<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03024372</url>
  </required_header>
  <id_info>
    <org_study_id>Sutures vs Clips AVF</org_study_id>
    <nct_id>NCT03024372</nct_id>
  </id_info>
  <brief_title>Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation</brief_title>
  <official_title>A Prospective Randomized Single Blinded Study of Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of South Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate a promising strategy to improve maturation and&#xD;
      patency rates following creation of AV fistulas and assess whether an anastomosis performed&#xD;
      with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency&#xD;
      than one performed with conventional suturing techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single blind (patient and dialysis center), prospective, randomized trial&#xD;
      conducted at a single center. The study intervention will be randomization between&#xD;
      conventional sutured anastomosis (Control group) and use of Anastoclips (Treatment group),&#xD;
      which provide an interrupted closure without intimal penetration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study did not get started. Investigator is no longer at this institution&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2017</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to loss of primary patency</measure>
    <time_frame>one year post surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to loss of secondary patency</measure>
    <time_frame>one year post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to loss of assisted primary patency</measure>
    <time_frame>one year post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of functional maturation</measure>
    <time_frame>one year post surgery</time_frame>
    <description>in patients on dialysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to functional maturation</measure>
    <time_frame>one year post surgery</time_frame>
    <description>in patients on dialysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of assumed maturation</measure>
    <time_frame>one year post surgery</time_frame>
    <description>in patients not on dialysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to assumed maturation</measure>
    <time_frame>one year post surgery</time_frame>
    <description>in patients not on dialysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of complications</measure>
    <time_frame>30 days post surgery</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of intervention</measure>
    <time_frame>five years post surgery</time_frame>
    <description>to maintain patency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative cost</measure>
    <time_frame>duration of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall cost</measure>
    <time_frame>time of surgery to time of hospital discharge (can range from 1 day to 1 week or more)</time_frame>
    <description>Overall cost of surgery itself defined as from surgery to point of hospital discharge, anticipated to be in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to loss of primary patency</measure>
    <time_frame>5 years post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to loss of assisted primary patency</measure>
    <time_frame>5 years post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to loss of secondary patency</measure>
    <time_frame>5 years post surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Arteriovenous Fistula</condition>
  <arm_group>
    <arm_group_label>Conventional sutures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>AV fistula creation with sutures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anastoclips</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>AV fistula creation with clips</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AV Fistula creation with sutures</intervention_name>
    <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.</description>
    <arm_group_label>Conventional sutures</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AV Fistula creation with clips</intervention_name>
    <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.</description>
    <arm_group_label>Anastoclips</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Requiring brachiocephalic fistula judged to be best option for access after vein&#xD;
             mapping (Surgeons will be required to do 10 cases using Anastoclips prior to&#xD;
             enrolling)&#xD;
&#xD;
          -  Able to provide informed consent in English or Spanish&#xD;
&#xD;
          -  Age 18 years or greater&#xD;
&#xD;
          -  With estimated life expectancy of 2 years or more&#xD;
&#xD;
          -  Able to comply with study procedures including all scheduled follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent in English or Spanish&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  With pacemaker, IACD, or other permanent obstructive device on that side (a temporary&#xD;
             tunneled dialysis catheter is not an exclusion)&#xD;
&#xD;
          -  Unable (or in surgeon's judgment a poor risk) to comply with study procedures and&#xD;
             follow-up visits&#xD;
&#xD;
          -  With estimated life expectancy of less than 2 years&#xD;
&#xD;
          -  Females must be either:&#xD;
&#xD;
               -  Of non-childbearing potential, which is defined as post-menopausal (at least 12&#xD;
                  months without menses prior to Treatment Day) or documented surgically sterile or&#xD;
                  post hysterectomy (at least 1 month prior to Treatment Day)&#xD;
&#xD;
               -  Or, of childbearing potential, in which case must have a negative urine pregnancy&#xD;
                  test at Treatment Day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karl Illig, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida - South Tampa Campus</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USF Health Carol and Frank Morsani Center for Advanced Healthcare</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.usrds.org</url>
    <description>US Renal Data System</description>
  </link>
  <reference>
    <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.</citation>
    <PMID>9804495</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11604333</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11248171</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11221948</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>15852413</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>8691738</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21772732</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11877717</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>9382393</PMID>
  </reference>
  <results_reference>
    <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.</citation>
    <PMID>12891102</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>26806237</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>26506936</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>11531868</PMID>
  </results_reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>July 3, 2018</last_update_submitted>
  <last_update_submitted_qc>July 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arteriovenous Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03024372
org study id: Sutures vs Clips AVF
nct id: NCT03024372
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Time to loss of primary patency
time frame: one year post surgery
measure: Time to loss of secondary patency
time frame: one year post surgery
measure: Time to loss of assisted primary patency
time frame: one year post surgery
measure: Rate of functional maturation
time frame: one year post surgery
description: in patients on dialysis
measure: Time to functional maturation
time frame: one year post surgery
description: in patients on dialysis
measure: Rate of assumed maturation
time frame: one year post surgery
description: in patients not on dialysis
measure: Time to assumed maturation
time frame: one year post surgery
description: in patients not on dialysis
measure: Rate of complications
time frame: 30 days post surgery
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
measure: Rate of intervention
time frame: five years post surgery
description: to maintain patency
measure: Operative cost
time frame: duration of surgery
measure: Overall cost
time frame: time of surgery to time of hospital discharge (can range from 1 day to 1 week or more)
description: Overall cost of surgery itself defined as from surgery to point of hospital discharge, anticipated to be in days
measure: Time to loss of primary patency
time frame: 5 years post surgery
measure: Time to loss of assisted primary patency
time frame: 5 years post surgery
measure: Time to loss of secondary patency
time frame: 5 years post surgery
arm group label: Conventional sutures
arm group type: Active Comparator
description: AV fistula creation with sutures
arm group label: Anastoclips
arm group type: Active Comparator
description: AV fistula creation with clips
intervention type: Device
intervention name: AV Fistula creation with sutures
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.
arm group label: Conventional sutures
intervention type: Device
intervention name: AV Fistula creation with clips
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.
arm group label: Anastoclips
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karl Illig, MD
role: Principal Investigator
affiliation: University of South Florida
facility: 
facility: 
facility: 
country: United States
url: https://www.usrds.org
description: US Renal Data System
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.
PMID: 9804495
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.
PMID: 11604333
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.
PMID: 11248171
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.
PMID: 11221948
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.
PMID: 15852413
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.
PMID: 8691738
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.
PMID: 21772732
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.
PMID: 11877717
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.
PMID: 9382393
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.
PMID: 12891102
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.
PMID: 26806237
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.
PMID: 26506936
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.
PMID: 11531868
responsible party type: Sponsor
mesh term: Arteriovenous Fistula
mesh term: Fistula
sharing ipd: No