Renal Failure Chronic Requiring HemodialysisNCT00890045

Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

A study testing HeRO Vascular Access Device and Conventional ePTFE hemodialysis graft in people with Renal Failure Chronic Requiring Hemodialysis, run by Merit Medical Systems, Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Compare the HeRO Vascular Access Device to a conventional ePTFE graft. Read more about this study

Who is it for?: Ages 22 to 99 years
Conditions the study is for: Renal Failure Chronic Requiring Hemodialysis
What is being tested?: HeRO Vascular Access Device and Conventional ePTFE hemodialysis graft
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 11 sitesUnited States
Study dates: Jul 2004to Mar 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Show all 12Show fewer

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.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

St. Joseph's Hospital
Atlanta, Georgia, 30342
Seton/Brackenridge Hospitals
Austin, Texas, 78703
Duke Medical Center
Durham, North Carolina, 27710
Baylor Medical Center/Methodist Hospital
Houston, Texas, 77030
St. Vincent's Medical Center
Los Angeles, California, 90057
University of Miami/Cedars Medical Center
Miami, Florida, 33125
Sentara Heart Hospital
Norfolk, Virginia, 23507
North Memorial Medical Center
Robbinsdale, Minnesota, 55422
Holy Cross Hospital
Rockville, Maryland, 20852
Baptist Medical Center
San Antonio, Texas, 78205
Southern Illinois Unversity
Springfield, Illinois, 62702

Other trials in United States

About this study

Official title: A Comparison Between the HeRO® Graft and Conventional Arteriovenous Grafts in Hemodialysis Patients

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

Read the 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.

Conditions: Renal Failure Chronic Requiring Hemodialysis
Being tested: HeRO Vascular Access Device, Conventional ePTFE hemodialysis graft
Keywords: Vascular access hemodialysis, ePTFE graft, Graft-eligible, Long-term vascular access for hemodialysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HeRO Vascular Access DeviceDevice
HeRO Vascular Access Device
Conventional ePTFE hemodialysis graftDevice
Conventional ePTFE hemodialysis graft

Study groups in NCT00890045
Study group	Role	What they receive
Control graft	Active comparator	Conventional ePTFE hemodialysis graft Receives: Device: Conventional ePTFE hemodialysis graft
HeRO Vascular Access Device	Experimental	HeRO Vascular Access Device Receives: Device: HeRO Vascular Access Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2004Mar 2008

First posted29 Apr 2009 (estimated)
Study startJul 2004
Primary completionMar 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal Failure Chronic Requiring HemodialysisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00890045
Sponsor's protocol ID: 11-0004
Status last verified: Jan 2024
First submitted: 27 Apr 2009
Last updated: 29 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 24428351

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison Between the HeRO® Graft and Conventional Arteriovenous Grafts in Hemodialysis Patients
ClinicalTrials.gov ID: NCT00890045
Acronym / sponsor ID: 11-0004
Conditions: Renal Failure Chronic Requiring Hemodialysis
Keywords: Vascular access hemodialysis, ePTFE graft, Graft-eligible, Long-term vascular access for hemodialysis
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
Collaborators: CryoLife, Inc.
Study start: Jul 2004
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 29 Apr 2009 (estimated)
Results: Posted 9 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control graft	Active comparator	Device: Conventional ePTFE hemodialysis graftConventional ePTFE hemodialysis graft
HeRO Vascular Access Device	Experimental	Device: HeRO Vascular Access DeviceHeRO Vascular Access Device

Who may qualify

Ages: 22 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HeRO Vascular Access DeviceHeRO Vascular Access Device	Device	HeRO Vascular Access Device
Conventional ePTFE hemodialysis graftConventional ePTFE hemodialysis graft	Device	Control graft

Primary outcome

Percentage of Patients With Primary Patency
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

1 secondary outcome

Adequacy of Dialysis
Time frame: 12 months

Results and safety

Results posted to the registry on 9 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Graft	20	15
HeRO Vascular Access Device	52	42

Primary outcome: Percentage of Patients With Primary Patency

Time frame: 6 months, 12 months. Number (95% Confidence Interval). Unit: percentage of participants patent

Measure	Control Group n = 19	HeRO Group n = 49
6 Months	48.2 (25.1 to 68.0)	47.0 (32.7 to 60.1)
12 Months	30.6 (11.8 to 51.9)	34.8 (21.9 to 48.0)

Population analysed: The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date. Note: Of the 52 subjects randomized to the HeRO Graft, 50 subjects were successfully implanted. Two implants were abandoned.

Primary outcome: Percentage of Patients With Assisted Primary Patency

Time frame: 6 months, 12 months. Number (95% Confidence Interval). Unit: percentage of participants patent

Measure	Control Group n = 15	HeRO Group n = 36
6 Months	88.8 (62.1 to 97.1)	86.2 (71.7 to 93.6)
12 Months	75.2 (46.1 to 90.0)	79.8 (63.1 to 89.5)

Population analysed: The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date.

Primary outcome: Percentage of Patients With Secondary Patency

Time frame: 12 months. Number (95% Confidence Interval). Unit: percentage of participants patent

Measure	Control Group n = 19	HeRO Group n = 45
6 Months	58.4 (33.8 to 76.7)	76.7 (61.8 to 86.4)
12 Months	58.4 (33.8 to 76.7)	67.6 (52.0 to 79.1)

Population analysed: The denominator represents the number of subjects who are not lost to follow-up, withdrew or died prior to that visit window close date.

Primary outcome: Number of Patients With Serious Device or Implant Procedure-related Adverse Events

Time frame: 12 months. Number. Unit: participants

Measure	Control Group n = 20	HeRO Group n = 52
Bleeding, hemorrhage or hematoma	0	6
Death	0	1
Device technical failure	0	1
Embolism	0	2
Heart failure	1	0
Infection (non-BSIe)	2	2
Other	2	5
Site pain	0	1

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	5 of 20 (25%)	4 of 20 (20%)	Not reported
HeRO Group	19 of 52 (36.5%)	5 of 52 (9.6%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24428351Nassar 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marc Glickman, MD principal investigator

Sentara Heart Hospital, Norfolk, VA

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Primary Patency (time frame: 6 months, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00890045, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.