The NEXUS™ Compassionate Use Data Collection Study
- Conditions
- Aortic Arch Aneurysm
- Registration Number
- NCT03420066
- Lead Sponsor
- Endospan Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- Patients for whom the Nexus implantation was initiated as part of a compassionate use procedure.
- A signed and dated Informed Consent document is available that authorizes to collect the patient's personal data following implantation of the Nexus systems and throughout the follow ups visits up to 5 years following implantation.
-There are no exclusions. Data will be collected for all implanted population as described in the inclusion section above
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Safety Evaluation Criteria within 30 days post implantation Device related mortality at 30 days post implantation based on review of medical charts by the Investigators
Performance Evaluation Criteria within 30 days post implantation 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.
- Secondary Outcome Measures
Name Time Method Secondary Safety Evaluation Criteria within 1 year post-implantation 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.
Trial Locations
- Locations (4)
Ospedale San Filippo Neri
🇮🇹Roma, Lazio, Italy
ADHB Charitable Trust
🇳🇿Auckland, New Zealand
Klinik Hirslanden
🇨🇭Zürich, Switzerland
Zurich University Hospital
🇨🇭Zürich, Switzerland
Ospedale San Filippo Neri🇮🇹Roma, Lazio, Italy