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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03420066
Other study ID # CIP008
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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