceeds one year
• • 8. The subject is not pregnant or planning to become pregnant.
• • 9. In the physician's opinion, subject's renal function is stable for the NEXUS procedure.
• • 10. 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

Trial Officials