- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00889564
HeRO Vascular Access Device Bacteremia Study
August 7, 2017 updated by: Merit Medical Systems, Inc.
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 bacteremia rate associated with the HeRO device will be lower than a historical literature control of tunneled dialysis catheters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Miami, Florida, United States, 33125
- University of Miami / Cedars Medical Center
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-
Georgia
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Atlanta, Georgia, United States, 30342
- St. Joseph's Hospital
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Illinois
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Springfield, Illinois, United States, 62702
- Southern Illinois University
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Minnesota
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Robbinsdale, Minnesota, United States, 55422
- North Memorial Medical Center
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South Carolina
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Bamberg, South Carolina, United States, 29003
- Bamberg County Hospital
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Texas
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San Antonio, Texas, United States, 78205
- Baptist Medical Center
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Virginia
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Norfolk, Virginia, United States, 23507
- Sentara Heart Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HeRO superiority in device and implant procedure-related bacteremia compared to historical tunneled dialysis catheter literature control
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of serious device or implant procedure-related serious adverse events and loss of secondary patency
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Ross, MD, Bamberg County Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (ACTUAL)
March 1, 2007
Study Completion (ACTUAL)
March 1, 2007
Study Registration Dates
First Submitted
April 27, 2009
First Submitted That Met QC Criteria
April 28, 2009
First Posted (ESTIMATE)
April 29, 2009
Study Record Updates
Last Update Posted (ACTUAL)
August 8, 2017
Last Update Submitted That Met QC Criteria
August 7, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-0050
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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