The NEXUS™ Compassionate Use Data Collection Study

NCT03420066 | Completed

• 1 other identifier: CIP008
• Study Type: observational
• Target: 7
• Locations: 3 countries
• Sites: 4

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.

Conditions

Aortic Arch Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Secondary Safety Evaluation Criteria

  within 1 year post-implantation

Study Arms (1)

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

Interventions

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.

Retrospective data collection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Endospan Ltd.: lead

Study Sites (4)

Ospedale San Filippo Neri

Rome, Lazio, 00135, Italy

Location

ADHB Charitable Trust

Auckland, New Zealand

Location

Klinik Hirslanden

Zurich, CH-8032, Switzerland

Location

Zurich University Hospital

Zurich, CH-8091, Switzerland

Location

MeSH Terms

Conditions

Aneurysm, Aortic Arch

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2018
• First Posted: February 5, 2018
• Study Start: February 19, 2018
• Primary Completion: September 14, 2018
• Study Completion: November 28, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); CH (2); IT (1)