The Optiflow Patency and Maturation Study

Completed · Not applicable

Conditions studied: End-stage Kidney Disease, End-stage Renal Disease

In brief

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.

Key facts

Study ID

NCT01921933

Run by

Bioconnect Systems, Inc

People needed

51

Starts

2014-02-01

Expected to finish

2016-01-01

Last updated by the study team

2016-01-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Cincinnati - Division of Nephrology — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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