A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

The Hemoaccess Valve System (HVS) is a subcutaneous valve device that is implanted when a new AV graft is placed. A saline pump delivers fluid 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 dialysis technician deflates the valves and allows 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01644526
Study type	Interventional
Source	Diaxamed LLC
Contact
Status	Terminated
Phase	N/A
Start date	January 2016
Completion date	July 31, 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms