The NEXUS™ Compassionate Use Data Collection Study

Completed

• Conditions: Aortic Arch Aneurysm
• Interventions: Other: Retrospective data collection

• Registration Number: NCT03420066
• Lead Sponsor: Endospan Ltd.

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.

Study Timeline

• Study First Submitted: 2018-01-28
• Study First Submitted QC: 2018-01-28
• Study First Posted: 2018-02-05
• Study Start: 2018-02-19
• Primary Completion: 2018-09-14
• Study Completion: 2023-11-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective data collection	Retrospective data collection	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)

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Klinik Hirslanden; 🇨🇭 Zürich, Switzerland

Zurich University Hospital; 🇨🇭 Zürich, Switzerland

Ospedale San Filippo Neri; 🇮🇹 Roma, Lazio, Italy

ADHB Charitable Trust; 🇳🇿 Auckland, New Zealand