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Status:

COMPLETED

Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

Lead Sponsor:

Merit Medical Systems, Inc.

Collaborating Sponsors:

CryoLife, Inc.

Conditions:

Renal Failure Chronic Requiring Hemodialysis

Eligibility:

All Genders

22-99 years

Phase:

NA

Brief Summary

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

Detailed Description

The purpose of this study is to compare the HeRO Vascular Access Device to a conventional ePTFE graft. It is hypothesized that HeRO patency will be comparable to the conventional ePTFE graft control.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2008

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT00890045

Start Date

July 1 2004

End Date

March 1 2008

Last Update

January 29 2024

Active Locations (11)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (11 locations)

1

St. Vincent's Medical Center

Los Angeles, California, United States, 90057

2

University of Miami/Cedars Medical Center

Miami, Florida, United States, 33125

3

St. Joseph's Hospital

Atlanta, Georgia, United States, 30342

4

Southern Illinois Unversity

Springfield, Illinois, United States, 62702