Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

Completed · Not applicable

Conditions studied: Renal Failure Chronic Requiring Hemodialysis

In brief

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

Key facts

Study ID

NCT00890045

Run by

Merit Medical Systems, Inc.

People needed

72

Starts

2004-07-01

Expected to finish

2008-03-01

Last updated by the study team

2024-01-29

Who can join

Age: 22 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St. Vincent's Medical Center — Los Angeles, California, United States
• University of Miami/Cedars Medical Center — Miami, Florida, United States
• St. Joseph's Hospital — Atlanta, Georgia, United States
• Southern Illinois Unversity — Springfield, Illinois, United States
• Holy Cross Hospital — Rockville, Maryland, United States
• North Memorial Medical Center — Robbinsdale, Minnesota, United States
• Duke Medical Center — Durham, North Carolina, United States
• Seton/Brackenridge Hospitals — Austin, Texas, United States
• Baylor Medical Center/Methodist Hospital — Houston, Texas, United States
• Baptist Medical Center — San Antonio, Texas, United States
• Sentara Heart Hospital — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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