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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HeRO superiority in device and implant procedure-related bacteremia compared to historical tunneled dialysis catheter literature control
. 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.
. 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.