Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

A Comparison Between the HeRO® Graft and Conventional Arteriovenous Grafts in Hemodialysis Patients

Compare the HeRO Vascular Access Device to a conventional ePTFE graft.

Study Overview

• Status: Completed
• Conditions: Renal Failure Chronic Requiring Hemodialysis
• Intervention / Treatment: Device: Conventional ePTFE hemodialysis graft; Device: HeRO Vascular Access Device

Detailed Description

The purpose of this study is to compare the HeRO Vascular Access Device to a conventional ePTFE graft. It is hypothesized that HeRO patency will be comparable to the conventional ePTFE graft control.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90057
      • St. Vincent's Medical Center
  • Florida
    • Miami, Florida, United States, 33125
      • University of Miami/Cedars Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • St. Joseph's Hospital
  • Illinois
    • Springfield, Illinois, United States, 62702
      • Southern Illinois Unversity
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Holy Cross Hospital
  • Minnesota
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Medical Center
  • Texas
    • Austin, Texas, United States, 78703
      • Seton/Brackenridge Hospitals
    • Houston, Texas, United States, 77030
      • Baylor Medical Center/Methodist Hospital
    • San Antonio, Texas, United States, 78205
      • Baptist Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 22 years of age or older.
2. Male or non-pregnant female.
3. Life expectancy 2 years.
4. End-stage renal disease requiring an arm vascular prosthesis for dialysis access.
5. Ability to understand and provide written informed consent.
6. Willing and able to cooperate with follow-up examinations.
7. Subject's upper arm can be used for implant (Note: The GVAS device must be implanted in the upper arm only, but the Control group graft can be implanted in the upper or lower arm location.).
8. Able to follow a daily aspirin and/or other oral anticoagulation/antiplatelet regimen.

Exclusion Criteria:

1. Potential graft target artery less than 3 mm in diameter determined by any suitable preoperative measure.
2. Documented history of drug abuse within six months.
3. "Planned" concomitant surgical procedure or previous major surgery within 30 days, excluding vascular access related procedures.
4. Currently being treated with another investigational device or drug.
5. Known bleeding diathesis or hypercoagulable state.
6. Peripheral white blood cell count 1500/mm3 (1.5 K/mm3) or platelet counts 50,000/mm3 (50 K/mm3).
7. Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be included.
8. Subjects with known or suspected concomitant bacterial, fungal, viral, or parasitic infection. Subjects with Hepatitis B may be included. Subjects who are HIV + with CD4 count of <200 are excluded.
9. Severe underlying co-morbidity or immediate life-threatening condition.
10. Subjects with any condition which, in the opinion of the investigator, could preclude evaluation of response or completion of follow-up or affect subject safety.
11. Subjects who are candidates for autologous fistulas.
12. Subjects with scheduled renal transplant within the next 12 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control graft; Conventional ePTFE hemodialysis graft	Device: Conventional ePTFE hemodialysis graft; Conventional ePTFE hemodialysis graft
Experimental: HeRO Vascular Access Device	Device: HeRO Vascular Access Device; HeRO Vascular Access Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Primary Patency	Primary patency was defined as the interval of time from access placement until any intervention designed to maintain or reestablish patency, access thrombosis, or the time of measurement of patency.	6 months, 12 months
Percentage of Patients With Assisted Primary Patency	Assisted primary patency was defined as the interval of time from access placement until access thrombosis or the time of measurement of patency, including intervening manipulations (i.e., surgical or endovascular interventions) designed to maintain the functionality of a patent access.	6 months, 12 months
Percentage of Patients With Secondary Patency	Secondary patency was defined as the interval of time from access placement until access abandonment, thrombosis, or the time of patency measurements including intervening surgical or endovascular interventions designed to reestablish functionality in a thrombosed access.	12 months
Number of Patients With Serious Device or Implant Procedure-related Adverse Events	Serious adverse events were defined as events that required hospitalization ≥24 hours, prolonged an existing hospitalization, resulted in persistent or significant disability or incapacity, were considered life-threatening, or resulted in death.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy of Dialysis	Reported as Mean Kt/V, K= dialyzer clearance of urea, t= dialysis time, V=subject total body water	12 months

Collaborators and Investigators

• Sponsor: Merit Medical Systems, Inc.
• Collaborators: CryoLife, Inc.
• Investigators: Principal Investigator: Marc Glickman, MD, Sentara Heart Hospital, Norfolk, VA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (Estimated): April 29, 2009

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Vascular access hemodialysis; ePTFE graft; Graft-eligible; Long-term vascular access for hemodialysis
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 11-0004