Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

A Prospective Randomized Single Blinded Study of Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

The purpose of this study is to investigate a promising strategy to improve maturation and patency rates following creation of AV fistulas and assess whether an anastomosis performed with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency than one performed with conventional suturing techniques.

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