<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/NCT03283501</url>
  </required_header>
  <id_info>
    <org_study_id>001-2017</org_study_id>
    <nct_id>NCT03283501</nct_id>
  </id_info>
  <brief_title>Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL)</brief_title>
  <acronym>REVIVAL</acronym>
  <official_title>A Multicenter Observational Registry on Coronary Revascularization After Implantation of Transcatheter Aortic Valve Bioprosthesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Luigi Gonzaga Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>San Luigi Gonzaga Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The increasing operator experience combined with an improved performance of devices have led&#xD;
      to extend current transcatheter aortic valve implantation (TAVI) indications to patients at&#xD;
      low or intermediate risk. The safety of TAVI in this population was initially tested in small&#xD;
      observational studies and recently reported in the randomized PARTNER 2 and Surgical&#xD;
      Replacement and Transcatheter Aortic Valve Implantation Trial (SURTAVI) trials, which&#xD;
      demonstrated non- inferiority of TAVI in low or intermediate risk patients as compared to&#xD;
      surgery with respect to the primary endpoint of death or disabling stroke. In view of the&#xD;
      changes in the TAVI population, including younger patients with longer survival, the number&#xD;
      of patients that may require coronary revascularization after TAVI is expected to increase&#xD;
      over the time. Of note, challenges in performing percutaneous coronary interventions (PCI) in&#xD;
      patients previously treated with TAVI have been reported in small series.&#xD;
&#xD;
      Against this background, the purpose of this retrospective multicenter study is to evaluate&#xD;
      incidence, clinical indications, and feasibility of PCI performed after TAVI.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
        1. Evaluate the incidence of PCI after TAVI&#xD;
&#xD;
        2. Evaluate the clinical indications for PCI after TAVI&#xD;
&#xD;
        3. Evaluate the technical feasibility of PCI in patients with prior TAVI&#xD;
&#xD;
        4. Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after&#xD;
           TAVI&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 20, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the incidence of PCI after TAVI</measure>
    <time_frame>up to 5 year after TAVI implantation</time_frame>
    <description>Evaluate the incidence of PCI after TAVI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the clinical indications for PCI after TAVI</measure>
    <time_frame>intraoperative</time_frame>
    <description>Clinical indication for PCI: stable angina; documented silent ischemia; acute coronary syndrome/non-ST elevation myocardial infarction; acute coronary syndrome/ST elevation myocardial infarction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the technical feasibility of PCI in patients with prior TAVI</measure>
    <time_frame>intraoperative</time_frame>
    <description>Successful target coronary vessel revascularization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI</measure>
    <time_frame>up to 5 year after TAVI implantation</time_frame>
    <description>outcome defined as MACE (Major Adverse Coronary Event) a composite of Death, Myocardial Infarction, Target Lesion Failure</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Transcatheter Valve Implantation</condition>
  <condition>TAVI</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PCI after TAVI</intervention_name>
    <description>Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient undergoing PCI after TAVI, irrespective of clinical indications and&#xD;
        irrespective of whether planned or not at the time of TAVI&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient undergoing PCI after TAVI, irrespective of clinical indications and&#xD;
             irrespective of whether planned or not at the time of TAVI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Humanitas Research Hospital, Humanitas University</name>
      <address>
        <city>Rozzano</city>
        <state>Milan</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giulio Stefanini, MD, PhD</last_name>
      <phone>+390282241</phone>
      <email>giulio.stefanini@hunimed.eu</email>
    </contact>
    <investigator>
      <last_name>Giulio Stefanini, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy</name>
      <address>
        <city>Turin</city>
        <zip>10100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Enrico Cerrato, MD</last_name>
      <phone>+390119026602</phone>
      <email>enrico.cerrato@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Enrico Cerrato, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis Nombela-Franco, MD,PhD</last_name>
      <phone>+34 91 330 30 00</phone>
      <email>luisnombela@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Luis Nombela-Franco, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://cardiogroup.org</url>
    <description>Organization research website</description>
  </link>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Luigi Gonzaga Hospital</investigator_affiliation>
    <investigator_full_name>Enrico Cerrato</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>TAVI</keyword>
  <keyword>PCI</keyword>
  <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/NCT03283501
org study id: 001-2017
nct id: NCT03283501
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.
The increasing operator experience combined with an improved performance of devices have led
      to extend current transcatheter aortic valve implantation (TAVI) indications to patients at
      low or intermediate risk. The safety of TAVI in this population was initially tested in small
      observational studies and recently reported in the randomized PARTNER 2 and Surgical
      Replacement and Transcatheter Aortic Valve Implantation Trial (SURTAVI) trials, which
      demonstrated non- inferiority of TAVI in low or intermediate risk patients as compared to
      surgery with respect to the primary endpoint of death or disabling stroke. In view of the
      changes in the TAVI population, including younger patients with longer survival, the number
      of patients that may require coronary revascularization after TAVI is expected to increase
      over the time. Of note, challenges in performing percutaneous coronary interventions (PCI) in
      patients previously treated with TAVI have been reported in small series.

      Against this background, the purpose of this retrospective multicenter study is to evaluate
      incidence, clinical indications, and feasibility of PCI performed after TAVI.

      Objectives

        1. Evaluate the incidence of PCI after TAVI

        2. Evaluate the clinical indications for PCI after TAVI

        3. Evaluate the technical feasibility of PCI in patients with prior TAVI

        4. Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after
           TAVI
observational model: Cohort
time perspective: Retrospective
measure: Evaluate the incidence of PCI after TAVI
time frame: up to 5 year after TAVI implantation
description: Evaluate the incidence of PCI after TAVI
measure: Evaluate the clinical indications for PCI after TAVI
time frame: intraoperative
description: Clinical indication for PCI: stable angina; documented silent ischemia; acute coronary syndrome/non-ST elevation myocardial infarction; acute coronary syndrome/ST elevation myocardial infarction
measure: Evaluate the technical feasibility of PCI in patients with prior TAVI
time frame: intraoperative
description: Successful target coronary vessel revascularization
measure: Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI
time frame: up to 5 year after TAVI implantation
description: outcome defined as MACE (Major Adverse Coronary Event) a composite of Death, Myocardial Infarction, Target Lesion Failure
intervention type: Procedure
intervention name: PCI after TAVI
description: Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
country: Spain
url: http://cardiogroup.org
description: Organization research website
responsible party type: Principal Investigator
investigator affiliation: San Luigi Gonzaga Hospital
investigator full name: Enrico Cerrato
investigator title: Principal Investigator
sharing ipd: Undecided