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.

Age range22 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

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

NCT IDNCT00890045

SponsorMerit Medical Systems, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-03

Results submitted2021-05-05

Who can participate

Age range22 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

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