Clinical trial NCT00890045: Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study
Official title: A Comparison Between the HeRO® Graft and Conventional Arteriovenous Grafts in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure Chronic Requiring Hemodialysis
Keywords: Vascular access hemodialysis
ePTFE graft
Graft-eligible
Long-term vascular access for hemodialysis
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: CryoLife, Inc.
First posted: 2009-04-29
Enrollment: 72
Sex: ALL
Minimum age (years): 22
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 criteria: Inclusion Criteria:

1. 22 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.

Primary outcomes:
measure: Percentage of Patients With Primary Patency
timeFrame: 6 months, 12 months
measure: Percentage of Patients With Assisted Primary Patency
timeFrame: 6 months, 12 months
measure: Percentage of Patients With Secondary Patency
timeFrame: 12 months
measure: Number of Patients With Serious Device or Implant Procedure-related Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Adequacy of Dialysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: St. Vincent's Medical Center
state: California
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 Unversity
state: Illinois
city: Rockville
country: United States
facility: Holy Cross Hospital
state: Maryland
city: Robbinsdale
country: United States
facility: North Memorial Medical Center
state: Minnesota
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Austin
country: United States
facility: Seton/Brackenridge Hospitals
state: Texas
city: Houston
country: United States
facility: Baylor Medical Center/Methodist Hospital
state: Texas
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: Sentara Heart Hospital, Norfolk, VA
name: Marc Glickman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.