The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients. It is hypothesized the bacteremia rate associated with the HeRO device will be lower than a historical literature control of tunneled dialysis catheters.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 21 years of age or older.
✓. Male or non-pregnant female.
✓. Life expectancy less than 1 year.
✓. ESRD on hemodialysis with poor remaining venous access sites for creation of an AV fistula or placement of a graft in the upper extremities.
✓. Implant side central venous system that surgeon believes can be accessed with interventional devices and can accommodate the 19 Fr GVAS device.
✓. Potential GVAS target brachial artery ≥ 3 mm in diameter determined by any suitable measure.
✓. Ability to understand and provide written informed consent.
✓. Willing and able to cooperate with follow-up examinations.
Exclusion criteria
✕. Documented history of drug abuse within six months prior to enrollment.
✕. "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 hypercoaguable state.
✕. Peripheral white blood cell count 1.5 K/mm3 or platelet count 50 K/mm3.
What they're measuring
1
HeRO superiority in device and implant procedure-related bacteremia compared to historical tunneled dialysis catheter literature control
✕. Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be enrolled if receiving no immunosuppressants or low dose prednisone only (\< 10 mg/day orally).
✕. Subjects with known or suspected concomitant active bacterial, fungal, viral, or parasitic infection. Subjects with Hepatitis B and/or Hepatitis C may be enrolled. Subjects who are HIV + with CD4 count of \< 200 are excluded. Subjects with bacteremia within the past six (6) weeks must have negative blood cultures one week after completing appropriate antibiotic therapy prior to enrollment.
✕. Severe underlying co-morbidity or immediate life-threatening condition.