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

End Stage Renal Failure on Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02164175
• Other study ID #: HRG1301.000-M
• Status: Withdrawn
• Start date: December 2013
• Est. completion date: December 2023

Study information

• Verified date: May 2021
• Source: Merit Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Baylor Research Institute	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Sentara Medical Group Sentara Vascular Specialists	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.	CryoLife, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalization rate	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
Other	Patency rate	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
Other	Intervention rate	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
Other	Adverse events	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
Other	Blood pressure	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
Primary	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	Adequacy of dialysis (Kt/V)	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
Secondary	Infection rate	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

External Links

•   HeRO Graft website