NCT05636527 Further Evaluation of Safety and Performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS Multibranch™ Aortic Arch Stent Graft System
| NCT ID | NCT05636527 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Endospan Ltd. |
| Condition | AAT9 |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2022-11-09 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2022-11-09 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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: * Early mortality * Safety outcomes throughout the study * Device failure throughout the study * Procedural and hospitalisation information Participants will be treated per institutional standard of care Follow-up information will be collected through to five years.
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
Contact & Investigator
Hubert Schelzig, MD
PRINCIPAL INVESTIGATOR
University Hospital Duesseldorf, University Clinic for Vascular and Endovascular Surgery
Frequently Asked Questions
Who can join the NCT05636527 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AAT9. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05636527 currently recruiting?
Yes, NCT05636527 is actively recruiting participants. Contact the research team at natali@endospan.com for enrollment information.
Where is the NCT05636527 trial being conducted?
This trial is being conducted at Brussels, Belgium, Leuven, Belgium, Nicosia, Cyprus, Paris, France and 11 additional locations.
Who is sponsoring the NCT05636527 clinical trial?
NCT05636527 is sponsored by Endospan Ltd.. The principal investigator is Hubert Schelzig, MD at University Hospital Duesseldorf, University Clinic for Vascular and Endovascular Surgery. The trial plans to enroll 70 participants.