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

Withdrawn

• Conditions: End Stage Renal Failure on Dialysis
• Interventions: Device: HeRO Graft implant for dialysis access

• Registration Number: NCT02164175
• Lead Sponsor: Merit Medical Systems, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-05-29
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-16
• Primary Completion: 2018-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HeRO Graft	HeRO Graft implant for dialysis access	End stage renal disease patients who receive HeRO Graft implant for dialysis access

Primary Outcome Measures

Name	Time	Method
Mortality	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.

Secondary Outcome Measures

Name	Time	Method
Adequacy of dialysis (Kt/V)	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.
Infection rate	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.

Trial Locations

Locations (3)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Baylor Research Institute; 🇺🇸 Dallas, Texas, United States

Sentara Medical Group Sentara Vascular Specialists; 🇺🇸 Norfolk, Virginia, United States