Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

This study has been completed.
Sponsor:
Collaborator:
CryoLife, Inc.
Information provided by (Responsible Party):
Hemosphere, Inc.
ClinicalTrials.gov Identifier:
NCT00890045
First received: April 27, 2009
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Renal Failure Chronic Requiring Hemodialysis
Device: HeRO Vascular Access Device
Device: Conventional ePTFE hemodialysis graft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison Between the HeRO® Graft and Conventional Arteriovenous Grafts in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Hemosphere, Inc.:

Primary Outcome Measures:
  • Loss of HeRO secondary patency compared to control [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Loss of HeRO primary patency compared to control [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • HeRO serious device or implant procedure-related adverse events compared to control [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: July 2004
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control graft
Conventional ePTFE hemodialysis graft
Device: Conventional ePTFE hemodialysis graft
Conventional ePTFE hemodialysis graft
Experimental: HeRO Vascular Access Device
HeRO Vascular Access Device
Device: HeRO Vascular Access Device
HeRO Vascular Access Device
Other Name: HeRO Vascular Access Device

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 21 years of age or older.
  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:

  1. Potential graft target artery less than 3 mm in diameter determined by any suitable preoperative measure.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890045

Locations
United States, California
St. Vincent's Medical Center
Los Angeles, California, United States, 90057
United States, Florida
University of Miami/Cedars Medical Center
Miami, Florida, United States, 33125
United States, Georgia
St. Joseph's Hospital
Atlanta, Georgia, United States, 30342
United States, Illinois
Southern Illinois Unversity
Springfield, Illinois, United States, 62702
United States, Maryland
Holy Cross Hospital
Rockville, Maryland, United States, 20852
United States, Minnesota
North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422
United States, North Carolina
Duke Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
Seton/Brackenridge Hospitals
Austin, Texas, United States, 78703
Baylor Medical Center/Methodist Hospital
Houston, Texas, United States, 77030
Baptist Medical Center
San Antonio, Texas, United States, 78205
United States, Virginia
Sentara Heart Hospital
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Hemosphere, Inc.
CryoLife, Inc.
Investigators
Principal Investigator: Marc Glickman, MD Sentara Heart Hospital, Norfolk, VA
  More Information

Publications:
Responsible Party: Hemosphere, Inc.
ClinicalTrials.gov Identifier: NCT00890045     History of Changes
Other Study ID Numbers: 11-0004
Study First Received: April 27, 2009
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Hemosphere, Inc.:
Vascular access hemodialysis
ePTFE graft
Graft-eligible
Long-term vascular access for hemodialysis

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014