The NEXUS™ Compassionate Use Data Collection Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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NEXUS™ Aortic Arch Stent Graft System Data Collection Study for Compassionate-Use Procedures

Conditions
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Aortic Arch Aneurysm

Intervention / Treatment
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* Other: Retrospective data collection


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective data collection<br>Group includes subjects that were implanted with the Nexus device as part of compassionate use procedure before joining the CIP008 study. Only intervention foreseen by CIP008 study is retrospective collection of data previously recorded as standard of care in medical charts (refer to Intervention/treatment section) | Other: Retrospective data collection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Evaluation Criteria | Device related mortality at 30 days post implantation based on review of medical charts by the Investigators | 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. | within 30 days post implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 1 year post-implantation |