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

This study has been terminated.
(An enhanced device has been developed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01644526
First Posted: July 19, 2012
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Diaxamed LLC
  Purpose
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.

Condition Intervention
End Stage Renal Disease Device: Hemoaccess Valve System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In Patients Requiring Arteriovenous Graft Placement

Further study details as provided by Diaxamed LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 6
Actual Study Start Date: January 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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, about the size of a quarter, contains a small magnetic platform which couples with an external handheld device. Inside the handheld device, a magnetic wheel rotates and because it is coupled with the implanted device, also activates the subcutaneous saline pump. Saline first travels 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 external handheld device is held over the subcutaneous pump and saline in the balloon valves is returned to its reservoir, deflating the valves and allowing 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644526


Locations
United States, South Carolina
Robert Scribner
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Diaxamed LLC
Investigators
Principal Investigator: Hugh H Trout, MD Vascular surgeon at Greenville Hospital System
  More Information

Responsible Party: Diaxamed LLC
ClinicalTrials.gov Identifier: NCT01644526     History of Changes
Other Study ID Numbers: CVM-HVS-Phase I
First Submitted: April 3, 2012
First Posted: July 19, 2012
Last Update Posted: September 12, 2017
Last Verified: September 2017

Keywords provided by Diaxamed LLC:
dialysis
vascular access
arteriovenous grafts
valve system

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases