A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In Patients Requiring Arteriovenous Graft Placement
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.
|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|
- 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.
- 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.
|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)|
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.
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.
|Contact: Hugh H Trout, MDemail@example.com|
|Contact: David Cull, MDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Medicine Suburban Hospital||Recruiting|
|Bethesda, Maryland, United States, 20814|
|Contact: Jackie Lobien, RN 301-896-3122 email@example.com|
|Contact: Hugh H Trout, MD 301-529-7815 firstname.lastname@example.org|
|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 email@example.com|
|Contact: David Cull, MD 864-420-8714 firstname.lastname@example.org|
|Principal Investigator: Christopher Carsten, MD|
|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)|