Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

Study Overview
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Brief Summary
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Compare the HeRO Vascular Access Device to a conventional ePTFE graft.

Detailed Description
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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.

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

Conditions
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Renal Failure Chronic Requiring Hemodialysis

Intervention / Treatment
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* Device: HeRO Vascular Access Device
* Device: Conventional ePTFE hemodialysis graft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control graft<br>Conventional ePTFE hemodialysis graft | Device: Conventional ePTFE hemodialysis graft<br>* Conventional ePTFE hemodialysis graft<br>|
| Experimental: HeRO Vascular Access Device<br>HeRO Vascular Access Device | Device: HeRO Vascular Access Device<br>* HeRO Vascular Access Device<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular access hemodialysis, ePTFE graft, Graft-eligible, Long-term vascular access for hemodialysis