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PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis

NCT06422871 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-08-05

No results posted yet for this study

Summary

The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices. This study includes adults that are being treated with one of these devices as part of their regular medical care for maintaining long-term dialysis access when all other dialysis access options have failed. If participants in the study are not seen for a standard of care clinic visit during the 4 visit timepoints over 2 years, the participant will be followed by phone to check their current health and dialysis status.

Conditions

Interventions

DEVICE

HeRO® Graft System or Super HeRO® System

Treatment attempted with the HeRO® or Super HeRO® device.

Sponsors & Collaborators

  • Merit Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen Hohmann, MD · Baylor Scott and White Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2027-06-28
Completion
2028-12-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06422871 on ClinicalTrials.gov