Status:
COMPLETED
HeRO Vascular Access Device Bacteremia Study
Lead Sponsor:
Merit Medical Systems, Inc.
Collaborating Sponsors:
Integra Clinical Trial Solutions - statistical analysis
Ross, John, M.D.
Conditions:
Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients. It is hypothesized the ba...
Eligibility Criteria
Inclusion
- 21 years of age or older.
- Male or non-pregnant female.
- Life expectancy less than 1 year.
- ESRD on hemodialysis with poor remaining venous access sites for creation of an AV fistula or placement of a graft in the upper extremities.
- Implant side central venous system that surgeon believes can be accessed with interventional devices and can accommodate the 19 Fr GVAS device.
- Potential GVAS target brachial artery ≥ 3 mm in diameter determined by any suitable measure.
- Ability to understand and provide written informed consent.
- Willing and able to cooperate with follow-up examinations.
Exclusion
- Documented history of drug abuse within six months prior to enrollment.
- "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 hypercoaguable state.
- Peripheral white blood cell count 1.5 K/mm3 or platelet count 50 K/mm3.
- Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be enrolled if receiving no immunosuppressants or low dose prednisone only (\< 10 mg/day orally).
- Subjects with known or suspected concomitant active bacterial, fungal, viral, or parasitic infection. Subjects with Hepatitis B and/or Hepatitis C may be enrolled. Subjects who are HIV + with CD4 count of \< 200 are excluded. Subjects with bacteremia within the past six (6) weeks must have negative blood cultures one week after completing appropriate antibiotic therapy prior to enrollment.
- 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 with significant arterial occlusive disease which would preclude safe placement of an upper extremity hemodialysis access.
- Subjects with history or findings on physical examination suggesting significant arterial insufficiency that could affect patient safety and/or device performance in the extremity planned for use with GVAS (i.e., steal syndrome, hand ischemia, peripheral arterial vascular disease, etc.).
- Subjects with scheduled kidney transplant within the next 12 months.
- Subjects with history of superior vena cava syndrome are excluded unless it was induced by previous access (these subjects can be enrolled).
- Subjects with history of decreased cardiac output with ejection fraction \< 20% and/or NYHA class III or IV. NYHA definitions: Class III - Subjects with marked limitation of activity; they are comfortable only at rest; Class IV - Subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest.
- Subjects with history of uncorrected hypotension with systolic blood pressures routinely \< 100 mg Hg.
- Subjects who currently have a pacemaker or ICD in their central venous system on the same side where the GVAS device would be implanted.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00889564
Start Date
March 1 2006
End Date
March 1 2007
Last Update
August 8 2017
Active Locations (7)
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1
University of Miami / Cedars Medical Center
Miami, Florida, United States, 33125
2
St. Joseph's Hospital
Atlanta, Georgia, United States, 30342
3
Southern Illinois University
Springfield, Illinois, United States, 62702
4
North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422