<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/NCT03805048</url>
  </required_header>
  <id_info>
    <org_study_id>Amsterdam UMC</org_study_id>
    <nct_id>NCT03805048</nct_id>
  </id_info>
  <brief_title>PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior CABG</brief_title>
  <acronym>PROCTOR</acronym>
  <official_title>PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior cORonary Artery Bypass Graft Surgery - the PROCTOR Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amsterdam UMC, location VUmc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multi-centre, randomised clinical trial with anticipated 17 European centres: in the&#xD;
      Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a&#xD;
      clinical indication for revascularization will be randomized to either PCI of the native&#xD;
      vessel or PCI of the dysfunctional venous bypass graft. 584 patients with a a clinical&#xD;
      indication for percutaneous coronary intervention and a dysfunctional graft on the target&#xD;
      vesselional venous bypass graft are planned to be enrolled during 3 years.Study objectives:&#xD;
      to investigate the clinical and angiographic outcome of native vessel PCI compared to PCI of&#xD;
      venous bypass graft in patients with a dysfunctional venous bypass graft with a clinical&#xD;
      indication for revascularization. 1 year and 5 years, follow-up will be performed by means of&#xD;
      a telephonic visit. After 3 years patients will be admitted to undergo a control invasive&#xD;
      angiography.The CT-substudy and the PROCTOR registry is planned to be conducted too.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multi-centre, randomised clinical trial with anticipated 17 European centres: in the&#xD;
      Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a&#xD;
      clinical indication for revascularization will be randomized to either PCI of the native&#xD;
      vessel or PCI of the dysfunctional venous bypass graft. The CT-substudy and the PROCTOR&#xD;
      registry is planned to be conducted too (details included in the flow chart).&#xD;
&#xD;
      CCTA substudy Selected patients will be approached for participation in the CCTA substudy of&#xD;
      the trial. Participation in this substudy is optional. After written informed consent is&#xD;
      obtained patients will undergo a CCTA in an out-patient setting. The CCTA will be performed&#xD;
      before the PCI procedure.&#xD;
&#xD;
      PROCTOR registry&#xD;
&#xD;
      Patients can be approached for the registry when :&#xD;
&#xD;
        -  PCI have been deemed clinically indicated by the local hartteam, and&#xD;
&#xD;
        -  both the lesions in the native vessel and the dysfunctional graft have been deemed&#xD;
           technically feasible by the local hartteam,&#xD;
&#xD;
        -  the patient does not meet the in- and exclusion criteria for the randomized PROCTOR&#xD;
           study or declines to participate in the randomized study.&#xD;
&#xD;
      Patients will be approached for participation and will have one week to consider. Written&#xD;
      informed consent is mandatory for participating in the registry. Patients will be followed by&#xD;
      telephonic follow-up after 1, 3, and 5 years. No additional study procedures will be&#xD;
      performed.&#xD;
&#xD;
      Study objectives:to investigate the clinical and angiographic outcome of native vessel PCI&#xD;
      compared to PCI of venous bypass graft in patients with a dysfunctional venous bypass graft&#xD;
      with a clinical indication for revascularization.&#xD;
&#xD;
        1. PROCTOR main study&#xD;
&#xD;
           - Investigate the clinical outcome of native vessel PCI vs. PCI of dysfunctional venous&#xD;
           bypass graft with a clinical indication for revascularisation&#xD;
&#xD;
        2. CCTA substudy&#xD;
&#xD;
             -  Investigate prognostic value of CT-derived plaque characteristics for occurrence of&#xD;
                MACE following bypass graft PCI&#xD;
&#xD;
             -  Investigate value of CCTA in guidance of CTO PCI procedures&#xD;
&#xD;
        3. PROCTOR Registry - Investigate long-term clinical outcomes in patients with&#xD;
           dysfunctional venous bypass graft and an indication for PCI whom are not included in&#xD;
           randomised main study.&#xD;
&#xD;
      All patients with a significant stenosis (&gt;50% on coronary angiography) in a venous bypass&#xD;
      graft discussed in the local heart team for revascularization will be screened for potential&#xD;
      inclusion in the study. Patients will be eligible for inclusion if revascularization is&#xD;
      deemed clinically indicated and technically feasible for PCI by the local heart team. The&#xD;
      indication for revascularization will be based on symptoms and evidence of ischemia and&#xD;
      viability in the target vessel territory. The lesion in the native vessel must be bypassed by&#xD;
      a single venous graft or must be connected to a jump graft at the most distal anastomosis of&#xD;
      that graft. In jump grafts, the lesion must be located distally to the second-to-last&#xD;
      anastomosis. In case both the lesion in the native vessel and the lesion in the graft are&#xD;
      deemed technically feasible for PCI, patients will be eligible for inclusion in the&#xD;
      randomized study after consideration of in- and exclusion criteria. Patients who do not meet&#xD;
      these criteria or decline to participate in the randomized study will be approached for&#xD;
      inclusion in the registry. Subsequently patients will be approached for study participation.&#xD;
      After being informed, patients will have at least 24 hours to consider participation. An&#xD;
      independent physician will be available for extra information, if desired. After obtaining&#xD;
      written informed consent, patients will be randomized to either native vessel PCI or PCI of&#xD;
      the venous bypass graft. In case of PCI failure, a second attempt can be performed by the&#xD;
      operator within one month.&#xD;
&#xD;
      If feasible, it is possible to perform a second attempt in another high-volume center. When&#xD;
      successful PCI cannot be accomplished in one or two attempts, cross-over to the other&#xD;
      treatment arm may be used as bailout strategy to restore myocardial blood flow to the distal&#xD;
      vascular bed of the vessel. Randomization will be performed using an interactive Web-based&#xD;
      randomization system, Open Clinica. After 1 and 5 years, follow-up will be performed by means&#xD;
      of a telephonic visit. After 3 years patients will be admitted to undergo a control invasive&#xD;
      angiography.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2026</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>
    <intervention_model_description>Patients will be randomized to either native vessel PCI or PCI of the venous bypass graft in a 1:1 fashion. Randomization will be performed using an interactive Web-based randomization system, Open Clinica</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount and type of Major Adverse Cardiac Events</measure>
    <time_frame>3 year follow up</time_frame>
    <description>The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven target lesion revascularization).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amount and type of Major Adverse Cardiac Events</measure>
    <time_frame>1 and 5 year follow-up</time_frame>
    <description>The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven target lesion revascularization).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of patients that have passed away</measure>
    <time_frame>1, 3 and 5 year follow-up</time_frame>
    <description>Mortality score, all-cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of non-fatal myocardial infarctions</measure>
    <time_frame>1, 3 and 5 year follow-up</time_frame>
    <description>Any non-fatal myocardial infarction noticed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically driven target lesion revascularizations</measure>
    <time_frame>1, 3 and 5 year follow-up</time_frame>
    <description>Any clinically driven target lesion revascularization noticed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of target vessel revascularizations</measure>
    <time_frame>1, 3 and 5 year follow-up</time_frame>
    <description>Any target vessel revascularization noticed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of target vessel failure.</measure>
    <time_frame>1, 3 and 5 year follow-up</time_frame>
    <description>Any target vessel failure noticed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of non-fatal myocardial infarctions.</measure>
    <time_frame>&gt;48 hours after PCI</time_frame>
    <description>Any non-fatal myocardial infarction noticed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of PCI-related myocardial infarctions.</measure>
    <time_frame>1, 3 and 5 year follow-up</time_frame>
    <description>Any PCI-related myocardial infarction noticed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specific angiographic outcome</measure>
    <time_frame>3-year follow up</time_frame>
    <description>Any of the following outcomes:&#xD;
Late lumen loss&#xD;
In-stent binary restenosis (≥50%)&#xD;
In-stent re-occlusion&#xD;
Difference in in-stent diameter stenosis between index procedure at inclusion, and at 3-year follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by SAQ</measure>
    <time_frame>1, 3 and 5 year follow-up</time_frame>
    <description>The Seattle Angina Questionnaire is a self-assessment questionnaire where patients' physical limitations caused by angina are quantified, as well as the frequency of and changes in their symptoms, their satisfaction with treatment and how they perceive their Quality of Life. Each scale is transformed to a 0-100 scale. the higher the score, the better the patients functions/the higher the Quality of Life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by CCS</measure>
    <time_frame>1, 3 and 5 year follow-up</time_frame>
    <description>Canadian Cardiovascular Society (CCS) Grading Scale measures whether patient have angina pectoris complaints, and to what extent patients experienced this. It uses a scale of 1-4 where 1 means angina pectoris (chest pain) only occurs with streneous, rapid or prolonged exertion, and 4 means angina is present during little physical effort or even during rest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by RDS</measure>
    <time_frame>1, 3 and 5 year follow-up</time_frame>
    <description>Rose dyspnea scale questionnaire (RDS) measures dyspnea complaints, or shortness of breath. It consists of 4 questions about dysnpea complaints in the everyday life of patients. For every patient, a score is compiled of the highest limitation in daily life, resulting in a score of 0-4, where 0 means no dyspnea complaints and 4 means the patient has complaints during no or minimal physical effort.&#xD;
The scores from these questionnaires will be combined by summing the total scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite score of quality of life</measure>
    <time_frame>3-year follow-up</time_frame>
    <description>Composite of all quality of life questionnaires, where all outcomes are summed to provide a total score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">584</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Native Vessel PCI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients with a significant stenosis (&gt;50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Percutaneous coronary intervention of the native vessel will be performed according to current standard. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using four complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation and retrograde dissection reentry.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Graft PCI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients with a significant stenosis (&gt;50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Percutaneous coronary intervention of the bypass graft will be performed following current standards and at the discretion of the operating interventional cardiologist. Only commercially available second generation DES will be used in the treatment of bypass grafts. The second generation DES used in this study will be the XIENCE Sierra stent. The use of a filter-wire during the procedure will be left at the discretion of the operator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous coronary intervention</intervention_name>
    <description>PCI of the bypass graft will be performed by current standards and at the discretion of the operator. Only commercially available second generation DES - XIENCE Sierra will be used. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using 4 complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation, retrograde dissection reentry. In case of PCI failure, a second attempt can be performed within 1 month. Patients will be hospitalized for a min. of 6-8 hours after PCI and receive DAPT prior to the procedure or triple therapy in case of indication for oral anticoagulation, their duration according to the current guidelines of the ESC for stable coronary disease or ACS.</description>
    <arm_group_label>Graft PCI</arm_group_label>
    <arm_group_label>Native Vessel PCI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A significant stenosis (&gt;50% on angiography) in a venous bypass graft&#xD;
&#xD;
               -  The native lesion must be bypassed by a single graft or must be connected to a&#xD;
                  jump graft at the most distal anastomosis of that graft&#xD;
&#xD;
               -  In jumpgraft lesions, the lesion must be located distally to the second-to-last&#xD;
                  anastomosis&#xD;
&#xD;
          -  Clinical indication for revascularization as determined by the local heart team (based&#xD;
             on symptoms, documented ischemia, and viability).&#xD;
&#xD;
          -  Both the native lesion and the venous graft lesion must be deemed suitable for PCI&#xD;
             with a commercially available second generation DES.&#xD;
&#xD;
          -  Informed consent must be obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
&#xD;
          -  Target vessel diameter &lt; 2.5 mm&#xD;
&#xD;
          -  CABG performed less than 1 year prior to inclusion&#xD;
&#xD;
          -  Diameter of the graft &gt; 5.5 mm&#xD;
&#xD;
          -  Aneurysm formation in the bypass graft&#xD;
&#xD;
          -  Heavy burden of thrombus in the bypass graft (&gt;50% of the bypass graft lumen in ≥2 out&#xD;
             of 3 of the proximal, middle or distal third of the bypass graft).&#xD;
&#xD;
          -  STEMI at presentation&#xD;
&#xD;
          -  NSTEMI patients with ongoing ischemia&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Severe kidney disease defined as an eGFR &lt; 30 ml/min.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Estimated life expectancy &lt; 3 year&#xD;
&#xD;
          -  Contraindications to PCI&#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>Paul Knaapen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paul Knaapen, Prof</last_name>
    <phone>+31 20 4440123</phone>
    <email>p.knaapen@amsterdamumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Iris Vegting</last_name>
    <phone>+31 20 4444445</phone>
    <email>i.vegting1@amsterdamumc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Antwerp</city>
        <state>Edegem</state>
        <zip>B 2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steven Haine, MD, PhD</last_name>
    </contact>
    <contact_backup>
      <last_name>Nathalie Brosens</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim</name>
      <address>
        <city>Antwerpen</city>
        <zip>2020</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierfrancesco Agostoni, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg</name>
      <address>
        <city>Genk</city>
        <zip>B-3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jo Dens, MD, PhD</last_name>
    </contact>
    <contact_backup>
      <last_name>Caroline Swijsen</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johan Bennett, Prof</last_name>
    </contact>
    <contact_backup>
      <last_name>Sabine Van Roey</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Universitäts Herzzentrum</name>
      <address>
        <city>Bad Krozingen</city>
        <zip>79189</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kambis Mashayekhi, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Stefanie Kittler</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Universitair Medische Centra</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paul Knaapen, MD, PhD</last_name>
    </contact>
    <contact_backup>
      <last_name>Iris Vegting</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>José Henriques, Prof.</last_name>
    </contact>
    <contact_backup>
      <last_name>Anna Van Veelen</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Amphia Ziekenhuis</name>
      <address>
        <city>Breda</city>
        <zip>4818 CK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bas Schölzel, MD, PhD</last_name>
    </contact>
    <contact_backup>
      <last_name>Saskia van Roij</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Koen Teeuwen, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Esther van Dooren</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <zip>8934</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sjoerd Hofma, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sint Antonius Ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3435</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan-Peter van Kuijk, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Radboud Universitair Medisch Centrum (Radboud UMC)</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Jan van Geuns, Prof.</last_name>
    </contact>
    <contact_backup>
      <last_name>Sophie Bogaerts</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adriaan Kraaijeveld, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Carmita Junger</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Kardiologii Stefana Kardynała Wyszyńskiego Państwowy Instytut Badawczy</name>
      <address>
        <city>Warsaw</city>
        <zip>04-628</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maksymilian Opolski, MD PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Basildon &amp; Thurrock University Hospitals (Essex CTC)</name>
      <address>
        <city>Basildon</city>
        <zip>SS16 5NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>John Davies, MD, PhDss</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Health and Social Care Trust</name>
      <address>
        <city>Belfast</city>
        <zip>BT8 8BH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Simon Walsh, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Royal Bournemouth &amp; Christchurch Hospitals NHS Foundation Trust</name>
      <address>
        <city>Bournemouth</city>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Peter O'Kane, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>UH Bristol NHS Trust, Bristol Heart Institute</name>
      <address>
        <city>Bristol</city>
        <zip>BS1 3NU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Julian Strange, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Golden Jubilee National Hospital</name>
      <address>
        <city>Glasgow</city>
        <zip>G81 4HX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Margaret Mc Entegart, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St George's University Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Spratt, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Manchester University NHS Foundation Trust, Wythenshawe Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Saqib Chowdhary, MD,PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>September 13, 2021</last_update_submitted>
  <last_update_submitted_qc>September 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Amsterdam UMC, location VUmc</investigator_affiliation>
    <investigator_full_name>Paul Knaapen</investigator_full_name>
    <investigator_title>Prinicipal Investigator</investigator_title>
  </responsible_party>
  <keyword>Percutaneous Coronary Intervention</keyword>
  <keyword>Dysfunctional venous bypass graft</keyword>
  <keyword>Second generation DES</keyword>
  <keyword>CABG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03805048
org study id: Amsterdam UMC
nct id: NCT03805048
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Multi-centre, randomised clinical trial with anticipated 17 European centres: in the
      Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a
      clinical indication for revascularization will be randomized to either PCI of the native
      vessel or PCI of the dysfunctional venous bypass graft. 584 patients with a a clinical
      indication for percutaneous coronary intervention and a dysfunctional graft on the target
      vesselional venous bypass graft are planned to be enrolled during 3 years.Study objectives:
      to investigate the clinical and angiographic outcome of native vessel PCI compared to PCI of
      venous bypass graft in patients with a dysfunctional venous bypass graft with a clinical
      indication for revascularization. 1 year and 5 years, follow-up will be performed by means of
      a telephonic visit. After 3 years patients will be admitted to undergo a control invasive
      angiography.The CT-substudy and the PROCTOR registry is planned to be conducted too.
Multi-centre, randomised clinical trial with anticipated 17 European centres: in the
      Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a
      clinical indication for revascularization will be randomized to either PCI of the native
      vessel or PCI of the dysfunctional venous bypass graft. The CT-substudy and the PROCTOR
      registry is planned to be conducted too (details included in the flow chart).

      CCTA substudy Selected patients will be approached for participation in the CCTA substudy of
      the trial. Participation in this substudy is optional. After written informed consent is
      obtained patients will undergo a CCTA in an out-patient setting. The CCTA will be performed
      before the PCI procedure.

      PROCTOR registry

      Patients can be approached for the registry when :

        -  PCI have been deemed clinically indicated by the local hartteam, and

        -  both the lesions in the native vessel and the dysfunctional graft have been deemed
           technically feasible by the local hartteam,

        -  the patient does not meet the in- and exclusion criteria for the randomized PROCTOR
           study or declines to participate in the randomized study.

      Patients will be approached for participation and will have one week to consider. Written
      informed consent is mandatory for participating in the registry. Patients will be followed by
      telephonic follow-up after 1, 3, and 5 years. No additional study procedures will be
      performed.

      Study objectives:to investigate the clinical and angiographic outcome of native vessel PCI
      compared to PCI of venous bypass graft in patients with a dysfunctional venous bypass graft
      with a clinical indication for revascularization.

        1. PROCTOR main study

           - Investigate the clinical outcome of native vessel PCI vs. PCI of dysfunctional venous
           bypass graft with a clinical indication for revascularisation

        2. CCTA substudy

             -  Investigate prognostic value of CT-derived plaque characteristics for occurrence of
                MACE following bypass graft PCI

             -  Investigate value of CCTA in guidance of CTO PCI procedures

        3. PROCTOR Registry - Investigate long-term clinical outcomes in patients with
           dysfunctional venous bypass graft and an indication for PCI whom are not included in
           randomised main study.

      All patients with a significant stenosis (>50% on coronary angiography) in a venous bypass
      graft discussed in the local heart team for revascularization will be screened for potential
      inclusion in the study. Patients will be eligible for inclusion if revascularization is
      deemed clinically indicated and technically feasible for PCI by the local heart team. The
      indication for revascularization will be based on symptoms and evidence of ischemia and
      viability in the target vessel territory. The lesion in the native vessel must be bypassed by
      a single venous graft or must be connected to a jump graft at the most distal anastomosis of
      that graft. In jump grafts, the lesion must be located distally to the second-to-last
      anastomosis. In case both the lesion in the native vessel and the lesion in the graft are
      deemed technically feasible for PCI, patients will be eligible for inclusion in the
      randomized study after consideration of in- and exclusion criteria. Patients who do not meet
      these criteria or decline to participate in the randomized study will be approached for
      inclusion in the registry. Subsequently patients will be approached for study participation.
      After being informed, patients will have at least 24 hours to consider participation. An
      independent physician will be available for extra information, if desired. After obtaining
      written informed consent, patients will be randomized to either native vessel PCI or PCI of
      the venous bypass graft. In case of PCI failure, a second attempt can be performed by the
      operator within one month.

      If feasible, it is possible to perform a second attempt in another high-volume center. When
      successful PCI cannot be accomplished in one or two attempts, cross-over to the other
      treatment arm may be used as bailout strategy to restore myocardial blood flow to the distal
      vascular bed of the vessel. Randomization will be performed using an interactive Web-based
      randomization system, Open Clinica. After 1 and 5 years, follow-up will be performed by means
      of a telephonic visit. After 3 years patients will be admitted to undergo a control invasive
      angiography.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized to either native vessel PCI or PCI of the venous bypass graft in a 1:1 fashion. Randomization will be performed using an interactive Web-based randomization system, Open Clinica
primary purpose: Treatment
masking: Single (Participant)
measure: Amount and type of Major Adverse Cardiac Events
time frame: 3 year follow up
description: The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven target lesion revascularization).
measure: Amount and type of Major Adverse Cardiac Events
time frame: 1 and 5 year follow-up
description: The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven target lesion revascularization).
measure: Amount of patients that have passed away
time frame: 1, 3 and 5 year follow-up
description: Mortality score, all-cause mortality
measure: Number of non-fatal myocardial infarctions
time frame: 1, 3 and 5 year follow-up
description: Any non-fatal myocardial infarction noticed
measure: Number of clinically driven target lesion revascularizations
time frame: 1, 3 and 5 year follow-up
description: Any clinically driven target lesion revascularization noticed
measure: Number of target vessel revascularizations
time frame: 1, 3 and 5 year follow-up
description: Any target vessel revascularization noticed.
measure: Number of target vessel failure.
time frame: 1, 3 and 5 year follow-up
description: Any target vessel failure noticed
measure: Number of non-fatal myocardial infarctions.
time frame: >48 hours after PCI
description: Any non-fatal myocardial infarction noticed.
measure: Number of PCI-related myocardial infarctions.
time frame: 1, 3 and 5 year follow-up
description: Any PCI-related myocardial infarction noticed.
measure: Specific angiographic outcome
time frame: 3-year follow up
description: Any of the following outcomes:
Late lumen loss
In-stent binary restenosis (≥50%)
In-stent re-occlusion
Difference in in-stent diameter stenosis between index procedure at inclusion, and at 3-year follow-up
measure: Quality of life assessed by SAQ
time frame: 1, 3 and 5 year follow-up
description: The Seattle Angina Questionnaire is a self-assessment questionnaire where patients' physical limitations caused by angina are quantified, as well as the frequency of and changes in their symptoms, their satisfaction with treatment and how they perceive their Quality of Life. Each scale is transformed to a 0-100 scale. the higher the score, the better the patients functions/the higher the Quality of Life.
measure: Quality of life assessed by CCS
time frame: 1, 3 and 5 year follow-up
description: Canadian Cardiovascular Society (CCS) Grading Scale measures whether patient have angina pectoris complaints, and to what extent patients experienced this. It uses a scale of 1-4 where 1 means angina pectoris (chest pain) only occurs with streneous, rapid or prolonged exertion, and 4 means angina is present during little physical effort or even during rest.
measure: Quality of life assessed by RDS
time frame: 1, 3 and 5 year follow-up
description: Rose dyspnea scale questionnaire (RDS) measures dyspnea complaints, or shortness of breath. It consists of 4 questions about dysnpea complaints in the everyday life of patients. For every patient, a score is compiled of the highest limitation in daily life, resulting in a score of 0-4, where 0 means no dyspnea complaints and 4 means the patient has complaints during no or minimal physical effort.
The scores from these questionnaires will be combined by summing the total scores.
measure: Composite score of quality of life
time frame: 3-year follow-up
description: Composite of all quality of life questionnaires, where all outcomes are summed to provide a total score
arm group label: Native Vessel PCI
arm group type: Other
description: All patients with a significant stenosis (>50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Percutaneous coronary intervention of the native vessel will be performed according to current standard. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using four complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation and retrograde dissection reentry.
arm group label: Graft PCI
arm group type: Other
description: All patients with a significant stenosis (>50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Percutaneous coronary intervention of the bypass graft will be performed following current standards and at the discretion of the operating interventional cardiologist. Only commercially available second generation DES will be used in the treatment of bypass grafts. The second generation DES used in this study will be the XIENCE Sierra stent. The use of a filter-wire during the procedure will be left at the discretion of the operator.
intervention type: Procedure
intervention name: Percutaneous coronary intervention
description: PCI of the bypass graft will be performed by current standards and at the discretion of the operator. Only commercially available second generation DES - XIENCE Sierra will be used. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using 4 complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation, retrograde dissection reentry. In case of PCI failure, a second attempt can be performed within 1 month. Patients will be hospitalized for a min. of 6-8 hours after PCI and receive DAPT prior to the procedure or triple therapy in case of indication for oral anticoagulation, their duration according to the current guidelines of the ESC for stable coronary disease or ACS.
arm group label: Graft PCI
arm group label: Native Vessel PCI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Knaapen
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
last name: Paul Knaapen, Prof
phone: +31 20 4440123
email: p.knaapen@amsterdamumc.nl
last name: Iris Vegting
phone: +31 20 4444445
email: i.vegting1@amsterdamumc.nl
facility: 
status: Recruiting
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contact: 
country: Belgium
country: Germany
country: Netherlands
country: Poland
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Amsterdam UMC, location VUmc
investigator full name: Paul Knaapen
investigator title: Prinicipal Investigator
mesh term: Coronary Artery Disease
sharing ipd: Undecided