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OpenTrials
Completed

NCT Number: NCT03420066

The NEXUS™ Compassionate Use Data Collection Study

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.

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Key information

Conditions

Aortic Arch Aneurysm Aneurysm Aneurysm, Aortic Arch Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale San Filippo Neri, Rome, Lazio, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrospective data collection

Other

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.

Primary outcomes

  1. Primary Safety Evaluation Criteria

    Time frame: within 30 days post implantation

    Device related mortality at 30 days post implantation based on review of medical charts by the Investigators

  2. Performance Evaluation Criteria

    Time frame: 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.

Secondary outcomes

  1. Secondary Safety Evaluation Criteria

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Endospan Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2023
First posted
Feb 5, 2018
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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