A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In Patients Requiring Arteriovenous Graft Placement
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2009 |
| End Date: | April 2014 |
| Contact: | Hugh H Trout, MD |
| Email: | hhtrout@gmail.com |
| Phone: | 301-529-7815 |
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.
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.
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.
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.
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.
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