Clinical trial NCT01921933: The Optiflow Patency and Maturation Study
Official title: The "OPEN" Study Optiflow PatEncy and MaturatioN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Kidney Disease
End-stage Renal Disease
Keywords: End-stage renal disease
ESRD
AVF
Fistulas
Lead sponsor: Bioconnect Systems, Inc
Sponsor class: INDUSTRY
First posted: 2013-08-14
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fistula Maturation
timeFrame: 90 days
measure: Serious Adverse Events Associated with Arteriovenous Fistula Creation
timeFrame: 90 days
Secondary outcomes:
measure: Technical success
timeFrame: 1 day
measure: Assisted Maturation
timeFrame: 90 days
measure: Unassisted Maturation
timeFrame: 90 days
measure: Assisted Patency
timeFrame: 90 days
measure: Unassisted Patency
timeFrame: 90 days
measure: Intervention Rate
timeFrame: 90 days
Other outcomes:
measure: Time to first cannulation
timeFrame: Up to 90 days
measure: Ultrasound flow
timeFrame: 90 days
measure: Time To Access Site Abandonment
timeFrame: Up to 90 days
measure: Access Site Related Adverse Events
timeFrame: 90 days
measure: Number of Access Site Related Hospitalizations
timeFrame: 90 days
measure: Catheter Utilization
timeFrame: 90 days
measure: Total Adverse Events
timeFrame: 90 days
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati - Division of Nephrology
state: Ohio
Study officials:
References: