<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/NCT03291925</url>
  </required_header>
  <id_info>
    <org_study_id>ICVHealth2016002</org_study_id>
    <nct_id>NCT03291925</nct_id>
  </id_info>
  <brief_title>Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI</brief_title>
  <acronym>CT-CA</acronym>
  <official_title>Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI: A Randomized Controlled Pilot Trial (CT-CA Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BC Centre for Improved Cardiovascular Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>BC Centre for Improved Cardiovascular Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study is a prospective, randomized, open-label trial that aims to assess the&#xD;
      feasibility of comparing a primary Computed tomography/Cardiac computed tomography&#xD;
      angiography (CT/CCTA) strategy (test arm) to a strategy combining routine use of CT/CCTA and&#xD;
      invasive CA (control arm) prior to a Transcatheter aortic valve implantation (TAVI)&#xD;
      procedure. The study will also estimate the rate of composite coronary adverse events&#xD;
      (myocardial infarction, post procedural coronary revascularization and cardiovascular&#xD;
      mortality) between the two arms at 90 days follow-up. The primary endpoint will be the&#xD;
      feasibility of recruitment and compliance with the study protocol at 2 sites in Canada and 1&#xD;
      site in Denmark. Additional clinical endpoints including: all-cause death at 90 days post&#xD;
      procedure, myocardial infarction at 90 days post procedure, unplanned PCI or CABG at 90 days&#xD;
      post procedure, stroke at 90 days post procedure, CA and PCI related cumulative vascular&#xD;
      complications events. This information will be used to inform the design of the definitive&#xD;
      efficacy trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>Prospective, randomized, open-label trial.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients enrolled in the study of all those that are eligible</measure>
    <time_frame>18 months</time_frame>
    <description>This is the primary outcome for this pilot study to assess feasibility of a larger trial.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial Infarction</measure>
    <time_frame>Peri-procedural (≤72h post procedure) and 90 days</time_frame>
    <description>According to Valvular Academic Research Consortium-2 (VARC-2) criteria.&#xD;
Periprocedural MI (≤72h post procedure).&#xD;
Spontaneous MI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unplanned revascularization</measure>
    <time_frame>90 days</time_frame>
    <description>Any unplanned coronary revascularization either with Percutaneous Coronary Intervention( PCI) or Coronary Artery Bypass Graft (CABG) post TAVI procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding complication</measure>
    <time_frame>Peri-procedural (≤72h post procedure) and 90 days</time_frame>
    <description>According to VARC-2 criteria.&#xD;
TAVI related ≤ 72h post TAVI&#xD;
Coronary procedure related ≤ 72h post CA or PCI (if staged TAVI-PCI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>90 days</time_frame>
    <description>According to VARC-2 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Kidney Injury</measure>
    <time_frame>90 days</time_frame>
    <description>According to VARC-2 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>90 days</time_frame>
    <description>An acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as assessed by a clinician and confirmed by at least one cerebral imaging study (CT or MRI). Stroke may be classified as ischaemic or haemorrhagic</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Severe Aortic Stenosis</condition>
  <condition>Transcatheter Aortic Valve Implantation</condition>
  <arm_group>
    <arm_group_label>Selective invasive angiography based on CT/CCTA imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo selective invasive angiography based on CT/CCTA imaging. Decision to procede with additional invasive CA will be based on adequacy of CT/CCTA evaluation and likelihood of significant coronary artery disease.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Invasive Cardiac Angiography</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo systematic invasive angiography.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Selective invasive angiography based on CT/CCTA imaging.</intervention_name>
    <arm_group_label>Selective invasive angiography based on CT/CCTA imaging</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Procedure/Surgery: Invasive angiography</intervention_name>
    <arm_group_label>Invasive Cardiac Angiography</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe aortic stenosis (Peak transvalvular gradient of ≥ 40mmHg on TTE or stress Echo,&#xD;
             Aortic valve area of &lt; 1.0cm2)&#xD;
&#xD;
          -  Symptoms suggestive of aortic stenosis (dyspnea, syncope, angina)&#xD;
&#xD;
          -  Eligible for TAVI (Upon evaluation by a multidisciplinary team composed of at least&#xD;
             one interventional cardiologist and one cardiothoracic surgeon)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe renal dysfunction Glomerular filtration rate &lt; 30 ml/min.&#xD;
&#xD;
          -  Severe left ventricular dysfunction LVEF ≤ 30%&#xD;
&#xD;
          -  Recent coronary angiography ≤ 6months from randomization&#xD;
&#xD;
          -  Recent PCI ≤ 6months from randomization&#xD;
&#xD;
          -  Recent or active acute coronary syndrome (New or worsening angina with or without&#xD;
             positive biomarkers or ECG changes).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathon Leipsic, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Paul's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shirley Wong, PhD</last_name>
    <phone>604-682-2344</phone>
    <email>3M@icvhealth.ubc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shirley Wong, PhD</last_name>
      <phone>604-682-2344</phone>
      <phone_ext>65676</phone_ext>
      <email>3M@icvhealth.ubc.ca</email>
    </contact>
    <investigator>
      <last_name>Leipsic Jonathon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>March 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</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>Aortic Valve Stenosis</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/NCT03291925
org study id: ICVHealth2016002
nct id: NCT03291925
lead sponsor: 
collaborator: 
has dmc: Yes
This pilot study is a prospective, randomized, open-label trial that aims to assess the
      feasibility of comparing a primary Computed tomography/Cardiac computed tomography
      angiography (CT/CCTA) strategy (test arm) to a strategy combining routine use of CT/CCTA and
      invasive CA (control arm) prior to a Transcatheter aortic valve implantation (TAVI)
      procedure. The study will also estimate the rate of composite coronary adverse events
      (myocardial infarction, post procedural coronary revascularization and cardiovascular
      mortality) between the two arms at 90 days follow-up. The primary endpoint will be the
      feasibility of recruitment and compliance with the study protocol at 2 sites in Canada and 1
      site in Denmark. Additional clinical endpoints including: all-cause death at 90 days post
      procedure, myocardial infarction at 90 days post procedure, unplanned PCI or CABG at 90 days
      post procedure, stroke at 90 days post procedure, CA and PCI related cumulative vascular
      complications events. This information will be used to inform the design of the definitive
      efficacy trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized, open-label trial.
primary purpose: Other
masking: None (Open Label)
measure: Number of patients enrolled in the study of all those that are eligible
time frame: 18 months
description: This is the primary outcome for this pilot study to assess feasibility of a larger trial.
measure: All-cause mortality
time frame: 90 days
measure: Myocardial Infarction
time frame: Peri-procedural (≤72h post procedure) and 90 days
description: According to Valvular Academic Research Consortium-2 (VARC-2) criteria.
Periprocedural MI (≤72h post procedure).
Spontaneous MI.
measure: Unplanned revascularization
time frame: 90 days
description: Any unplanned coronary revascularization either with Percutaneous Coronary Intervention( PCI) or Coronary Artery Bypass Graft (CABG) post TAVI procedure.
measure: Bleeding complication
time frame: Peri-procedural (≤72h post procedure) and 90 days
description: According to VARC-2 criteria.
TAVI related ≤ 72h post TAVI
Coronary procedure related ≤ 72h post CA or PCI (if staged TAVI-PCI)
measure: Device success
time frame: 90 days
description: According to VARC-2 criteria.
measure: Acute Kidney Injury
time frame: 90 days
description: According to VARC-2 criteria.
measure: Stroke
time frame: 90 days
description: An acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as assessed by a clinician and confirmed by at least one cerebral imaging study (CT or MRI). Stroke may be classified as ischaemic or haemorrhagic
arm group label: Selective invasive angiography based on CT/CCTA imaging
arm group type: Experimental
description: Patients will undergo selective invasive angiography based on CT/CCTA imaging. Decision to procede with additional invasive CA will be based on adequacy of CT/CCTA evaluation and likelihood of significant coronary artery disease.
arm group label: Invasive Cardiac Angiography
arm group type: Active Comparator
description: Patients will undergo systematic invasive angiography.
intervention type: Procedure
intervention name: Selective invasive angiography based on CT/CCTA imaging.
arm group label: Selective invasive angiography based on CT/CCTA imaging
intervention type: Procedure
intervention name: Procedure/Surgery: Invasive angiography
arm group label: Invasive Cardiac Angiography
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jonathon Leipsic, MD
role: Principal Investigator
affiliation: St. Paul's Hospital
last name: Shirley Wong, PhD
phone: 604-682-2344
email: 3M@icvhealth.ubc.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
sharing ipd: No