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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by CreatiVasc Medical LLC
Sponsor:
Information provided by (Responsible Party):
CreatiVasc Medical LLC
ClinicalTrials.gov Identifier:
NCT01644526
First received: April 3, 2012
Last updated: January 29, 2013
Last verified: January 2013
  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 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's valves are activated, shutting off the flow of blood through the graft. The graft is then flushed with sterile saline using the dialysis blood lines. 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 with having blood diverted through the graft 24/7.


Condition Intervention Phase
End Stage Renal Disease
Device: Hemoaccess Valve System
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In Patients Requiring Arteriovenous Graft Placement

Resource links provided by NLM:


Further study details as provided by CreatiVasc Medical LLC:

Primary Outcome Measures:
  • Reduce AV graft thrombosis and associated interventions [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Determine if the ability to limit blood flow to an AV graft only when it is needed for dialysis will reduce current repetitive thromboses by a minimum of 50% in the graft due to continuous blood flow through it. 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: 4 months ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 12
Study Start Date: April 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hemoaccess Valve System
Valve system for use with arteriovenous (AV) graft for vascular access in dialysis patients.
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. It consists of a silicone port into which 3cc of sterile saline is injected. The fluid travels through connective tubing to two balloon valves which expand inside small rigid cuffs which surround the end ends of the graft at the venous and arterial anastomoses. The expansion of the balloons inside the cuffs close off the graft to blood flow. Once the graft is closed off, blood inside the graft is flushed out with sterile saline and using the dialysis needles which are still in place in the graft at the end of dialysis. Once the graft is cleared of blood, the sterile saline along with heparin remain in the graft between dialysis sessions. At the next dialysis session, the 3cc of saline in the balloon valves is aspirated out, 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 Greenville, SC or Bethesda, MD
  • 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
  • They are a candidate for a natural fistula
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644526

Contacts
Contact: Hugh H Trout, MD 301-529-7815 hhtrout@gmail.com
Contact: David Cull, MD 864-420-8714 dcull@ghs.org

Locations
United States, Maryland
Johns Hopkins Medicine Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Contact: Jackie Lobien, RN    301-896-3122    jlobien@suburbanhospital.org   
Contact: Hugh H Trout, MD    301-529-7815    hhtrout@gmail.com   
Principal Investigator: Hugh H Trout, MD         
United States, South Carolina
Greenville Memorial Hospital System University Medical Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Christopher Carsten, MD    864-454-8272    ccarsten@ghs.org   
Contact: David Cull, MD    864-420-8714    dcull@ghs.org   
Principal Investigator: Christopher Carsten, MD         
Sponsors and Collaborators
CreatiVasc Medical LLC
Investigators
Principal Investigator: Christopher Carsten, MD Vascular surgeon at Greenville Hospital System
Principal Investigator: Hugh Trout III, MD Vascular Surgeon in Washington, DC and Bethesda, MD area + Clinical Advisor to the Sponsor (unpaid)
  More Information

No publications provided

Responsible Party: CreatiVasc Medical LLC
ClinicalTrials.gov Identifier: NCT01644526     History of Changes
Other Study ID Numbers: CVM-HVS-Phase I
Study First Received: April 3, 2012
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 28, 2014