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

NCT02164175 | Withdrawn

• 1 other identifier: HRG1301.000-M
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

End Stage Renal Failure on Dialysis

Keywords

HeRO Graft

Outcome Measures

Primary Outcomes (1)

• Mortality

  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 Outcomes (2)

• Adequacy of dialysis (Kt/V)

  Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years

• Infection rate

  Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years

Other Outcomes (5)

• Hospitalization rate

  Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years

• Patency rate

  Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years

• Intervention rate

  Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years

Study Arms (1)

HeRO Graft

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

Device: HeRO Graft implant for dialysis access

Interventions

HeRO Graft implant for dialysis access DEVICE

End Stage Renal Disease patients who receive HeRO Graft implant for dialysis access

HeRO Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients eligible for HeRO Graft for dialysis access

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead
• CryoLife, Inc.: collaborator

Study Sites (3)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Baylor Research Institute

Dallas, Texas, 75246, United States

Location

Sentara Medical Group Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

Related Publications (3)

• Gage SM, Katzman HE, Ross JR, Hohmann SE, Sharpe CA, Butterly DW, Lawson JH. Multi-center experience of 164 consecutive Hemodialysis Reliable Outflow [HeRO] graft implants for hemodialysis treatment. Eur J Vasc Endovasc Surg. 2012 Jul;44(1):93-9. doi: 10.1016/j.ejvs.2012.04.011. Epub 2012 May 12.

  PMID: 22580402 BACKGROUND

• Katzman HE, McLafferty RB, Ross JR, Glickman MH, Peden EK, Lawson JH. Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. J Vasc Surg. 2009 Sep;50(3):600-7, 607.e1. doi: 10.1016/j.jvs.2009.04.014. Epub 2009 Jul 22.

  PMID: 19628360 BACKGROUND

• Nassar GM, Glickman MH, McLafferty RB, Croston JK, Zarge JI, Katzman HE, Peden EK, Lawson JH, Martinez JM, Thackeray L. A comparison between the HeRO graft and conventional arteriovenous grafts in hemodialysis patients. Semin Dial. 2014 May-Jun;27(3):310-8. doi: 10.1111/sdi.12173. Epub 2014 Jan 15.

  PMID: 24428351 BACKGROUND

Related Links

• HeRO Graft website

Study Officials

• Jeffrey Lawson, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 16, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2023
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

US (3)