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)
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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