Patient-Centered Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas

Primary Aim: To compare the primary endpoint event rates in patients with ESRD and candidates for a new BBAVF randomized to have one-stage or two-stage BBAVF procedure.

Primary Endpoint: Primary Clinical Functional Patency, defined as the successful use of the index BBAVF with two needles for 75% of dialysis sessions over a continuous 4-week period without any endovascular or surgical procedure on the fistula (modified from the HFM study).Time to first occurrence of a qualifying clinical event will be compared utilizing follow-up at 6-month and 12-month after fistula creation (minimum of 12-month/subject).

Secondary Aims: To compare the secondary endpoints (Fistula-related, CVC-related, and composite clinicaloutcomes) of subjects randomizing to one-stage or two-stage BBAVF procedure. CVC-related events will be calculated from the index procedure in the one-stage approach and the first procedure for the two-stage BBAVF approach.

Secondary Endpoints: 1) Fistula-related outcome: stenosis and thrombosis, infection, arm swelling, hand ischemia, surgery or intervention, and hospitalization; 2) CVC-related outcome: duration of dependency, infection, bacteremia, and additional CVC procedure (exchange, placement of new CVC); and 3) Composite outcomes of Primary Clinical Functional Patency or CVC-related bacteremia or death.

Hypothesis: Primary Clinical Functional Patency will be superior following two-stage compared to one-stage BBAVF procedure. CVC-related complications will be higher following two-stage compared to one-stage BBAVf procedure the investigator will recruit 60 subjects aged 18 years or older with ESRD who will undergo a BBAVF. Thirty subjects will be randomized in the one-stage approach and 30 subjects in the two-stage approach. The expectation for enrollment is 1 subject/month/site, and the recruitment period will be for 12 months.

Inclusion criteria (all must be present for inclusion): 1. Age ≥ 18 years; 2. ESRD receiving hemodialysis (CVC) in need for new hemodialysis access; 3. Candidate for one-stage and two-stage BVT procedure as judged by the enrolling investigator; 4. Greater than 3 mm diameter of upper arm basilic vein on venous duplex scan; 5.Life expectancy ≥ 12 months; 6. Anticipated ability to comply with study procedures;

Exclusion criteria (none of these can be met for inclusion):

1. Life expectancy < 12 months;
2. Brachial artery stenosis or occlusion;
3. A documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis);
4. Current immunosuppressive medication, chemotherapy or radiation therapy;
5. Pregnancy or lactation