Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis

May 5, 2021 updated by: Merit Medical Systems, Inc.
Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Data collection including medical history, operative procedure data, and follow-up data every six months while using the HeRO Graft for dialysis, including:

  • Post-operative complications for HeRO Graft implantation
  • Length of time between insertion and use of HeRO Graft
  • Incidence of thrombosis
  • Hospitalizations
  • Incidence of infections and other adverse event occurrence
  • Mortality
  • Hemoglobin
  • Kt/V
  • pre-dialysis blood pressure
  • post-dialysis blood pressure
  • blood flow rate and
  • dialysis flow rate

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Research Institute
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Medical Group Sentara Vascular Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients eligible for HeRO Graft for dialysis access

Description

Inclusion Criteria:

  • All patients eligible for HeRO Graft for dialysis access
  • Age greater than 18 years old
  • Able to give informed consent

Exclusion Criteria:

  • Subjects with any kind of disorder that compromises the ability of the subject to give informed consent and/or to comply with the study procedures;
  • Any medical condition that in the opinion of the investigator may pose a safety risk to a subject in the study or which may interfere with study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HeRO Graft
End stage renal disease patients who receive HeRO Graft implant for dialysis access
Device: HeRO Graft implant for dialysis access
End Stage Renal Disease patients who receive HeRO Graft implant for dialysis access

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
To evaluate if the death rate of participants using the HeRO Graft is less than the death rate of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequacy of dialysis (Kt/V)
Time Frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
To evaluate if the adequacy of dialysis of participants using the HeRO Graft is better than the adequacy of dialysis of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
Infection rate
Time Frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
To evaluate if the infection rate of participants using the HeRO Graft is less than the infection rate of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization rate
Time Frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
To evaluate if the hospitalization rate of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
Patency rate
Time Frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
To evaluate if the patency rate of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
Intervention rate
Time Frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
To evaluate if the intervention rate of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
Adverse events
Time Frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
To evaluate if the number of adverse events of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
Blood pressure
Time Frame: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
To evaluate if the blood pressure of participants using the HeRO Graft is less than that of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merit Medical Systems, Inc.

Collaborators

CryoLife, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2013

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRG1301.000-M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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