End Stage Renal DiseaseNCT01644526
A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In Patients Requiring Arteriovenous Graft Placement
A study testing Hemoaccess Valve System in people with End Stage Renal Disease, run by Diaxamed LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Hemoaccess Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- End Stage Renal Disease
- Being tested
- Hemoaccess Valve System
- Keywords
- dialysis, vascular access, arteriovenous grafts, valve system
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoaccess Valve SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemoaccess Valve System | Experimental | Valve system for use with AV graft Receives: Device: Hemoaccess Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unassisted patency rate
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.
Measured: 12 months
Secondary outcomes (1)
Eliminate Post-Dialysis Needle Site Bleeding
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startJan 2016
- Primary completion30 Jun 2017
- Study completion31 Jul 2017
Why it stopped: An enhanced device has been developed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diaxamed LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Scribner, Study director, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644526
- Sponsor's protocol ID
- CVM-HVS-Phase I
- Status last verified
- Jan 2018
- First submitted
- 3 Apr 2012
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In Patients Requiring Arteriovenous Graft Placement
- ClinicalTrials.gov ID
- NCT01644526
- Acronym / sponsor ID
- CVM-HVS-Phase I
- Conditions
- End Stage Renal Disease
- Keywords
- dialysis, vascular access, arteriovenous grafts, valve system
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An enhanced device has been developed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Diaxamed LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemoaccess Valve System | Experimental | Device: Hemoaccess Valve SystemValve system for use with AV graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemoaccess Valve SystemDevice 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. | Device | Hemoaccess Valve System |
Primary outcome
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.
1 secondary outcome
Eliminate Post-Dialysis Needle Site Bleeding
Time frame: 12 months
Results and safety
The study was stopped early (reason given: An enhanced device has been developed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
Related trials for End Stage Renal Disease
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Active, not recruitingObservational study
Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)
Kidney Failure, Chronic
Active, not recruitingObservational study
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
End Stage Renal Disease
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Scribner study director
CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemoaccess Valve System in people with End Stage Renal Disease, run by Diaxamed LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: An enhanced device has been developed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unassisted patency rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.