<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/NCT01669850</url>
  </required_header>
  <id_info>
    <org_study_id>2-12-07-002</org_study_id>
    <nct_id>NCT01669850</nct_id>
  </id_info>
  <brief_title>Clipped Versus Handsewn Arteriovenous Fistula Anastomosis</brief_title>
  <official_title>The Safety and Effectiveness of Clipped Technique vs. Hand-Sewn Technique for Anastomosis in Arteriovenous Fistulas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gundersen Lutheran Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gundersen Lutheran Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gundersen Lutheran Medical Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether handsewn anastomosis versus clipped&#xD;
      technique is associated with more complications, fistula failures, surgical cost and surgical&#xD;
      time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      End stage renal disease requiring hemodialysis has become more prevalent in recent years.&#xD;
      Achieving vascular access is an important step in receiving hemodialysis. Recent national&#xD;
      goals have established that approximately 65% of all dialysis access points should be&#xD;
      arteriovenous fistulas due to higher patency rates and decreased rates of further surgeries.&#xD;
      Multiple studies have been done to assess optimal suture technique for arteriovenous&#xD;
      anastomoses. The use of clips versus a handsewn technique has been evaluated in retrospective&#xD;
      studies with some reports indicating a higher primary patency rate with a clip technique.&#xD;
      Further study is needed to definitively determine the technique that results in the highest&#xD;
      patency rates and lowest rate of re-operation. The purpose of this study is to determine&#xD;
      whether hand-sewn anastomosis versus a clipped technique is associated with more&#xD;
      complications, failures, surgical cost and surgical time by randomizing patients to either a&#xD;
      clipped anastomosis group or a handsewn anastomosis group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    minimal accrual&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Patency rates</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Patency will be assessed and the fistula considered patent if it has been accessed for dialysis at least once, or based on clinical assessment with palpable thrill if dialysis access has not been attempted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical complications</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Complications will be monitored intraoperatively, and postoperatively. These include any re-interventions, and wound complications, infection, hematoma, thrombosis , steal syndrome, distal ischemia.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost</measure>
    <time_frame>1 year postoperative</time_frame>
    <description>Cost for the vascular clip device will be compared to cost of the handsewn technique.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Arteriovenous Fistula Complications and Failure</condition>
  <arm_group>
    <arm_group_label>Clipped anastomosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Handsewn anastomosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Clipped anastomosis</intervention_name>
    <description>The vascular clip devise will be used to complete the anastomosis during fistula creation.</description>
    <arm_group_label>Clipped anastomosis</arm_group_label>
    <other_name>Anastoclip (Le Maitre)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Handsewn anastomosis</intervention_name>
    <description>a handsewn anastomosis technique will be used during fistula creation.</description>
    <arm_group_label>Handsewn anastomosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older.&#xD;
&#xD;
          -  Need for AVF creation for vascular access for planned hemodialysis (within 1 year).&#xD;
&#xD;
          -  The planned AVF site must be naïve of prior AVF creations.&#xD;
&#xD;
          -  Vein mapping studies completed&#xD;
&#xD;
          -  2.5 - 3mm minimum vein diameter on mapping&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years of age.&#xD;
&#xD;
          -  Inability to provide consent.&#xD;
&#xD;
          -  Previous failed AVFs in both arms.&#xD;
&#xD;
          -  Contraindications to AVF creation:&#xD;
&#xD;
               -  ipsilateral proximal venous and arterial occlusion or stenosis&#xD;
&#xD;
               -  systemic or local infection&#xD;
&#xD;
               -  too ill to operate&#xD;
&#xD;
          -  Anticipated inability to keep 30-day postoperative follow-up appointment.&#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>Clark A Davis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gundersen Lutheran Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gundersen Lutheran Health System</name>
      <address>
        <city>La Crosse</city>
        <state>Wisconsin</state>
        <zip>54601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Baguneid MS, Goldner S, Fulford PE, Hamilton G, Walker MG, Seifalian AM. A comparison of para-anastomotic compliance profiles after vascular anastomosis: nonpenetrating clips versus standard sutures. J Vasc Surg. 2001 Apr;33(4):812-20. doi: 10.1067/mva.2001.112806.</citation>
    <PMID>11296337</PMID>
  </reference>
  <reference>
    <citation>Lin PH, Bush RL, Nelson JC, Lam R, Paladugu R, Chen C, Quinn G, Lumsden AB. A prospective evaluation of interrupted nitinol surgical clips in arteriovenous fistula for hemodialysis. Am J Surg. 2003 Dec;186(6):625-30. doi: 10.1016/j.amjsurg.2003.08.007.</citation>
    <PMID>14672769</PMID>
  </reference>
  <reference>
    <citation>Varcoe RL, Teo AB, Pelletier MH, Yu Y, Yang JL, Crowe PJ, Walsh WR. An arteriovenous fistula model of intimal hyperplasia for evaluation of a nitinol U-Clip anastomosis. Eur J Vasc Endovasc Surg. 2012 Feb;43(2):224-31. doi: 10.1016/j.ejvs.2011.11.002. Epub 2011 Nov 21.</citation>
    <PMID>22104322</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Shenoy S, Woodward RS. Economic impact of the beneficial effect of changing vascular anastomotic technique in hemodialysis access. Vasc Endovascular Surg. 2005 Sep-Oct;39(5):437-43. doi: 10.1177/153857440503900509.</citation>
    <PMID>16193217</PMID>
  </reference>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>September 4, 2015</last_update_submitted>
  <last_update_submitted_qc>September 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gundersen Lutheran Medical Foundation</investigator_affiliation>
    <investigator_full_name>Kara Kallies</investigator_full_name>
    <investigator_title>Advanced Research Associate, on behalf of Clark Davis, MD (PI)</investigator_title>
  </responsible_party>
  <keyword>Chronic kidney disease</keyword>
  <keyword>Arteriovenous fistula</keyword>
  <keyword>Surgical anastomosis</keyword>
  <keyword>Complications</keyword>
  <keyword>Patency</keyword>
  <keyword>Dialysis access</keyword>
  <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>
  <pending_results>
    <submitted>February 22, 2019</submitted>
    <returned>March 18, 2019</returned>
  </pending_results>
  <!-- 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/NCT01669850
org study id: 2-12-07-002
nct id: NCT01669850
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether handsewn anastomosis versus clipped
      technique is associated with more complications, fistula failures, surgical cost and surgical
      time.
End stage renal disease requiring hemodialysis has become more prevalent in recent years.
      Achieving vascular access is an important step in receiving hemodialysis. Recent national
      goals have established that approximately 65% of all dialysis access points should be
      arteriovenous fistulas due to higher patency rates and decreased rates of further surgeries.
      Multiple studies have been done to assess optimal suture technique for arteriovenous
      anastomoses. The use of clips versus a handsewn technique has been evaluated in retrospective
      studies with some reports indicating a higher primary patency rate with a clip technique.
      Further study is needed to definitively determine the technique that results in the highest
      patency rates and lowest rate of re-operation. The purpose of this study is to determine
      whether hand-sewn anastomosis versus a clipped technique is associated with more
      complications, failures, surgical cost and surgical time by randomizing patients to either a
      clipped anastomosis group or a handsewn anastomosis group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Patency rates
time frame: 2 years postoperative
description: Patency will be assessed and the fistula considered patent if it has been accessed for dialysis at least once, or based on clinical assessment with palpable thrill if dialysis access has not been attempted.
measure: Surgical complications
time frame: 2 years postoperative
description: Complications will be monitored intraoperatively, and postoperatively. These include any re-interventions, and wound complications, infection, hematoma, thrombosis , steal syndrome, distal ischemia.
measure: Cost
time frame: 1 year postoperative
description: Cost for the vascular clip device will be compared to cost of the handsewn technique.
arm group label: Clipped anastomosis
arm group type: Experimental
description: A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation.
arm group label: Handsewn anastomosis
arm group type: Active Comparator
description: A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation.
intervention type: Device
intervention name: Clipped anastomosis
description: The vascular clip devise will be used to complete the anastomosis during fistula creation.
arm group label: Clipped anastomosis
other name: Anastoclip (Le Maitre)
intervention type: Procedure
intervention name: Handsewn anastomosis
description: a handsewn anastomosis technique will be used during fistula creation.
arm group label: Handsewn anastomosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clark A Davis, MD
role: Principal Investigator
affiliation: Gundersen Lutheran Health System
facility: 
country: United States
citation: Baguneid MS, Goldner S, Fulford PE, Hamilton G, Walker MG, Seifalian AM. A comparison of para-anastomotic compliance profiles after vascular anastomosis: nonpenetrating clips versus standard sutures. J Vasc Surg. 2001 Apr;33(4):812-20. doi: 10.1067/mva.2001.112806.
PMID: 11296337
citation: Lin PH, Bush RL, Nelson JC, Lam R, Paladugu R, Chen C, Quinn G, Lumsden AB. A prospective evaluation of interrupted nitinol surgical clips in arteriovenous fistula for hemodialysis. Am J Surg. 2003 Dec;186(6):625-30. doi: 10.1016/j.amjsurg.2003.08.007.
PMID: 14672769
citation: Varcoe RL, Teo AB, Pelletier MH, Yu Y, Yang JL, Crowe PJ, Walsh WR. An arteriovenous fistula model of intimal hyperplasia for evaluation of a nitinol U-Clip anastomosis. Eur J Vasc Endovasc Surg. 2012 Feb;43(2):224-31. doi: 10.1016/j.ejvs.2011.11.002. Epub 2011 Nov 21.
PMID: 22104322
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: Shenoy S, Woodward RS. Economic impact of the beneficial effect of changing vascular anastomotic technique in hemodialysis access. Vasc Endovascular Surg. 2005 Sep-Oct;39(5):437-43. doi: 10.1177/153857440503900509.
PMID: 16193217
responsible party type: Principal Investigator
investigator affiliation: Gundersen Lutheran Medical Foundation
investigator full name: Kara Kallies
investigator title: Advanced Research Associate, on behalf of Clark Davis, MD (PI)
mesh term: Arteriovenous Fistula
mesh term: Fistula
submitted: February 22, 2019
returned: March 18, 2019