The Optiflow Patency and Maturation Study (OPEN)

Bioconnect Systems

Status: Completed

Conditions: End-stage Kidney Disease; End-stage Renal Disease

Treatments: Device: Optiflow

Study type: Interventional

Funder types: Industry

Identifiers

NCT01921933

BCS_TP1070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Optiflow

Experimental group

Description:

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.

Treatment:

Device: Optiflow