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

Stopped early · Not applicable

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT01644526

Run by

Diaxamed LLC

People needed

6

Starts

2016-01-01

Expected to finish

2017-07-31

Last updated by the study team

2018-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 proximity of study centers
• 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.

You may not qualify if…

• 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
• 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.

Where it is running

• Robert Scribner — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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