A Multicenter, observational Data Collection Study to Evaluate the Safety and Performance of the Nexus™ Aortic Arch Stent Graft System in patients that were implanted with the device as part of Compassionate Use Procedures.
The purpose of the study is to collect and analyze data that is recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use Procedures.The data will be used to obtain additional information on the safety and performance of the Nexus™ Aortic Arch Stent Graft System in patients affected by pathologies involving the aortic arch. Data will be collected at each time point of patient's follow up conducted according to the standard of care in each site.
Study Type
OBSERVATIONAL
Enrollment
7
Retrospective collection of data recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use duly authorized according to country specific regulations.
Ospedale San Filippo Neri
Rome, Lazio, Italy
ADHB Charitable Trust
Auckland, New Zealand
Klinik Hirslanden
Zurich, Switzerland
Zurich University Hospital
Zurich, Switzerland
Primary Safety Evaluation Criteria
Device related mortality at 30 days post implantation based on review of medical charts by the Investigators
Time frame: within 30 days post implantation
Performance Evaluation Criteria
Successful disease treatment at 30 days post implantation, defined as Stent Graft positioned in the aortic arch isolating the diseased lesion based on review of medical charts by the Investigators.
Time frame: within 30 days post implantation
Secondary Safety Evaluation Criteria
Device related re-intervention (e.g. due to endoleak, stent graft occlusion, clinically significant migration) within 1 year from implantation and based on review of medical charts by the Investigators.
Time frame: within 1 year post-implantation
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