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Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

NCT05846581 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2025-07-09

No results posted yet for this study

Summary

The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are:

* Safety: Freedom from device-related infection adverse events at 24 months from device implant
* Performance: Secondary patency at 24 months from device implant.

Participants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the device.

Conditions

  • Chronic Kidney Diseases
  • End Stage Renal Disease on Dialysis

Interventions

DEVICE

GORE® ACUSEAL Vascular Graft

The device placement will be performed according to each participating site's standard practice. No specific procedures are required by the protocol. At the time of the GORE® ACUSEAL Vascular Grafts implantation, procedural and adverse event information will be collected.

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Matteo Tozzi · University of Insubria (Italy)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2027-10-27
Completion
2027-10-27
FDA Device
Yes

Countries

  • Germany
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05846581 on ClinicalTrials.gov