Clinical trial NCT00889564: HeRO Vascular Access Device Bacteremia Study
Official title: HeRO Vascular Access Device Bacteremia Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Keywords: Vascular access for hemodialysis
Catheter dependent patients
Access challenged patients
Bacteremia
HeRO Vascular Access Device
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Integra Clinical Trial Solutions - statistical analysis
name: Ross, John, M.D.
First posted: 2009-04-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 bacteremia rate associated with the HeRO device will be lower than a historical literature control of tunneled dialysis catheters.


Eligibility criteria: Inclusion Criteria:

1. 21 years of age or older.
2. Male or non-pregnant female.
3. Life expectancy less than 1 year.
4. ESRD on hemodialysis with poor remaining venous access sites for creation of an AV fistula or placement of a graft in the upper extremities.
5. Implant side central venous system that surgeon believes can be accessed with interventional devices and can accommodate the 19 Fr GVAS device.
6. Potential GVAS target brachial artery ≥ 3 mm in diameter determined by any suitable measure.
7. Ability to understand and provide written informed consent.
8. Willing and able to cooperate with follow-up examinations.

Exclusion Criteria:

1. Documented history of drug abuse within six months prior to enrollment.
2. "Planned" concomitant surgical procedure or previous major surgery within 30 days, excluding vascular access related procedures.
3. Currently being treated with another investigational device or drug.
4. Known bleeding diathesis or hypercoaguable state.
5. Peripheral white blood cell count 1.5 K/mm3 or platelet count 50 K/mm3.
6. 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).
7. 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.
8. Severe underlying co-morbidity or immediate life-threatening condition.
9. 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.
10. Subjects with significant arterial occlusive disease which would preclude safe placement of an upper extremity hemodialysis access.
11. 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.).
12. Subjects with scheduled kidney transplant within the next 12 months.
13. Subjects with history of superior vena cava syndrome are excluded unless it was induced by previous access (these subjects can be enrolled).
14. 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.
15. Subjects with history of uncorrected hypotension with systolic blood pressures routinely \< 100 mg Hg.
16. Subjects who currently have a pacemaker or ICD in their central venous system on the same side where the GVAS device would be implanted.

Primary outcomes:
measure: HeRO superiority in device and implant procedure-related bacteremia compared to historical tunneled dialysis catheter literature control
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of serious device or implant procedure-related serious adverse events and loss of secondary patency
timeFrame: 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami / Cedars Medical Center
state: Florida
city: Atlanta
country: United States
facility: St. Joseph's Hospital
state: Georgia
city: Springfield
country: United States
facility: Southern Illinois University
state: Illinois
city: Robbinsdale
country: United States
facility: North Memorial Medical Center
state: Minnesota
city: Bamberg
country: United States
facility: Bamberg County Hospital
state: South Carolina
city: San Antonio
country: United States
facility: Baptist Medical Center
state: Texas
city: Norfolk
country: United States
facility: Sentara Heart Hospital
state: Virginia
Study officials:
affiliation: Bamberg County Hospital
name: John Ross, MD
role: PRINCIPAL_INVESTIGATOR
References: