Arteriovenous Fistula
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICEAV Fistula creation with sutures
End-to-side anastomosis (of AV fistula) is to be constructed using sutures. The incision is to be irrigated and closed using Vicryl, Biosyn and skin glue.
DEVICEAV Fistula creation with clips
End-to-side anastomosis (of AV fistula) is to be constructed using clips. The incision is to be irrigated and closed using Vicryl, Biosyn and skin glue.
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to loss of primary patency | one year post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to assumed maturation | one year post surgery | in patients not on dialysis |
| Time to functional maturation | one year post surgery | in patients on dialysis |
| Time to loss of secondary patency | one year post surgery | — |
| Time to loss of assisted primary patency | one year post surgery | — |
| Rate of functional maturation | one year post surgery | in patients on dialysis |
| Rate of assumed maturation | one year post surgery | in patients not on dialysis |
| Rate of intervention | five years post surgery | to maintain patency |
| Operative cost | duration of surgery | — |
| Overall cost | time of surgery to time of hospital discharge (can range from 1 day to 1 week or more) | Overall cost of surgery itself defined as from surgery to point of hospital discharge, anticipated to be in days |
| Time to loss of primary patency | 5 years post surgery | — |
| Rate of complications | 30 days post surgery | thrombosis/thrombectomy, stenosis, skin erosion, limb swelling, steal syndrome, bleeding and hematoma formation at surgical site, surgical-site-related infection, access-related infection, rupture, revision |
Countries
United States
Outcome results
None listed