The NEXUS™ Compassionate Use Data Collection Study

Endospan

Status: Completed

Conditions: Aortic Arch Aneurysm

Treatments: Other: Retrospective data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT03420066

CIP008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

7 participants in 1 patient group

Retrospective data collection

Description:

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)

Treatment:

Other: Retrospective data collection