Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

This will be a single blind (patient and dialysis center), prospective, randomized trial
conducted at a single center. The study intervention will be randomization between
conventional sutured anastomosis (Control group) and use of Anastoclips (Treatment group),
which provide an interrupted closure without intimal penetration.

Inclusion Criteria:

- Requiring brachiocephalic fistula judged to be best option for access after vein
mapping (Surgeons will be required to do 10 cases using Anastoclips prior to
enrolling)

- Able to provide informed consent in English or Spanish

- Age 18 years or greater

- With estimated life expectancy of 2 years or more

- Able to comply with study procedures including all scheduled follow-up visits

Exclusion Criteria:

- Unable to provide informed consent in English or Spanish

- Age < 18 years

- With pacemaker, IACD, or other permanent obstructive device on that side (a temporary
tunneled dialysis catheter is not an exclusion)

- Unable (or in surgeon's judgment a poor risk) to comply with study procedures and
follow-up visits

- With estimated life expectancy of less than 2 years

- Females must be either:

- Of non-childbearing potential, which is defined as post-menopausal (at least 12
months without menses prior to Treatment Day) or documented surgically sterile or
post hysterectomy (at least 1 month prior to Treatment Day)

- Or, of childbearing potential, in which case must have a negative urine pregnancy
test at Treatment Day