Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation
- Conditions
- Arteriovenous Fistula
- Interventions
- Device: AV Fistula creation with suturesDevice: AV Fistula creation with clips
- Registration Number
- NCT03024372
- Lead Sponsor
- University of South Florida
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional sutures AV Fistula creation with sutures AV fistula creation with sutures Anastoclips AV Fistula creation with clips AV fistula creation with clips
- Primary Outcome Measures
Name Time Method Time to loss of primary patency one year post surgery
- Secondary Outcome Measures
Name Time Method Time to functional maturation one year post surgery in patients on dialysis
Time to assumed maturation one year post surgery in patients not on dialysis
Operative cost duration of surgery Time to loss of secondary patency 5 years post surgery Rate of functional maturation one year post surgery in patients on dialysis
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
Time to loss of primary patency 5 years post surgery Rate of assumed maturation one year post surgery in patients not on dialysis
Rate of intervention five years post surgery to maintain patency
Time to loss of assisted primary patency 5 years post 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
Trial Locations
- Locations (3)
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of South Florida - South Tampa Campus
🇺🇸Tampa, Florida, United States
USF Health Carol and Frank Morsani Center for Advanced Healthcare
🇺🇸Tampa, Florida, United States