The NEXUS™ Compassionate Use Data Collection Study

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Arch Aneurysm
• Intervention / Treatment: Other: Retrospective data collection

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 Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00135
      • Ospedale San Filippo Neri
• New Zealand
  • Auckland, New Zealand
    • ADHB Charitable Trust
• Switzerland
  • Zürich, Switzerland, CH-8032
    • Klinik Hirslanden
  • Zürich, Switzerland, CH-8091
    • Zurich University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population will include all patients that were implanted with the Nexus device as part of the compassionate use.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Endospan Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2018
• Primary Completion (Actual): September 14, 2018
• Study Completion (Actual): November 28, 2023

Study Registration Dates

• First Submitted: January 28, 2018
• First Submitted That Met QC Criteria: January 28, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aneurysm; Aneurysm, Aortic Arch
• Other Study ID Numbers: CIP008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No