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

Study acronym: PReSeRVE-HD
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study sites: 3 to 7v6
  2. Study sites: 1 to 3
    • Primary completion date: Apr 30, 2027 to Jun 28, 2027
    • Study completion date: Oct 30, 2028 to Dec 28, 2028
    • Start date changed from estimate of May 30, 2025 to Jul 28, 2025
    v5
  3. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date: Feb 15, 2025 to May 30, 2025
    • Study sites: 0 to 1
    • Primary completion date: Jan 15, 2027 to Apr 30, 2027
    • Study completion date: Jul 15, 2028 to Oct 30, 2028
  4. Enrollment target: 175 to 100
    • Primary endpoints: 2 to 1
    • Secondary endpoints: 3 to 4
    v3
  5. Study title expanded, about 1 wordv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06422871
Lead Sponsor Merit Medical Systems, Inc.
Conditions
(from sponsor)		 End Stage Renal Disease, Hemodialysis Access Failure
Related terms Kidney Failure, Chronic
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov