Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study
NCT ID: NCT00890045
Last Updated: 2024-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2004-07-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control graft
Conventional ePTFE hemodialysis graft
Conventional ePTFE hemodialysis graft
Conventional ePTFE hemodialysis graft
HeRO Vascular Access Device
HeRO Vascular Access Device
HeRO Vascular Access Device
HeRO Vascular Access Device
Interventions
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HeRO Vascular Access Device
HeRO Vascular Access Device
Conventional ePTFE hemodialysis graft
Conventional ePTFE hemodialysis graft
Eligibility Criteria
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Inclusion Criteria
2. Male or non-pregnant female.
3. Life expectancy 2 years.
4. End-stage renal disease requiring an arm vascular prosthesis for dialysis access.
5. Ability to understand and provide written informed consent.
6. Willing and able to cooperate with follow-up examinations.
7. 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.).
8. Able to follow a daily aspirin and/or other oral anticoagulation/antiplatelet regimen.
Exclusion Criteria
2. Documented history of drug abuse within six months.
3. "Planned" concomitant surgical procedure or previous major surgery within 30 days, excluding vascular access related procedures.
4. Currently being treated with another investigational device or drug.
5. Known bleeding diathesis or hypercoagulable state.
6. Peripheral white blood cell count 1500/mm3 (1.5 K/mm3) or platelet counts 50,000/mm3 (50 K/mm3).
7. Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be included.
8. 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.
9. Severe underlying co-morbidity or immediate life-threatening condition.
10. 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.
11. Subjects who are candidates for autologous fistulas.
12. Subjects with scheduled renal transplant within the next 12 months.
22 Years
99 Years
ALL
No
Sponsors
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CryoLife, Inc.
INDUSTRY
Merit Medical Systems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Glickman, MD
Role: PRINCIPAL_INVESTIGATOR
Sentara Heart Hospital, Norfolk, VA
Locations
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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
Countries
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References
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Nassar GM, Glickman MH, McLafferty RB, Croston JK, Zarge JI, Katzman HE, Peden EK, Lawson JH, Martinez JM, Thackeray L. A comparison between the HeRO graft and conventional arteriovenous grafts in hemodialysis patients. Semin Dial. 2014 May-Jun;27(3):310-8. doi: 10.1111/sdi.12173. Epub 2014 Jan 15.
Other Identifiers
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11-0004
Identifier Type: -
Identifier Source: org_study_id
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