N/A
N=72
Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study
Renal Failure Chronic Requiring Hemodialysis
Bottom Line
View on ClinicalTrials.gov: NCT00890045 ↗Enrolled (actual)
72
Serious AEs
33.3%
Results posted
Jun 2021
Primary outcome: Primary: Percentage of Patients With Primary Patency — 48.2; 47.0; 30.6; 34.8 percentage of participants patent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HeRO Vascular Access Device (Device); Conventional ePTFE hemodialysis graft (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Merit Medical Systems, Inc.
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Primary Patency |
48.2; 47.0; 30.6; 34.8 | — |
| PRIMARY Percentage of Patients With Assisted Primary Patency |
88.8; 86.2; 75.2; 79.8 | — |
| PRIMARY Percentage of Patients With Secondary Patency |
58.4; 76.7; 58.4; 67.6 | — |
| PRIMARY Number of Patients With Serious Device or Implant Procedure-related Adverse Events |
0; 6; 0; 1; 0; 1 | — |
| SECONDARY Adequacy of Dialysis |
1.7; 1.6 | — |
Summary
Compare the HeRO Vascular Access Device to a conventional ePTFE graft.
Eligibility Criteria
Inclusion Criteria
- 22 years of age or older.
- Male or non-pregnant female.
- Life expectancy 2 years.
- End-stage renal disease requiring an arm vascular prosthesis for dialysis access.
- Ability to understand and provide written informed consent.
- Willing and able to cooperate with follow-up examinations.
- 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.).
- Able to follow a daily aspirin and/or other oral anticoagulation/antiplatelet regimen.
Exclusion Criteria
- Potential graft target artery less than 3 mm in diameter determined by any suitable preoperative measure.
- Documented history of drug abuse within six months.
- "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 hypercoagulable state.
- Peripheral white blood cell count 1500/mm3 (1.5 K/mm3) or platelet counts 50,000/mm3 (50 K/mm3).
- Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be included.
- 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.
- 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 who are candidates for autologous fistulas.
- Subjects with scheduled renal transplant within the next 12 months.
Data sourced from ClinicalTrials.gov (NCT00890045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.