A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In Patients Requiring Arteriovenous Graft Placement
|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|
- 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.
- 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.
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644526
|United States, South Carolina|
|Greenville, South Carolina, United States, 29615|
|Principal Investigator:||Hugh H Trout, MD||Vascular surgeon at Greenville Hospital System|