Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

University of South Florida

Status

Withdrawn

Conditions

Arteriovenous Fistula

Treatments

Device: AV Fistula creation with sutures

Device: AV Fistula creation with clips

Study type

Interventional

Funder types

Other

Identifiers

NCT03024372

Sutures vs Clips AVF

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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