NCT01644526

Brief Summary

The ability to selectively control blood flow through an arteriovenous (AV) graft only when it is needed for dialysis may reduce the current repetitive complications such as thrombosis, venous hypertension post-dialysis bleeding, and blood steal from the extremities. The Hemoaccess Valve System (HVS) allows an AV graft to be turned on to blood flow when it is needed for dialysis then when dialysis is concluded, the device shuts off arterial blood flow and residual blood in the graft is flushed back into the body, using the dialysis blood lines. Once the graft is cleared of blood, the venous valve is then closed. Heparinized sterile saline reside in the graft between dialysis sessions. By having only saline in the graft and restoring normal blood flow to the artery and vein, it is believed that this will dramatically reduce the current complications associated with now having blood diverted through the graft 24/7.

Trial Health

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Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
3.5 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

1.5 years

First QC Date

April 3, 2012

Last Update Submit

January 31, 2018

Conditions

End Stage Renal Disease

Keywords

dialysisvascular accessarteriovenous graftsvalve system

Outcome Measures

Primary Outcomes (1)

  • Unassisted patency rate

    Determine if the ability to limit blood flow to an AV graft only when it is needed for dialysis will increase unassisted patency rate of the test arm by a minimum of 50%. The New England Journal of Medicine study, "Effect of Dipyridamole plus Aspirin on Hemodialysis Graft Patency" (NEJM 360;21, 5/21/09) indicated a 1 year unassisted patency rate of 23% (77% required intervention). Our objective is to determine if the intervention rate can be reduced to 38-39% during the study, a 50% reduction in the expected intervention rate.

    12 months

Secondary Outcomes (1)

  • Eliminate Post-Dialysis Needle Site Bleeding

    12 months

Study Arms (1)

Hemoaccess Valve System

EXPERIMENTAL

Valve system for use with AV graft

Device: Hemoaccess Valve System

Interventions

Hemoaccess Valve SystemDEVICE

Device that allows blood to selectively flow into an arteriovenous graft to provide vascular access for dialysis then turn off the flow of blood to the graft in between dialysis sessions.

Hemoaccess Valve System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be a candidate for a new arteriovenous graft
  • Be either currently on dialysis or ready to begin dialysis as soon as the access device (AV graft with Hemoaccess Valve System) is ready for use.
  • Be prepared to receive dialysis at dialysis centers in proximity of study centers
  • Have an outflow vein of greater than or equal to 3mm in diameter to which the graft can be successfully anastomosed.
  • Be able to communicate with study personnel.
  • Be considered by the physician to be readily available for subsequent visits.
  • Be willing to comply with all aspects of the treatment and evaluation as directed over the duration of the study.
  • Allow representatives of the Sponsor, the designated Clinical Research Organization, the Institutional Review Board and the FDA to review his/her relevant medical records that pertain to this study.

You may not qualify if:

  • An identification of a central venous stenosis on the ipsilateral side is documented or otherwise identified
  • An identification of an arterial venous stenosis on the ipsilateral side is documented or otherwise identified
  • A hypercoagulable state is documented or otherwise identified and/or previous AV access failures have occurred without an identifiable cause.
  • Has a life expectancy of less than one year.
  • An immunodeficiency syndrome
  • An organ transplant is expected within 6 months of enrollment
  • or more previous new AV graft or fistula placements have occurred.
  • Body habitus (e.g., extremely small or obese arms( precludes HVS device implantation or access.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Scribner

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Scribner

    CEO

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2012

First Posted

July 19, 2012

Study Start

January 1, 2016

Primary Completion

June 30, 2017

Study Completion

July 31, 2017

Last Updated

February 5, 2018

Record last verified: 2018-01

Locations

US(1)