Aortic Arch Aneurysm
Conditions
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.
Interventions
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.
Sponsors
Endospan Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy, New Zealand, Switzerland
Outcome results
None listed