Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

Merit Medical Systems

Status: Completed

Conditions: Renal Failure Chronic Requiring Hemodialysis

Treatments: Device: Conventional ePTFE hemodialysis graft; Device: HeRO Vascular Access Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00890045

11-0004

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 22 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Control graft

Active Comparator group

Description:

Conventional ePTFE hemodialysis graft

Treatment:

Device: Conventional ePTFE hemodialysis graft

HeRO Vascular Access Device

Experimental group

Description:

HeRO Vascular Access Device

Treatment:

Device: HeRO Vascular Access Device