OPEN: The Optiflow Patency and Maturation Study

Sponsor

Bioconnect Systems, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01921933

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
End-stage Kidney Disease End-stage Renal Disease	Device: Optiflow	N/A

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

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The "OPEN" Study Optiflow PatEncy and MaturatioN

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Optiflow 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.	Device: Optiflow 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. Other Names: Optiflow Anastomotic Connector

Arm

Intervention/Treatment

Experimental: Optiflow

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.

Device: Optiflow

Other Names:

Optiflow Anastomotic Connector

Outcome Measures

Primary Outcome Measures

Fistula Maturation [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 [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.

Secondary Outcome Measures

Technical success [1 day]
Technical success rate: An access site that demonstrates physical exam patency through hospital discharge.
Assisted Maturation [90 days]
Assisted maturation rate: An access site which achieves or maintains maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation.
Unassisted Maturation [90 days]
Unassisted fistula maturation rate: An access site that achieves and maintains maturation without any surgical or endovascular intervention designed to promote or reestablish Maturation.
Assisted Patency [90 days]
Assisted patency rate: An access site which is patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency.
Unassisted Patency [90 days]
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.
Intervention Rate [90 days]
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.

Other Outcome Measures

Time to first cannulation [Up to 90 days]
Elapsed time to first use of access site.
Ultrasound flow [90 days]
Flow rate of blood through outflow vein
Time To Access Site Abandonment [Up to 90 days]
Elapsed time to abandonment of the access site.
Access Site Related Adverse Events [90 days]
The number of access related adverse events per subject
Number of Access Site Related Hospitalizations [90 days]
The number of access site related hospitalizations per subject.
Catheter Utilization [90 days]
Total number of days a catheter was used before access site maturation per subject.
Total Adverse Events [90 days]
Total number of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
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.

Exclusion Criteria:

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.
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.