NCT00890045

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
12.1 years until next milestone

Results Posted

Study results publicly available

June 9, 2021

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

3.7 years

First QC Date

April 27, 2009

Results QC Date

May 5, 2021

Last Update Submit

January 25, 2024

Conditions

Renal Failure Chronic Requiring Hemodialysis

Keywords

Vascular access hemodialysisePTFE graftGraft-eligibleLong-term vascular access for hemodialysis

Outcome Measures

Primary Outcomes (4)

  • 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.

    6 months, 12 months

  • 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.

    6 months, 12 months

  • 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.

    12 months

  • 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.

    12 months

Secondary Outcomes (1)

  • Adequacy of Dialysis

    12 months

Study Arms (2)

Control graft

ACTIVE COMPARATOR

Conventional ePTFE hemodialysis graft

Device: Conventional ePTFE hemodialysis graft

HeRO Vascular Access Device

EXPERIMENTAL

HeRO Vascular Access Device

Device: HeRO Vascular Access Device

Interventions

HeRO Vascular Access DeviceDEVICE

HeRO Vascular Access Device

HeRO Vascular Access Device
Conventional ePTFE hemodialysis graftDEVICE

Conventional ePTFE hemodialysis graft

Control graft

Eligibility Criteria

Age22 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

St. Vincent's Medical Center

Los Angeles, California, 90057, United States

Location

University of Miami/Cedars Medical Center

Miami, Florida, 33125, United States

Location

St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Southern Illinois Unversity

Springfield, Illinois, 62702, United States

Location

Holy Cross Hospital

Rockville, Maryland, 20852, United States

Location

North Memorial Medical Center

Robbinsdale, Minnesota, 55422, United States

Location

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

Seton/Brackenridge Hospitals

Austin, Texas, 78703, United States

Location

Baylor Medical Center/Methodist Hospital

Houston, Texas, 77030, United States

Location

Baptist Medical Center

San Antonio, Texas, 78205, United States

Location

Sentara Heart Hospital

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

  • 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.

    PMID: 24428351RESULT

Limitations and Caveats

Due to slow enrollment and early termination of the study, a shortcoming of this trial, a final conclusion on equivalency between the HeRO Graft and conventional AV graft could not be firmly established.

Results Point of Contact

Title
George M. Nassar M.D.
Organization
Houston Methodist Hospital
georgemnassar@gmail.com
713-790-1963

Study Officials

  • Marc Glickman, MD

    Sentara Heart Hospital, Norfolk, VA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 29, 2009

Study Start

July 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

January 29, 2024

Results First Posted

June 9, 2021

Record last verified: 2024-01

Locations

US(11)