The NEXUS™ Compassionate Use Data Collection Study

Aortic Arch Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420066
• Other study ID #: CIP008
• Status: Completed
• Start date: February 19, 2018
• Est. completion date: November 28, 2023

Study information

• Verified date: January 2024
• Source: Endospan Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 28, 2023
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Arch Aneurysm

Intervention

Other:
• Retrospective data collection
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.

Locations

Country	Name	City	State
Italy	Ospedale San Filippo Neri	Roma	Lazio
New Zealand	ADHB Charitable Trust	Auckland
Switzerland	Klinik Hirslanden	Zürich
Switzerland	Zurich University Hospital	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Endospan Ltd.

Countries where clinical trial is conducted

Italy,  New Zealand,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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