Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation
Withdrawn before enrolling · Not applicable
Conditions studied: Arteriovenous Fistula
In brief
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.
Key facts
- Study ID
- NCT03024372
- Run by
- University of South Florida
- People needed
- 0
- Starts
- 2017-12-01
- Expected to finish
- 2024-08-01
- Last updated by the study team
- 2018-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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