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Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

Primary Purpose

Renal Failure Chronic Requiring Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HeRO Vascular Access Device
Conventional ePTFE hemodialysis graft
Sponsored by
Merit Medical Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure Chronic Requiring Hemodialysis focused on measuring Vascular access hemodialysis, ePTFE graft, Graft-eligible, Long-term vascular access for hemodialysis

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • St. Vincent's Medical Center
  • University of Miami/Cedars Medical Center
  • St. Joseph's Hospital
  • Southern Illinois Unversity
  • Holy Cross Hospital
  • North Memorial Medical Center
  • Duke Medical Center
  • Seton/Brackenridge Hospitals
  • Baylor Medical Center/Methodist Hospital
  • Baptist Medical Center
  • Sentara Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control graft

HeRO Vascular Access Device

Arm Description

Conventional ePTFE hemodialysis graft

HeRO Vascular Access Device

Outcomes

Primary Outcome Measures

Percentage of Patients With Primary Patency
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
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
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
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

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

Full Information

First Posted
April 27, 2009
Last Updated
June 15, 2021
Sponsor
Merit Medical Systems, Inc.
Collaborators
CryoLife, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00890045
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merit Medical Systems, Inc.
Collaborators
CryoLife, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Chronic Requiring Hemodialysis
Keywords
Vascular access hemodialysis, ePTFE graft, Graft-eligible, Long-term vascular access for hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control graft
Arm Type
Active Comparator
Arm Description
Conventional ePTFE hemodialysis graft
Arm Title
HeRO Vascular Access Device
Arm Type
Experimental
Arm Description
HeRO Vascular Access Device
Intervention Type
Device
Intervention Name(s)
HeRO Vascular Access Device
Intervention Description
HeRO Vascular Access Device
Intervention Type
Device
Intervention Name(s)
Conventional ePTFE hemodialysis graft
Intervention Description
Conventional ePTFE hemodialysis graft
Primary Outcome Measure Information:
Title
Percentage of Patients With Primary Patency
Description
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.
Time Frame
6 months, 12 months
Title
Percentage of Patients With Assisted Primary Patency
Description
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.
Time Frame
6 months, 12 months
Title
Percentage of Patients With Secondary Patency
Description
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.
Time Frame
12 months
Title
Number of Patients With Serious Device or Implant Procedure-related Adverse Events
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adequacy of Dialysis
Description
Reported as Mean Kt/V, K= dialyzer clearance of urea, t= dialysis time, V=subject total body water
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Glickman, MD
Organizational Affiliation
Sentara Heart Hospital, Norfolk, VA
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
University of Miami/Cedars Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
St. Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Southern Illinois Unversity
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Holy Cross Hospital
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
North Memorial Medical Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Duke Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Seton/Brackenridge Hospitals
City
Austin
State/Province
Texas
ZIP/Postal Code
78703
Country
United States
Facility Name
Baylor Medical Center/Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baptist Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Sentara Heart Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24428351
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.
Results Reference
result

Learn more about this trial

Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

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