<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/NCT02198716</url>
  </required_header>
  <id_info>
    <org_study_id>Version 2.0 20.06.2008</org_study_id>
    <nct_id>NCT02198716</nct_id>
  </id_info>
  <brief_title>Xience or Vision Stent Management of Angina in the Elderly</brief_title>
  <acronym>XIMA</acronym>
  <official_title>Multi-centre, Randomised,Prospective Trial of Xience or Vision Stent, Management of Angina in the Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brighton and Sussex University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Brighton and Sussex University Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The treatment of complex coronary disease causing limiting symptoms of angina with&#xD;
      drug-eluting stent technology will prove superior to bare metal stent technology, with&#xD;
      respect to a combined endpoint of mortality, MI, requirement for target vessel&#xD;
      revascularisation and severe haemorrhage, in patients aged 80 or above.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2008</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Death/ Myocardial Infarction/Target Vessel Failure/Major Haemorrhage</measure>
    <time_frame>1 year</time_frame>
    <description>This is a composite outcome measure consisting of multiple measures of the events of Death, Myocardial Infarction,Target Vessel Failure, and/or Major Haemorrhage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Angina status</measure>
    <time_frame>1 year</time_frame>
    <description>This will be assessed in two ways:&#xD;
i) by interview according to the Canadian Cardiovascular Society classification&#xD;
ii) by patient self-assessment using the Seattle questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antianginal medication</measure>
    <time_frame>1 year</time_frame>
    <description>This will be assessed using a single point scoring system, where a point is scored for each of the following:&#xD;
Nitrate (sublingual or spray) used 1 or mnore times during week prior to question Nitrate (oral) beta-blocker Calcium antagonist Use of Nicorandil</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural success</measure>
    <time_frame>1 Year</time_frame>
    <description>Defined as TIMI 3 flow and &lt;30% stenosis in the main vessel and TIMI 3 flow in the side branch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACE (major adverse cardiovascular events)</measure>
    <time_frame>1 year</time_frame>
    <description>Defined as death, myocardial infarction, or emergency (within 24 hours) coronary artery bypass grafting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital complications</measure>
    <time_frame>1 Year</time_frame>
    <description>Major procedural complications include Death Myocardial infarction Emergency coronary artery bypass surgery Stroke Bleeding ('Thrombolysis In Myocardial Infarction)&#xD;
Minor procedural complications include Ventricular rhythm disorder (tachy or brady) requiring intervention (e.g defibrillation, DC cardioversion or temporary pacing) Bleeding Pseudoaneurysm requiring compression or surgery Vascular access complication extending hospital stay by 1 or more night Transient ischaemic attack Wire loss or fracture Stent loss Undeployed stent detachment from balloon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural cost</measure>
    <time_frame>1 Year</time_frame>
    <description>The difference in procedural cost will be assessed using a composite of the number of, guidewires, balloons and stents opened or used and procedural time. Prolonged hospital stay is a further potential cost pressure in this age group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">800</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Drug eluting stent</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Percutaneous coronary intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bare Metal Stent</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Percutaneous Coronary Intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Coronary Intervention using drug eluting stents</intervention_name>
    <description>Percutaneous Coronary Intervention using drug eluting stents</description>
    <arm_group_label>Drug eluting stent</arm_group_label>
    <other_name>Xience Drug eluting stent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Coronary Intervention using bare metal stents</intervention_name>
    <description>Percutaneous Coronary Intervention using bare metal stents</description>
    <arm_group_label>Bare Metal Stent</arm_group_label>
    <other_name>Vision BM stent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AGE&gt;80&#xD;
&#xD;
          -  Stable angina or acute coronary syndrome&#xD;
&#xD;
          -  Coronary narrowing suitable for stenting that is either ≥15mm long and/or ≤3mm&#xD;
             diameter.&#xD;
&#xD;
          -  Any lesion with high risk of restenosis eg chronic total occlusion, bifurcation,&#xD;
             severe calcification&#xD;
&#xD;
          -  Any left main stem lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute ST segment elevation myocardial infarction&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Platelet count =50 x 109/mm3&#xD;
&#xD;
          -  Patient life expectancy &lt; 1 year&#xD;
&#xD;
          -  Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or&#xD;
             stent drug elutant&#xD;
&#xD;
          -  Recent major GI haemorrhage (within 3 months)&#xD;
&#xD;
          -  Any previous cerebral bleeding episode&#xD;
&#xD;
          -  Participation in another investigational drug or device study&#xD;
&#xD;
          -  Patient unable to give consent&#xD;
&#xD;
          -  Clinical decision precluding the use of drug eluting stent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>80 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cardiac Research Unit</name>
      <address>
        <city>Brighton</city>
        <state>Sussex</state>
        <zip>BN2 1ES</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brighton and Sussex University Hospitals NHS Trust</investigator_affiliation>
    <investigator_full_name>Adam de Belder</investigator_full_name>
    <investigator_title>Consultant Cardiologist</investigator_title>
  </responsible_party>
  <keyword>Percutaneous coronary intervention</keyword>
  <keyword>Elderly</keyword>
  <keyword>Angina</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/NCT02198716
org study id: Version 2.0 20.06.2008
nct id: NCT02198716
lead sponsor: 
collaborator: 
has dmc: Yes
The treatment of complex coronary disease causing limiting symptoms of angina with
      drug-eluting stent technology will prove superior to bare metal stent technology, with
      respect to a combined endpoint of mortality, MI, requirement for target vessel
      revascularisation and severe haemorrhage, in patients aged 80 or above.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Death/ Myocardial Infarction/Target Vessel Failure/Major Haemorrhage
time frame: 1 year
description: This is a composite outcome measure consisting of multiple measures of the events of Death, Myocardial Infarction,Target Vessel Failure, and/or Major Haemorrhage
measure: Angina status
time frame: 1 year
description: This will be assessed in two ways:
i) by interview according to the Canadian Cardiovascular Society classification
ii) by patient self-assessment using the Seattle questionnaire
measure: Antianginal medication
time frame: 1 year
description: This will be assessed using a single point scoring system, where a point is scored for each of the following:
Nitrate (sublingual or spray) used 1 or mnore times during week prior to question Nitrate (oral) beta-blocker Calcium antagonist Use of Nicorandil
measure: Procedural success
time frame: 1 Year
description: Defined as TIMI 3 flow and <30% stenosis in the main vessel and TIMI 3 flow in the side branch
measure: MACE (major adverse cardiovascular events)
time frame: 1 year
description: Defined as death, myocardial infarction, or emergency (within 24 hours) coronary artery bypass grafting.
measure: In-hospital complications
time frame: 1 Year
description: Major procedural complications include Death Myocardial infarction Emergency coronary artery bypass surgery Stroke Bleeding ('Thrombolysis In Myocardial Infarction)
Minor procedural complications include Ventricular rhythm disorder (tachy or brady) requiring intervention (e.g defibrillation, DC cardioversion or temporary pacing) Bleeding Pseudoaneurysm requiring compression or surgery Vascular access complication extending hospital stay by 1 or more night Transient ischaemic attack Wire loss or fracture Stent loss Undeployed stent detachment from balloon
measure: Procedural cost
time frame: 1 Year
description: The difference in procedural cost will be assessed using a composite of the number of, guidewires, balloons and stents opened or used and procedural time. Prolonged hospital stay is a further potential cost pressure in this age group.
arm group label: Drug eluting stent
arm group type: Other
description: Percutaneous coronary intervention
arm group label: Bare Metal Stent
arm group type: Other
description: Percutaneous Coronary Intervention
intervention type: Procedure
intervention name: Percutaneous Coronary Intervention using drug eluting stents
description: Percutaneous Coronary Intervention using drug eluting stents
arm group label: Drug eluting stent
other name: Xience Drug eluting stent
intervention type: Procedure
intervention name: Percutaneous Coronary Intervention using bare metal stents
description: Percutaneous Coronary Intervention using bare metal stents
arm group label: Bare Metal Stent
other name: Vision BM stent
criteria: 
gender: All
minimum age: 80 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Brighton and Sussex University Hospitals NHS Trust
investigator full name: Adam de Belder
investigator title: Consultant Cardiologist
mesh term: Coronary Artery Disease