A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In Patients Requiring Arteriovenous Graft Placement

January 31, 2018 updated by: Diaxamed LLC
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The Hemoaccess Valve System (HVS) is a subcutaneous valve device that is implanted when a new AV graft is placed. A saline pump delivers fluid to the arterial balloon valve and closes that end of the graft off to blood flow. Using the dialysis blood lines, saline flushes residual blood from the graft back into the body. Then the venous balloon valve closes and heparinized saline resides in the graft between dialysis sessions.

When the patient returns for dialysis, the dialysis technician deflates the valves and allows blood to flow to the graft for dialysis. (The saline inside the graft simply enters the blood stream.)

By only having saline inside the AV graft between dialysis sessions, there is no post-dialysis bleeding where the dialysis needles were cannulated, and because blood flow is restored to its normal course in the vein and artery, the traditional turbulent blood flow through the graft is eliminated, reducing the traditional complications caused when arterial blood is diverted through the graft then into the vein.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Robert Scribner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 3 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemoaccess Valve System
Valve system for use with AV graft
Device: Hemoaccess Valve System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unassisted patency rate
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eliminate Post-Dialysis Needle Site Bleeding
Time Frame: 12 months

Outcome measure: Reduce post-dialysis needle site bleeding by 95%.

Currently most dialysis patients experience mild to severe post-dialysis bleeding when the large (15 gauge) dialysis needles are removed from their AV graft. The HVS device shuts off blood flow to the graft after dialysis therefore no post-dialysis bleeding should be experienced.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diaxamed LLC

Investigators

  • Study Director: Robert Scribner, CEO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

April 3, 2012

First Submitted That Met QC Criteria

July 18, 2012

First Posted (Estimate)

July 19, 2012

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVM-HVS-Phase I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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