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Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

Primary Purpose

Arteriovenous Fistula

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AV Fistula creation with sutures
AV Fistula creation with clips
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriovenous Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampa General Hospital
  • University of South Florida - South Tampa Campus
  • USF Health Carol and Frank Morsani Center for Advanced Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional sutures

Anastoclips

Arm Description

AV fistula creation with sutures

AV fistula creation with clips

Outcomes

Primary Outcome Measures

Time to loss of primary patency

Secondary Outcome Measures

Time to loss of secondary patency
Time to loss of assisted primary patency
Rate of functional maturation
in patients on dialysis
Time to functional maturation
in patients on dialysis
Rate of assumed maturation
in patients not on dialysis
Time to assumed maturation
in patients not on dialysis
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
Rate of intervention
to maintain patency
Operative cost
Overall cost
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
Time to loss of assisted primary patency
Time to loss of secondary patency

Full Information

First Posted
January 6, 2017
Last Updated
July 3, 2018
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03024372
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study did not get started. Investigator is no longer at this institution
Study Start Date
December 2017 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional sutures
Arm Type
Active Comparator
Arm Description
AV fistula creation with sutures
Arm Title
Anastoclips
Arm Type
Active Comparator
Arm Description
AV fistula creation with clips
Intervention Type
Device
Intervention Name(s)
AV Fistula creation with sutures
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
AV Fistula creation with clips
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to loss of primary patency
Time Frame
one year post surgery
Secondary Outcome Measure Information:
Title
Time to loss of secondary patency
Time Frame
one year post surgery
Title
Time to loss of assisted primary patency
Time Frame
one year post surgery
Title
Rate of functional maturation
Description
in patients on dialysis
Time Frame
one year post surgery
Title
Time to functional maturation
Description
in patients on dialysis
Time Frame
one year post surgery
Title
Rate of assumed maturation
Description
in patients not on dialysis
Time Frame
one year post surgery
Title
Time to assumed maturation
Description
in patients not on dialysis
Time Frame
one year post surgery
Title
Rate of complications
Description
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 Frame
30 days post surgery
Title
Rate of intervention
Description
to maintain patency
Time Frame
five years post surgery
Title
Operative cost
Time Frame
duration of surgery
Title
Overall cost
Description
Overall cost of surgery itself defined as from surgery to point of hospital discharge, anticipated to be in days
Time Frame
time of surgery to time of hospital discharge (can range from 1 day to 1 week or more)
Title
Time to loss of primary patency
Time Frame
5 years post surgery
Title
Time to loss of assisted primary patency
Time Frame
5 years post surgery
Title
Time to loss of secondary patency
Time Frame
5 years post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Illig, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
University of South Florida - South Tampa Campus
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
USF Health Carol and Frank Morsani Center for Advanced Healthcare
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9804495
Citation
Haruguchi H, Nakagawa Y, Uchida Y, Sageshima J, Fuchinoue S, Agishi T. Clinical application of vascular closure staple clips for blood access surgery. ASAIO J. 1998 Sep-Oct;44(5):M562-4. doi: 10.1097/00002480-199809000-00050.
Results Reference
background
PubMed Identifier
11604333
Citation
Schild AF, Pruett CS, Newman MI, Raines J, Petersen F, Konkin T, Kim P, Dickson C, Kirsch WM. The utility of the VCS clip for creation of vascular access for hemodialysis: long-term results and intraoperative benefits. Cardiovasc Surg. 2001 Dec;9(6):526-30. doi: 10.1016/s0967-2109(01)00088-6.
Results Reference
background
PubMed Identifier
11248171
Citation
Cook JW, Schuman ES, Standage BA, Heinl P. Patency and flow characteristics using stapled vascular anastomoses in dialysis grafts. Am J Surg. 2001 Jan;181(1):24-7. doi: 10.1016/s0002-9610(00)00547-x.
Results Reference
background
PubMed Identifier
11221948
Citation
Cooper BZ, Flores L, Ramirez JA, Najjar JG, Abir F, Rayham R, Paladino L, Nguyen M, Panetta TF. Analysis of nonpenetrating clips versus sutures for arterial venous graft anastomosis. Ann Vasc Surg. 2001 Jan;15(1):7-12. doi: 10.1007/s100160010001.
Results Reference
background
PubMed Identifier
15852413
Citation
Zeebregts CJ. Randomized clinical trial of continuous sutures or non-penetrating clips for radiocephalic arteriovenous fistula (Br J Surg 2004; 91: 1438-1442). Br J Surg. 2005 May;92(5):654-5. doi: 10.1002/bjs.5063. No abstract available.
Results Reference
background
PubMed Identifier
8691738
Citation
Sukhatme VP. Vascular access stenosis: prospects for prevention and therapy. Kidney Int. 1996 Apr;49(4):1161-74. doi: 10.1038/ki.1996.167. No abstract available.
Results Reference
background
PubMed Identifier
21772732
Citation
Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.
Results Reference
background
PubMed Identifier
11877717
Citation
Sidawy AN, Gray R, Besarab A, Henry M, Ascher E, Silva M Jr, Miller A, Scher L, Trerotola S, Gregory RT, Rutherford RB, Kent KC. Recommended standards for reports dealing with arteriovenous hemodialysis accesses. J Vasc Surg. 2002 Mar;35(3):603-10. doi: 10.1067/mva.2002.122025.
Results Reference
background
PubMed Identifier
9382393
Citation
Zhou XH, Melfi CA, Hui SL. Methods for comparison of cost data. Ann Intern Med. 1997 Oct 15;127(8 Pt 2):752-6. doi: 10.7326/0003-4819-127-8_part_2-199710151-00063.
Results Reference
background
PubMed Identifier
12891102
Citation
Shenoy S, Miller A, Petersen F, Kirsch WM, Konkin T, Kim P, Dickson C, Schild AF, Stewart L, Reyes M, Anton L, Woodward RS. A multicenter study of permanent hemodialysis access patency: beneficial effect of clipped vascular anastomotic technique. J Vasc Surg. 2003 Aug;38(2):229-35. doi: 10.1016/s0741-5214(03)00412-9.
Results Reference
result
PubMed Identifier
26806237
Citation
Nguyen KP, Teruya T, Alabi O, Sheng N, Bianchi C, Chiriano J, Dehom S, Abou-Zamzam A. Comparison of Nonpenetrating Titanium Clips versus Continuous Polypropylene Suture in Dialysis Access Creation. Ann Vasc Surg. 2016 Apr;32:15-9. doi: 10.1016/j.avsg.2015.11.008. Epub 2016 Jan 22.
Results Reference
result
PubMed Identifier
26506936
Citation
Aitken E, Jeans E, Aitken M, Kingsmore D. A randomized controlled trial of interrupted versus continuous suturing techniques for radiocephalic fistulas. J Vasc Surg. 2015 Dec;62(6):1575-82. doi: 10.1016/j.jvs.2015.07.083. Epub 2015 Oct 23. Erratum In: J Vasc Surg. 2016 Apr;63(4):1133.
Results Reference
result
PubMed Identifier
11531868
Citation
Zeebregts C, van den Dungen J, Buikema H, van der Want J, van Schilfgaarde R. Preservation of endothelial integrity and function in experimental vascular anastomosis with non-penetrating clips. Br J Surg. 2001 Sep;88(9):1201-8. doi: 10.1046/j.0007-1323.2001.01857.x.
Results Reference
result
Links:
URL
https://www.usrds.org
Description
US Renal Data System

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Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

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