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Recruiting NCT05636527

Further Evaluation of Safety and Performance of the NEXUS™ Aortic Arch Stent Graft System

Conditions: AAT9

Sex: All
Enrollment: 30
Sponsor: Endospan Ltd.

Location: Germany

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:Early mortality, defined as lesion related death, or any death that occurs within 30 days following the procedureSafety outcomes throughout the studyDevice failure throughout the studyProcedural and hospitalisation informationParticipants will be treated per institutional standard of care that includes the following:Medical History, blood tests, ABI, Rutherford Classification, physical examination, CTA, ECG, Echocardiography, and neurological assessment at baselineCollection of procedural and hospitalisation informationFollow-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

Eligibility Criteria

The subject is indicated for implant of the NEXUS™ Aortic Arch System in accordance with the current IFU.The subject is able and willing to provide informed consent to participate in the study.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.In the opinion of the Investigator, life expectancy exceeds one yearThe subject is not pregnant or planning to become pregnant.In the physician's opinion, subject's renal function is stable for the NEXUS procedure.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 daysExclusion Criteria:-

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05636527). StuddyBuddy aggregates publicly available trial information.