CompletedNot Applicable

Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

United States72 participantsStarted 2004-07

Plain-language summary

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

Who can participate

Age range

22 Years – 99 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

. 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.

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

Percentage of Patients With Primary Patency

Timeframe: 6 months, 12 months

Percentage of Patients With Assisted Primary Patency

Timeframe: 6 months, 12 months

Percentage of Patients With Secondary Patency

Timeframe: 12 months

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

Timeframe: 12 months

Trial details

NCT IDNCT00890045

SponsorMerit Medical Systems, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-03

Results submitted2021-05-05

View on ClinicalTrials.gov More Renal Failure Chronic Requiring Hemodialysis trials

Who can participate

Age range

22 Years – 99 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

. 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.

What they're measuring

Percentage of Patients With Primary Patency

Timeframe: 6 months, 12 months

Percentage of Patients With Assisted Primary Patency

Timeframe: 6 months, 12 months

Percentage of Patients With Secondary Patency

Timeframe: 12 months

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

Timeframe: 12 months