NEXUS™ Aortic Arch Stent Graft System Data Collection Study for Compassionate-Use Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Arch Aneurysm
- Sponsor
- Endospan Ltd.
- Enrollment
- 7
- Locations
- 4
- Primary Endpoint
- Performance Evaluation Criteria
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •There are no exclusions. Data will be collected for all implanted population as described in the inclusion section above
Outcomes
Primary Outcomes
Performance Evaluation Criteria
Time Frame: 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.
Primary Safety Evaluation Criteria
Time Frame: within 30 days post implantation
Device related mortality at 30 days post implantation based on review of medical charts by the Investigators
Secondary Outcomes
- Secondary Safety Evaluation Criteria(within 1 year post-implantation)