Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

Study Overview
=================
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.

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

Conditions
-----------------
Arteriovenous Fistula

Intervention / Treatment
-----------------
* Device: AV Fistula creation with sutures
* Device: AV Fistula creation with clips


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional sutures<br>AV fistula creation with sutures | Device: AV Fistula creation with sutures<br>* 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.<br>|
| Active Comparator: Anastoclips<br>AV fistula creation with clips | Device: AV Fistula creation with clips<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to loss of primary patency |  | one year post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | in patients on dialysis | one year post surgery | 
| Time to functional maturation | in patients on dialysis | one year post surgery | 
| Rate of assumed maturation | in patients not on dialysis | one year post surgery | 
| Time to assumed maturation | in patients not on dialysis | one year post surgery | 
| Rate of complications | 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 | 30 days post surgery | 
| Rate of intervention | to maintain patency | five years post surgery | 
| Operative cost |  | duration of surgery | 
| Overall cost | Overall cost of surgery itself defined as from surgery to point of hospital discharge, anticipated to be in days | time of surgery to time of hospital discharge (can range from 1 day to 1 week or more) | 
| Time to loss of primary patency |  | 5 years post surgery | 
| Time to loss of assisted primary patency |  | 5 years post surgery | 
| Time to loss of secondary patency |  | 5 years post surgery |