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Completed

NCT Number: NCT00890045

Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

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

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Key information

Conditions

Renal Failure Chronic Requiring Hemodialysis

Age range

22 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincent's Medical Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 22 years of age or older.
  • Male or non-pregnant female.
  • Life expectancy 2 years.
  • End-stage renal disease requiring an arm vascular prosthesis for dialysis access.
  • Ability to understand and provide written informed consent.
  • Willing and able to cooperate with follow-up examinations.
  • 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.).
  • Able to follow a daily aspirin and/or other oral anticoagulation/antiplatelet regimen.

Exclusion criteria

  • Potential graft target artery less than 3 mm in diameter determined by any suitable preoperative measure.
  • Documented history of drug abuse within six months.
  • "Planned" concomitant surgical procedure or previous major surgery within 30 days, excluding vascular access related procedures.
  • Currently being treated with another investigational device or drug.
  • Known bleeding diathesis or hypercoagulable state.
  • Peripheral white blood cell count 1500/mm3 (1.5 K/mm3) or platelet counts 50,000/mm3 (50 K/mm3).
  • Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be included.
  • 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.
  • Severe underlying co-morbidity or immediate life-threatening condition.
  • 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.
  • Subjects who are candidates for autologous fistulas.
  • Subjects with scheduled renal transplant within the next 12 months.

Treatment and study plan

HeRO Vascular Access Device

Device

HeRO Vascular Access Device

Conventional ePTFE hemodialysis graft

Device

Conventional ePTFE hemodialysis graft

Primary outcomes

  1. Percentage of Patients With Primary Patency

    Time frame: 6 months, 12 months

    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.

  2. Percentage of Patients With Assisted Primary Patency

    Time frame: 6 months, 12 months

    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.

  3. Percentage of Patients With Secondary Patency

    Time frame: 12 months

    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.

  4. Number of Patients With Serious Device or Implant Procedure-related Adverse Events

    Time frame: 12 months

    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.

Secondary outcomes

  1. Adequacy of Dialysis

    Time frame: 12 months

    Reported as Mean Kt/V, K= dialyzer clearance of urea, t= dialysis time, V=subject total body water

Sponsors and collaborators

Lead sponsor

Merit Medical Systems, Inc.

Industry

Collaborators

  • CryoLife, Inc.

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Apr 29, 2009
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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