End-stage Kidney DiseaseOPENNCT01921933
The Optiflow Patency and Maturation Study
A study testing Optiflow in people with End-stage Kidney Disease and End-stage Renal Disease, run by Bioconnect Systems, Inc at 1 site in United States.
Trial summary
The objective of this study is to assess the performance and safety of the Optiflow Anastomotic Connector (Optiflow) when used to facilitate the creation of autogenous arteriovenous fistula (AVF) anastomoses. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End-stage Kidney Disease, End-stage Renal Disease
- What is being tested?
- Optiflow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jan 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive age).
- Life expectancy of at least one year, per the investigator's opinion.
- Diagnosed with ESRD or chronic kidney disease requiring dialysis.
- Planned upper extremity autogenous arteriovenous fistula.
- Planned anastomosis is an end of vein to side of artery configuration.
- AVF target artery and vein inner diameters are greater or equal to 3.0 mm and less than or equal to 7.0 mm as determined by pre-operative ultrasound and confirmed intra-operatively.
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- Patient is available and willing to return for follow-up visits during the duration of the study.
- Patient is able and willing to follow a daily aspirin and/or other anticoagulation/antiplatelet regimen not including warfarin (see exclusion criteria).
- Patient, or their legal representative, is willing and able to provide informed consent.
Who cannot join
- Known bleeding diathesis or coagulation disorder.
- Documented or suspected central venous stenosis.
- Uncontrolled hypotension with systolic blood pressures < 100 mg Hg at the time of screening.
- Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3.
- Body Mass Index (BMI) > 42.
- Transposition of the access vein is anticipated within the 90 day follow-up interval.
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- Receiving anticoagulant therapy for non-cardiac indications.
- Evidence or history of an active or suspected infection within one month of screening.
- Scheduled kidney transplant within six months of enrollment.
- History of ≥ 2 AVF and/or synthetic access graft failures.
- History of steal syndrome from a previous hemodialysis vascular access which required intervention or abandonment.
- Current participation in another clinical trial (excluding retrospective studies or studies not requiring a consent form).
- Anticipated surgery requiring general anesthesia during the course of follow-up.
- A history of substance abuse.
- Anticipated to be non-compliant with medical care or study requirements based on investigator judgment.
- Need for immunosuppressive therapy at a dose greater than the equivalent of prednisone 10 mg per day.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati - Division of Nephrology
Cincinnati, Ohio, 45267-0585
About this study
Official title: The "OPEN" Study Optiflow PatEncy and MaturatioN
The objective of this study is to assess the performance and safety of the Optiflow Anastomotic Connector (Optiflow) when used to facilitate the creation of autogenous arteriovenous fistula (AVF) anastomoses.
Read the detailed description
The investigation is designed as a multi-center, prospective, single-arm, clinical study of the Optiflow performance and safety in a maximum of 180 subjects which includes one (1) roll-in subjects per investigator (maximum of 36 roll-in subjects). Subjects will be followed at 14 days post-procedure, 42 days post-procedure, and 90 days post-procedures.
Results will be compared to a pre-established performance goal.
Up to fifteen (15) investigational sites will participate in the investigational study.
The primary performance endpoint is the overall maturation percentage rate at 90 days. Maturation is defined as an access site which achieves a diameter of greater or equal to 4 mm and blood flow greater or equal t0 500 mL/min as measured via duplex ultrasound.
The primary safety endpoint is a composite endpoint of serious adverse events known to be associated with arteriovenous fistula anastomosis surgical procedures through 90 days.
- Conditions
- End-stage Kidney Disease, End-stage Renal Disease
- Being tested
- Optiflow
- Keywords
- End-stage renal disease, ESRD, AVF, Fistulas
- Medical subject headings
- Kidney Failure, Chronic, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiflowDevice
Also called Optiflow Anastomotic Connector
The Optiflow device will be implanted in the upper extremity of Adult end-stage renal disease (ESRD) patients requiring creation of an upper extremity autogenous arteriovenous fistula for dialysis access.
| Study group | Role | What they receive |
|---|---|---|
| Optiflow | Experimental | The Optiflow device will be implanted in the upper extremity of Adult end-stage renal disease (ESRD) patients requiring creation of an upper extremity autogenous arteriovenous fistula for dialysis access. Receives: Device: Optiflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula Maturation
The primary performance endpoint is the maturation percentage rate at 90 days. Maturation is defined as an access site intended for dialysis needle cannulation which achieves a diameter of greater or equal to 4 mm and blood flow greater or equal to 500 mL/min as measured via duplex ultrasound.
Measured: 90 days
Serious Adverse Events Associated with Arteriovenous Fistula Creation
The primary safety endpoint is a composite endpoint of serious adverse events known to be associated with arteriovenous fistula anastomosis surgical procedures through 90 days. All patients will be followed for safety for the duration of the study.
Measured: 90 days
Secondary outcomes (6)
Technical success
Technical success rate: An access site that demonstrates physical exam patency through hospital discharge.
Measured: 1 day
Assisted Maturation
Assisted maturation rate: An access site which achieves or maintains maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation.
Measured: 90 days
Unassisted Maturation
Unassisted fistula maturation rate: An access site that achieves and maintains maturation without any surgical or endovascular intervention designed to promote or reestablish Maturation.
Measured: 90 days
Assisted Patency
Assisted patency rate: An access site which is patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency.
Measured: 90 days
Unassisted Patency
Unassisted patency rate: An access site that maintains patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site.
Measured: 90 days
Intervention Rate
Intervention rate: The number of occurrences that a subject's access site is surgically or endovascularly operated on to maintain or reestablish blood flow in the access site.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startFeb 2014
- Primary completionOct 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Kidney 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioconnect Systems, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921933
- Sponsor's protocol ID
- BCS_TP1070
- Acronym
- OPEN
- Status last verified
- Jan 2016
- First submitted
- 9 Aug 2013
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "OPEN" Study Optiflow PatEncy and MaturatioN
- ClinicalTrials.gov ID
- NCT01921933
- Acronym / sponsor ID
- OPEN / BCS_TP1070
- Conditions
- End-stage Kidney Disease, End-stage Renal Disease
- Keywords
- End-stage renal disease, ESRD, AVF, Fistulas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Bioconnect Systems, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Aug 2013 (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 objective of this study is to assess the performance and safety of the Optiflow Anastomotic Connector (Optiflow) when used to facilitate the creation of autogenous arteriovenous fistula (AVF) anastomoses.
Detailed description
The investigation is designed as a multi-center, prospective, single-arm, clinical study of the Optiflow performance and safety in a maximum of 180 subjects which includes one (1) roll-in subjects per investigator (maximum of 36 roll-in subjects). Subjects will be followed at 14 days post-procedure, 42 days post-procedure, and 90 days post-procedures.
Results will be compared to a pre-established performance goal.
Up to fifteen (15) investigational sites will participate in the investigational study.
The primary performance endpoint is the overall maturation percentage rate at 90 days. Maturation is defined as an access site which achieves a diameter of greater or equal to 4 mm and blood flow greater or equal t0 500 mL/min as measured via duplex ultrasound.
The primary safety endpoint is a composite endpoint of serious adverse events known to be associated with arteriovenous fistula anastomosis surgical procedures through 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optiflow | Experimental | Device: OptiflowThe Optiflow device will be implanted in the upper extremity of Adult end-stage renal disease (ESRD) patients requiring creation of an upper extremity autogenous arteriovenous fistula for dialysis access. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive age).
- Life expectancy of at least one year, per the investigator's opinion.
- Diagnosed with ESRD or chronic kidney disease requiring dialysis.
- Planned upper extremity autogenous arteriovenous fistula.
- Planned anastomosis is an end of vein to side of artery configuration.
Key exclusion criteria (16 listed)
- Known bleeding diathesis or coagulation disorder.
- Documented or suspected central venous stenosis.
- Uncontrolled hypotension with systolic blood pressures < 100 mg Hg at the time of screening.
- Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3.
- Body Mass Index (BMI) > 42.
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 |
|---|---|---|
| OptiflowAlso: Optiflow Anastomotic ConnectorThe Optiflow device will be implanted in the upper extremity of Adult end-stage renal disease (ESRD) patients requiring creation of an upper extremity autogenous arteriovenous fistula for dialysis access. | Device | Optiflow |
Primary outcome
Fistula Maturation
Time frame: 90 days
The primary performance endpoint is the maturation percentage rate at 90 days. Maturation is defined as an access site intended for dialysis needle cannulation which achieves a diameter of greater or equal to 4 mm and blood flow greater or equal to 500 mL/min as measured via duplex ultrasound.
Serious Adverse Events Associated with Arteriovenous Fistula Creation
Time frame: 90 days
The primary safety endpoint is a composite endpoint of serious adverse events known to be associated with arteriovenous fistula anastomosis surgical procedures through 90 days. All patients will be followed for safety for the duration of the study.
6 secondary outcomes
Technical success
Time frame: 1 day
Assisted Maturation
Time frame: 90 days
Unassisted Maturation
Time frame: 90 days
Assisted Patency
Time frame: 90 days
Unassisted Patency
Time frame: 90 days
Intervention Rate
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optiflow in people with End-stage Kidney Disease and End-stage Renal Disease, run by Bioconnect Systems, Inc 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 9 inclusion and 16 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: finished, as of the sponsor's last update on 12 Jan 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fistula Maturation (time frame: 90 days). The study lists 2 primary outcomes in all. 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 12 Jan 2016; AzTrials last refreshed its copy on 29 Oct 2026.