Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

Not Applicable

Completed

• Conditions: Renal Failure Chronic Requiring Hemodialysis
• Interventions: Device: HeRO Vascular Access Device; Device: Conventional ePTFE hemodialysis graft

• Registration Number: NCT00890045
• Lead Sponsor: Merit Medical Systems, Inc.

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.

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Results First Submitted: 2021-05-05
• Results First Submitted QC: 2021-06-08
• Results First Posted: 2021-06-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HeRO Vascular Access Device	HeRO Vascular Access Device	HeRO Vascular Access Device
Control graft	Conventional ePTFE hemodialysis graft	Conventional ePTFE hemodialysis graft

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Primary Patency	6 months, 12 months	Primary patency was defined as the interval of time from access placement until any intervention designed to maintain or reestablish patency, access thrombosis, or the time of measurement of patency.
Percentage of Patients With Assisted Primary Patency	6 months, 12 months	Assisted primary patency was defined as the interval of time from access placement until access thrombosis or the time of measurement of patency, including intervening manipulations (i.e., surgical or endovascular interventions) designed to maintain the functionality of a patent access.
Percentage of Patients With Secondary Patency	12 months	Secondary patency was defined as the interval of time from access placement until access abandonment, thrombosis, or the time of patency measurements including intervening surgical or endovascular interventions designed to reestablish functionality in a thrombosed access.
Number of Patients With Serious Device or Implant Procedure-related Adverse Events	12 months	Serious adverse events were defined as events that required hospitalization ≥24 hours, prolonged an existing hospitalization, resulted in persistent or significant disability or incapacity, were considered life-threatening, or resulted in death.

Secondary Outcome Measures

Name	Time	Method
Adequacy of Dialysis	12 months	Reported as Mean Kt/V, K= dialyzer clearance of urea, t= dialysis time, V=subject total body water

Trial Locations

Locations (11)

St. Vincent's Medical Center; 🇺🇸 Los Angeles, California, United States

University of Miami/Cedars Medical Center; 🇺🇸 Miami, Florida, United States

Southern Illinois Unversity; 🇺🇸 Springfield, Illinois, United States

St. Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States

North Memorial Medical Center; 🇺🇸 Robbinsdale, Minnesota, United States

Holy Cross Hospital; 🇺🇸 Rockville, Maryland, United States

Duke Medical Center; 🇺🇸 Durham, North Carolina, United States

Seton/Brackenridge Hospitals; 🇺🇸 Austin, Texas, United States

Baylor Medical Center/Methodist Hospital; 🇺🇸 Houston, Texas, United States

Baptist Medical Center; 🇺🇸 San Antonio, Texas, United States

Sentara Heart Hospital; 🇺🇸 Norfolk, Virginia, United States