Clinical trial NCT03024372: Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation
Official title: A Prospective Randomized Single Blinded Study of Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Arteriovenous Fistula
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to loss of primary patency
timeFrame: one year post surgery
Secondary outcomes:
measure: Time to loss of secondary patency
timeFrame: one year post surgery
measure: Time to loss of assisted primary patency
timeFrame: one year post surgery
measure: Rate of functional maturation
timeFrame: one year post surgery
measure: Time to functional maturation
timeFrame: one year post surgery
measure: Rate of assumed maturation
timeFrame: one year post surgery
measure: Time to assumed maturation
timeFrame: one year post surgery
measure: Rate of complications
timeFrame: 30 days post surgery
measure: Rate of intervention
timeFrame: five years post surgery
measure: Operative cost
timeFrame: duration of surgery
measure: Overall cost
timeFrame: time of surgery to time of hospital discharge (can range from 1 day to 1 week or more)
measure: Time to loss of primary patency
timeFrame: 5 years post surgery
measure: Time to loss of assisted primary patency
timeFrame: 5 years post surgery
measure: Time to loss of secondary patency
timeFrame: 5 years post surgery
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida - South Tampa Campus
state: Florida
city: Tampa
country: United States
facility: USF Health Carol and Frank Morsani Center for Advanced Healthcare
state: Florida
Study officials:
affiliation: University of South Florida
name: Karl Illig, MD
role: PRINCIPAL_INVESTIGATOR
References:
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