<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/NCT01686100</url>
  </required_header>
  <id_info>
    <org_study_id>102841</org_study_id>
    <nct_id>NCT01686100</nct_id>
  </id_info>
  <brief_title>CT-angiographic Follow up of Patients That Underwent Coronary Bypass Surgery Between 1993-1997</brief_title>
  <official_title>CT-angiographic Follow Upp of Patients That Underwent Coronary Bypass Surgery Between 1993-1997. A Randomized Longitudinal Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Örebro County Council</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Örebro County Council</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronary artery surgery (CABG) is necessary to improve blood circulation in many patients&#xD;
      with coronary artery disease. This is done by using alternative blood vessels (grafts) to&#xD;
      bypass the stenosed coronary arteries. In CABG, vein grafts are traditionally used where&#xD;
      surrounding tissue is removed, this may damage the vessel and influence its patency.&#xD;
&#xD;
      The &quot;no-touch&quot; technique was developed by Professor Domingos Souza at the Department of&#xD;
      Cardiovascular and Thoracic Surgery, Örebro University Hospital. This technique includes&#xD;
      taking out the vein with its surrounding tissue and by this way the vessel is less damaged.&#xD;
      The first two follow ups have shown that no-touch grafts had better patency than&#xD;
      conventionally extracted graft at 18 months and 8.5 years.&#xD;
&#xD;
      This long term follow up is a continuation of the randomized trial started in 1993 where the&#xD;
      patency and incidence of stenoses in the no touch and conventional vein grafts has been&#xD;
      studied.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patency of the grafts</measure>
    <time_frame>Mean time of 15 years.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stenosis in the grafts.</measure>
    <time_frame>Mean time of 15 years.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>No touch vein grafts</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The grafts were harvested with there surrounding tissues.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional vein grafts.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The grafts were stripped from surrounding tissue.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No touch technique</intervention_name>
    <description>The vein graft is harvested with its surronding tissues.</description>
    <arm_group_label>No touch vein grafts</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional technique</intervention_name>
    <description>The vein graft is stripped from its surrounding tissues.</description>
    <arm_group_label>Conventional vein grafts.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. First time coronary artery bypass grafting with either conventional or no touch vein&#xD;
             grafts performed by Dr.Souza between 1993-1997.&#xD;
&#xD;
          2. Included in the previous follow up studies&#xD;
&#xD;
          3. Signed and dated consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergy to contrast&#xD;
&#xD;
          2. Renal failure&#xD;
&#xD;
          3. Uncontrolled diabetes&#xD;
&#xD;
          4. Unable to implement the study according to protocol -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department for Cardiovascular and Thoracic Surgery, Örebro University Hospital</name>
      <address>
        <city>Örebro</city>
        <zip>70185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Souza DS, Johansson B, Bojo L, Karlsson R, Geijer H, Filbey D, Bodin L, Arbeus M, Dashwood MR. Harvesting the saphenous vein with surrounding tissue for CABG provides long-term graft patency comparable to the left internal thoracic artery: results of a randomized longitudinal trial. J Thorac Cardiovasc Surg. 2006 Aug;132(2):373-8. doi: 10.1016/j.jtcvs.2006.04.002.</citation>
    <PMID>16872965</PMID>
  </reference>
  <reference>
    <citation>Loesch A, Dashwood MR, Souza DS. Does the method of harvesting the saphenous vein for coronary artery bypass surgery affect venous smooth muscle cells? iNOS immunolabelling and ultrastructural findings. Int J Surg. 2006;4(1):20-9. doi: 10.1016/j.ijsu.2005.11.002. Epub 2006 Jan 3.</citation>
    <PMID>17462310</PMID>
  </reference>
  <reference>
    <citation>Dashwood MR, Dooley A, Shi-Wen X, Abraham DJ, Dreifaldt M, Souza DS. Perivascular fat-derived leptin: a potential role in improved vein graft performance in coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2011 Feb;12(2):170-3. doi: 10.1510/icvts.2010.247874. Epub 2010 Nov 3.</citation>
    <PMID>21051379</PMID>
  </reference>
  <reference>
    <citation>Dreifaldt M, Souza DS, Loesch A, Muddle JR, Karlsson MG, Filbey D, Bodin L, Norgren L, Dashwood MR. The &quot;no-touch&quot; harvesting technique for vein grafts in coronary artery bypass surgery preserves an intact vasa vasorum. J Thorac Cardiovasc Surg. 2011 Jan;141(1):145-50. doi: 10.1016/j.jtcvs.2010.02.005. Epub 2010 Apr 9.</citation>
    <PMID>20381817</PMID>
  </reference>
  <reference>
    <citation>Johansson BL, Souza DS, Bodin L, Filbey D, Loesch A, Geijer H, Bojo L. Slower progression of atherosclerosis in vein grafts harvested with 'no touch' technique compared with conventional harvesting technique in coronary artery bypass grafting: an angiographic and intravascular ultrasound study. Eur J Cardiothorac Surg. 2010 Oct;38(4):414-9. doi: 10.1016/j.ejcts.2010.02.007. Epub 2010 Apr 1.</citation>
    <PMID>20362457</PMID>
  </reference>
  <reference>
    <citation>Johansson BL, Souza DS, Bodin L, Filbey D, Bojo L. No touch vein harvesting technique for CABG improves the long-term clinical outcome. Scand Cardiovasc J. 2009 Feb;43(1):63-8. doi: 10.1080/14017430802140104.</citation>
    <PMID>18609044</PMID>
  </reference>
  <reference>
    <citation>Rueda Fd, Souza D, Lima Rde C, Menezes A, Johansson B, Dashwood M, The E, Gesteira M, Escobar M, Vasconcelos F. Novel no-touch technique of harvesting the saphenous vein for coronary artery bypass grafting. Arq Bras Cardiol. 2008 Jun;90(6):356-62. doi: 10.1590/s0066-782x2008000600002. English, Portuguese.</citation>
    <PMID>18592087</PMID>
  </reference>
  <reference>
    <citation>Dashwood MR, Savage K, Dooley A, Shi-Wen X, Abraham DJ, Souza DS. Effect of vein graft harvesting on endothelial nitric oxide synthase and nitric oxide production. Ann Thorac Surg. 2005 Sep;80(3):939-44. doi: 10.1016/j.athoracsur.2005.03.042.</citation>
    <PMID>16122459</PMID>
  </reference>
  <reference>
    <citation>Dashwood M, Anand R, Loesch A, Souza D. Surgical trauma and vein graft failure: further evidence for a role of ET-1 in graft occlusion. J Cardiovasc Pharmacol. 2004 Nov;44 Suppl 1:S16-9. doi: 10.1097/01.fjc.0000166222.50346.c6.</citation>
    <PMID>15838269</PMID>
  </reference>
  <reference>
    <citation>Souza DS, Dashwood MR, Tsui JC, Filbey D, Bodin L, Johansson B, Borowiec J. Improved patency in vein grafts harvested with surrounding tissue: results of a randomized study using three harvesting techniques. Ann Thorac Surg. 2002 Apr;73(4):1189-95. doi: 10.1016/s0003-4975(02)03425-2.</citation>
    <PMID>11996262</PMID>
  </reference>
  <reference>
    <citation>Tsui JC, Souza DS, Filbey D, Karlsson MG, Dashwood MR. Localization of nitric oxide synthase in saphenous vein grafts harvested with a novel &quot;no-touch&quot; technique: potential role of nitric oxide contribution to improved early graft patency rates. J Vasc Surg. 2002 Feb;35(2):356-62. doi: 10.1067/mva.2002.121072.</citation>
    <PMID>11854735</PMID>
  </reference>
  <reference>
    <citation>Tsui JC, Souza DS, Filbey D, Bomfim V, Dashwood MR. Preserved endothelial integrity and nitric oxide synthase in saphenous vein grafts harvested by a 'no-touch' technique. Br J Surg. 2001 Sep;88(9):1209-15. doi: 10.1046/j.0007-1323.2001.01855.x.</citation>
    <PMID>11531869</PMID>
  </reference>
  <reference>
    <citation>Souza DS, Christofferson RH, Bomfim V, Filbey D. &quot;No-touch&quot; technique using saphenous vein harvested with its surrounding tissue for coronary artery bypass grafting maintains an intact endothelium. Scand Cardiovasc J. 1999;33(6):323-9. doi: 10.1080/14017439950141362.</citation>
    <PMID>10622542</PMID>
  </reference>
  <reference>
    <citation>Souza D. A new no-touch preparation technique. Technical notes. Scand J Thorac Cardiovasc Surg. 1996;30(1):41-4. doi: 10.3109/14017439609107239. No abstract available.</citation>
    <PMID>8727856</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <last_update_submitted>September 18, 2012</last_update_submitted>
  <last_update_submitted_qc>September 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Örebro County Council</investigator_affiliation>
    <investigator_full_name>Ninos Samano M.D.</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Coronary artery bypass grafting</keyword>
  <keyword>Saphenous vein grafts</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01686100
org study id: 102841
nct id: NCT01686100
lead sponsor: 
has dmc: No
Coronary artery surgery (CABG) is necessary to improve blood circulation in many patients
      with coronary artery disease. This is done by using alternative blood vessels (grafts) to
      bypass the stenosed coronary arteries. In CABG, vein grafts are traditionally used where
      surrounding tissue is removed, this may damage the vessel and influence its patency.

      The "no-touch" technique was developed by Professor Domingos Souza at the Department of
      Cardiovascular and Thoracic Surgery, Örebro University Hospital. This technique includes
      taking out the vein with its surrounding tissue and by this way the vessel is less damaged.
      The first two follow ups have shown that no-touch grafts had better patency than
      conventionally extracted graft at 18 months and 8.5 years.

      This long term follow up is a continuation of the randomized trial started in 1993 where the
      patency and incidence of stenoses in the no touch and conventional vein grafts has been
      studied.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Patency of the grafts
time frame: Mean time of 15 years.
measure: Stenosis in the grafts.
time frame: Mean time of 15 years.
arm group label: No touch vein grafts
arm group type: Active Comparator
description: The grafts were harvested with there surrounding tissues.
arm group label: Conventional vein grafts.
arm group type: Active Comparator
description: The grafts were stripped from surrounding tissue.
intervention type: Procedure
intervention name: No touch technique
description: The vein graft is harvested with its surronding tissues.
arm group label: No touch vein grafts
intervention type: Procedure
intervention name: Conventional technique
description: The vein graft is stripped from its surrounding tissues.
arm group label: Conventional vein grafts.
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
citation: Souza DS, Johansson B, Bojo L, Karlsson R, Geijer H, Filbey D, Bodin L, Arbeus M, Dashwood MR. Harvesting the saphenous vein with surrounding tissue for CABG provides long-term graft patency comparable to the left internal thoracic artery: results of a randomized longitudinal trial. J Thorac Cardiovasc Surg. 2006 Aug;132(2):373-8. doi: 10.1016/j.jtcvs.2006.04.002.
PMID: 16872965
citation: Loesch A, Dashwood MR, Souza DS. Does the method of harvesting the saphenous vein for coronary artery bypass surgery affect venous smooth muscle cells? iNOS immunolabelling and ultrastructural findings. Int J Surg. 2006;4(1):20-9. doi: 10.1016/j.ijsu.2005.11.002. Epub 2006 Jan 3.
PMID: 17462310
citation: Dashwood MR, Dooley A, Shi-Wen X, Abraham DJ, Dreifaldt M, Souza DS. Perivascular fat-derived leptin: a potential role in improved vein graft performance in coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2011 Feb;12(2):170-3. doi: 10.1510/icvts.2010.247874. Epub 2010 Nov 3.
PMID: 21051379
citation: Dreifaldt M, Souza DS, Loesch A, Muddle JR, Karlsson MG, Filbey D, Bodin L, Norgren L, Dashwood MR. The "no-touch" harvesting technique for vein grafts in coronary artery bypass surgery preserves an intact vasa vasorum. J Thorac Cardiovasc Surg. 2011 Jan;141(1):145-50. doi: 10.1016/j.jtcvs.2010.02.005. Epub 2010 Apr 9.
PMID: 20381817
citation: Johansson BL, Souza DS, Bodin L, Filbey D, Loesch A, Geijer H, Bojo L. Slower progression of atherosclerosis in vein grafts harvested with 'no touch' technique compared with conventional harvesting technique in coronary artery bypass grafting: an angiographic and intravascular ultrasound study. Eur J Cardiothorac Surg. 2010 Oct;38(4):414-9. doi: 10.1016/j.ejcts.2010.02.007. Epub 2010 Apr 1.
PMID: 20362457
citation: Johansson BL, Souza DS, Bodin L, Filbey D, Bojo L. No touch vein harvesting technique for CABG improves the long-term clinical outcome. Scand Cardiovasc J. 2009 Feb;43(1):63-8. doi: 10.1080/14017430802140104.
PMID: 18609044
citation: Rueda Fd, Souza D, Lima Rde C, Menezes A, Johansson B, Dashwood M, The E, Gesteira M, Escobar M, Vasconcelos F. Novel no-touch technique of harvesting the saphenous vein for coronary artery bypass grafting. Arq Bras Cardiol. 2008 Jun;90(6):356-62. doi: 10.1590/s0066-782x2008000600002. English, Portuguese.
PMID: 18592087
citation: Dashwood MR, Savage K, Dooley A, Shi-Wen X, Abraham DJ, Souza DS. Effect of vein graft harvesting on endothelial nitric oxide synthase and nitric oxide production. Ann Thorac Surg. 2005 Sep;80(3):939-44. doi: 10.1016/j.athoracsur.2005.03.042.
PMID: 16122459
citation: Dashwood M, Anand R, Loesch A, Souza D. Surgical trauma and vein graft failure: further evidence for a role of ET-1 in graft occlusion. J Cardiovasc Pharmacol. 2004 Nov;44 Suppl 1:S16-9. doi: 10.1097/01.fjc.0000166222.50346.c6.
PMID: 15838269
citation: Souza DS, Dashwood MR, Tsui JC, Filbey D, Bodin L, Johansson B, Borowiec J. Improved patency in vein grafts harvested with surrounding tissue: results of a randomized study using three harvesting techniques. Ann Thorac Surg. 2002 Apr;73(4):1189-95. doi: 10.1016/s0003-4975(02)03425-2.
PMID: 11996262
citation: Tsui JC, Souza DS, Filbey D, Karlsson MG, Dashwood MR. Localization of nitric oxide synthase in saphenous vein grafts harvested with a novel "no-touch" technique: potential role of nitric oxide contribution to improved early graft patency rates. J Vasc Surg. 2002 Feb;35(2):356-62. doi: 10.1067/mva.2002.121072.
PMID: 11854735
citation: Tsui JC, Souza DS, Filbey D, Bomfim V, Dashwood MR. Preserved endothelial integrity and nitric oxide synthase in saphenous vein grafts harvested by a 'no-touch' technique. Br J Surg. 2001 Sep;88(9):1209-15. doi: 10.1046/j.0007-1323.2001.01855.x.
PMID: 11531869
citation: Souza DS, Christofferson RH, Bomfim V, Filbey D. "No-touch" technique using saphenous vein harvested with its surrounding tissue for coronary artery bypass grafting maintains an intact endothelium. Scand Cardiovasc J. 1999;33(6):323-9. doi: 10.1080/14017439950141362.
PMID: 10622542
citation: Souza D. A new no-touch preparation technique. Technical notes. Scand J Thorac Cardiovasc Surg. 1996;30(1):41-4. doi: 10.3109/14017439609107239. No abstract available.
PMID: 8727856
responsible party type: Principal Investigator
investigator affiliation: Örebro County Council
investigator full name: Ninos Samano M.D.
investigator title: Doctor
mesh term: Coronary Artery Disease