<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/NCT01673893</url>
  </required_header>
  <id_info>
    <org_study_id>K061680</org_study_id>
    <nct_id>NCT01673893</nct_id>
  </id_info>
  <brief_title>ClearWay Rx Readmission Registry</brief_title>
  <acronym>ClearWay</acronym>
  <official_title>ClearWay Rx Readmission Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiovascular Institute of the South Clinical Research Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiovascular Institute of the South Clinical Research Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this registry is to determine if delivery of weight adjusted, in a large dose&#xD;
      with either Abcixmab or Eptifibitide through the ClearWay™ RX, in patients admitted for&#xD;
      primary coronary intervention lowers readmission rate. This is done in comparison to the&#xD;
      historical control of the Medicare/Medicaid readmission database. The registry will record&#xD;
      the use of the product during the index procedure, and determine whether or not the patient&#xD;
      was readmitted within 30 days, related to the index procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary goal of this registry is to prospectively assess if delivery of weight adjusted,&#xD;
      bolus only with either abcixmab or eptifibitide through the ClearWay™ RX in patients admitted&#xD;
      for primary PCI lowers readmission rate in comparison to the historical control of the&#xD;
      Medicare/Medicaid readmission database. The registry will record the use of the product&#xD;
      during the index procedure, and assess whether or not the patient was readmitted within 30&#xD;
      days, related to the index procedure.&#xD;
&#xD;
      The ClearWay™ RX Local Therapeutic Infusion Catheter is a micro-porous PTFE balloon catheter&#xD;
      designed for the localized infusion of various diagnostic and therapeutic agents into the&#xD;
      coronary and peripheral vasculature. The ClearWay™ RX creates a low pressure fluid layer that&#xD;
      surrounds the balloon, allowing more effective delivery of a prescribed therapeutic agent,&#xD;
      without excessive stress and uncontrollable mechanical disruption seen with more traditional&#xD;
      elastomeric devices. In addition, the ClearWay™ RX is a low pressure irrigating balloon&#xD;
      system and non-compliant balloon that limits the amount of mechanical stress on the vessel&#xD;
      wall.&#xD;
&#xD;
      The objective of this prospective registry is to evaluate whether intracoronary (IC) delivery&#xD;
      of Glycoprotein IIb/IIIa inhibitors (GP IIb/IIIa) during Primary Coronary Intervention (PCI)&#xD;
      can reduce the likelihood of 30 day readmissions as a result of the original coronary&#xD;
      intervention. Intracoronary delivery of GP IIb/IIa inhibitor Abciximab in ST Elevation&#xD;
      Myocardial Infarction has shown to reduce myocardial infarct size, no reflow or slow flow,&#xD;
      improve TIMI flow and Myocardial Blush Grade2,3. The ICE trial4 (N=376) compared IC delivery&#xD;
      of GP IIb/IIa inhibitor Eptifibitide bolus only administration, bolus with maintenance&#xD;
      infusion of Eptifibitide, to standard intravenous (IV) bolus with maintenance infusion. At 24&#xD;
      month follow up, the Major Adverse Coronary Events (MACE) rate was lower in the IC bolus only&#xD;
      group (2.5%) versus IC bolus and maintenance infusion (5.8%), and IV bolus with maintenance&#xD;
      infusion (10.8%). Further, target lesion revascularization, and readmission rates were&#xD;
      significantly lower in the IC bolus only arm, (10.9% versus 16.8% and 28% respectively).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>30 Day Readmissions</measure>
    <time_frame>30 Days</time_frame>
    <description>Collecting data for STEMI and NSTEMI patients for 30 day readmissions after the STEMI or NSTEMI with use of the clearway catheter during the procedure.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>ST elevation myocardial infarction</arm_group_label>
    <description>The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.&#xD;
1st Group/Cohort - ST elevation myocardial infarction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-ST elevation myocardial infarction/ACS/UNSTABLE ANGINA</arm_group_label>
    <description>The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.&#xD;
2nd Group/Cohort - Non-ST elevation myocardial infarction/ACS/Unstable Angina</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ClearWay™ Rx catheter</intervention_name>
    <arm_group_label>Non-ST elevation myocardial infarction/ACS/UNSTABLE ANGINA</arm_group_label>
    <arm_group_label>ST elevation myocardial infarction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients presenting with myocardial infarction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute Coronary Syndrome (ST elevation myocardial infarction or Non ST elevation&#xD;
             myocardial infarction) patients requiring the use of the ClearWay™ Rx local&#xD;
             therapeutic infusion catheter for intracoronary delivery of GP IIb/IIIa inhibitor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not meeting the above inclusion criterion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nick Cavros, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiovascular Institute of the South</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiovascular Institute of the South Clinical Research Corporation</name>
      <address>
        <city>Lafayette</city>
        <state>Louisiana</state>
        <zip>70503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Krumholz HM, Merrill AR, Schone EM, Schreiner GC, Chen J, Bradley EH, Wang Y, Wang Y, Lin Z, Straube BM, Rapp MT, Normand SL, Drye EE. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009 Sep;2(5):407-13. doi: 10.1161/CIRCOUTCOMES.109.883256. Epub 2009 Jul 9.</citation>
    <PMID>20031870</PMID>
  </reference>
  <reference>
    <citation>Thiele, et al. Circulation 2008 Vol. 118</citation>
  </reference>
  <reference>
    <citation>Romagnoli E, Burzotta F, Trani C, Biondi-Zoccai GG, Giannico F, Crea F. Rationale for intracoronary administration of abciximab. J Thromb Thrombolysis. 2007 Feb;23(1):57-63. doi: 10.1007/s11239-006-9000-0.</citation>
    <PMID>17160551</PMID>
  </reference>
  <reference>
    <citation>Hassan W, Al-Sergani H, Al Buraiki J, Dunn B, Al Turki F, Akhras N, Elshaer F, Nawaz M, Kharabsheh S, ElKum N. Immediate and intermediate results of intracoronary stand-alone bolus administration of eptifibatide during coronary intervention (ICE) study. Am Heart J. 2007 Aug;154(2):345-51. doi: 10.1016/j.ahj.2007.04.020.</citation>
    <PMID>17643587</PMID>
  </reference>
  <reference>
    <citation>Curtis JP, Schreiner G, Wang Y, Chen J, Spertus JA, Rumsfeld JS, Brindis RG, Krumholz HM. All-cause readmission and repeat revascularization after percutaneous coronary intervention in a cohort of medicare patients. J Am Coll Cardiol. 2009 Sep 1;54(10):903-7. doi: 10.1016/j.jacc.2009.04.076.</citation>
    <PMID>19712799</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>January 25, 2017</results_first_submitted>
  <results_first_submitted_qc>November 29, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 24, 2018</results_first_posted>
  <last_update_submitted>November 1, 2018</last_update_submitted>
  <last_update_submitted_qc>November 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ClearWay</keyword>
  <keyword>Glycoprotein</keyword>
  <keyword>Primary Coronary Intervention</keyword>
  <keyword>Abciximab</keyword>
  <keyword>ST Elevation Myocardial Infarction</keyword>
  <keyword>Non-ST Elevation Myocardial Infarction</keyword>
  <keyword>Medicare</keyword>
  <keyword>Medicaid</keyword>
  <keyword>Registry</keyword>
  <keyword>catheterization</keyword>
  <keyword>readmission</keyword>
  <keyword>Acute Coronary Syndrome</keyword>
  <keyword>ClearwayRx Catheter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Readmission Results</title>
          <description>The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.&#xD;
ClearWay™ Rx catheter</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ST Elevation Myocardial Infarction</title>
          <description>The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.&#xD;
1st Group/Cohort - STEMI: ST elevation myocardial infarction</description>
        </group>
        <group group_id="B2">
          <title>Non ST Elevation Myocardial Infarction/ACS/UNSTABLE ANGINA</title>
          <description>The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.&#xD;
2nd Group/Cohort - NSTEMI: Non-ST elevation myocardial infarction/ACS/Unstable Angina</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="59"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;50 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 to 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>65 to 75 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 75 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>30 Day Readmissions</title>
        <description>Collecting data for STEMI and NSTEMI patients for 30 day readmissions after the STEMI or NSTEMI with use of the clearway catheter during the procedure.</description>
        <time_frame>30 Days</time_frame>
        <population>The above documentation shows the number of readmissions within 30days of post PCI with 7 subjects. The number of cardiovascular Admissiosn within 30 days that were not preplanned or elective are 3. The number of subjects compliant with the dual anti platelet therapy consists of 59 subjects who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>No. Re-admission Within 30-days Post Pci</title>
            <description>No. of Re-admission within 30-days post pci</description>
          </group>
          <group group_id="O2">
            <title>No. of Cardiovascular Admissions Within 30-days</title>
            <description>No. of Cardiovascular Admissions within 30-days: not preplanned, not elective</description>
          </group>
          <group group_id="O3">
            <title>No. of Patients Compliant With DAPT</title>
            <description>No. of patients compliant with Dual Anti Platelet Therapy</description>
          </group>
        </group_list>
        <measure>
          <title>30 Day Readmissions</title>
          <description>Collecting data for STEMI and NSTEMI patients for 30 day readmissions after the STEMI or NSTEMI with use of the clearway catheter during the procedure.</description>
          <population>The above documentation shows the number of readmissions within 30days of post PCI with 7 subjects. The number of cardiovascular Admissiosn within 30 days that were not preplanned or elective are 3. The number of subjects compliant with the dual anti platelet therapy consists of 59 subjects who completed the study.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed on 7 participants with re-admissions within 30 days post pci and 3 participants who had Cardiovascular Admissions within 30-days that were not preplanned or elective. Re-admissions were captured for data purposes only, not followed.</desc>
      <group_list>
        <group group_id="E1">
          <description>Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed on 7 participants with re-admissions within 30 days post pci and 3 participants who had Cardiovascular Admissions within 30-days that were not preplanned or elective. Re-admissions were captured for data purposes only, not followed.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Deanna K. Benoit, LPN, CCRC</name_or_title>
      <organization>Cardiovascular Institute of the South Clinical Research Corporation</organization>
      <phone>985-876-0300 ext 5613</phone>
      <email>deanna.benoit@cardio.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01673893
org study id: K061680
nct id: NCT01673893
lead sponsor: 
has dmc: No
The purpose of this registry is to determine if delivery of weight adjusted, in a large dose
      with either Abcixmab or Eptifibitide through the ClearWay™ RX, in patients admitted for
      primary coronary intervention lowers readmission rate. This is done in comparison to the
      historical control of the Medicare/Medicaid readmission database. The registry will record
      the use of the product during the index procedure, and determine whether or not the patient
      was readmitted within 30 days, related to the index procedure.
The primary goal of this registry is to prospectively assess if delivery of weight adjusted,
      bolus only with either abcixmab or eptifibitide through the ClearWay™ RX in patients admitted
      for primary PCI lowers readmission rate in comparison to the historical control of the
      Medicare/Medicaid readmission database. The registry will record the use of the product
      during the index procedure, and assess whether or not the patient was readmitted within 30
      days, related to the index procedure.

      The ClearWay™ RX Local Therapeutic Infusion Catheter is a micro-porous PTFE balloon catheter
      designed for the localized infusion of various diagnostic and therapeutic agents into the
      coronary and peripheral vasculature. The ClearWay™ RX creates a low pressure fluid layer that
      surrounds the balloon, allowing more effective delivery of a prescribed therapeutic agent,
      without excessive stress and uncontrollable mechanical disruption seen with more traditional
      elastomeric devices. In addition, the ClearWay™ RX is a low pressure irrigating balloon
      system and non-compliant balloon that limits the amount of mechanical stress on the vessel
      wall.

      The objective of this prospective registry is to evaluate whether intracoronary (IC) delivery
      of Glycoprotein IIb/IIIa inhibitors (GP IIb/IIIa) during Primary Coronary Intervention (PCI)
      can reduce the likelihood of 30 day readmissions as a result of the original coronary
      intervention. Intracoronary delivery of GP IIb/IIa inhibitor Abciximab in ST Elevation
      Myocardial Infarction has shown to reduce myocardial infarct size, no reflow or slow flow,
      improve TIMI flow and Myocardial Blush Grade2,3. The ICE trial4 (N=376) compared IC delivery
      of GP IIb/IIa inhibitor Eptifibitide bolus only administration, bolus with maintenance
      infusion of Eptifibitide, to standard intravenous (IV) bolus with maintenance infusion. At 24
      month follow up, the Major Adverse Coronary Events (MACE) rate was lower in the IC bolus only
      group (2.5%) versus IC bolus and maintenance infusion (5.8%), and IV bolus with maintenance
      infusion (10.8%). Further, target lesion revascularization, and readmission rates were
      significantly lower in the IC bolus only arm, (10.9% versus 16.8% and 28% respectively).
observational model: Cohort
time perspective: Prospective
measure: 30 Day Readmissions
time frame: 30 Days
description: Collecting data for STEMI and NSTEMI patients for 30 day readmissions after the STEMI or NSTEMI with use of the clearway catheter during the procedure.
arm group label: ST elevation myocardial infarction
description: The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.
1st Group/Cohort - ST elevation myocardial infarction
arm group label: Non-ST elevation myocardial infarction/ACS/UNSTABLE ANGINA
description: The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.
2nd Group/Cohort - Non-ST elevation myocardial infarction/ACS/Unstable Angina
intervention type: Device
intervention name: ClearWay™ Rx catheter
arm group label: Non-ST elevation myocardial infarction/ACS/UNSTABLE ANGINA
arm group label: ST elevation myocardial infarction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nick Cavros, MD
role: Principal Investigator
affiliation: Cardiovascular Institute of the South
facility: 
country: United States
citation: Krumholz HM, Merrill AR, Schone EM, Schreiner GC, Chen J, Bradley EH, Wang Y, Wang Y, Lin Z, Straube BM, Rapp MT, Normand SL, Drye EE. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009 Sep;2(5):407-13. doi: 10.1161/CIRCOUTCOMES.109.883256. Epub 2009 Jul 9.
PMID: 20031870
citation: Thiele, et al. Circulation 2008 Vol. 118
citation: Romagnoli E, Burzotta F, Trani C, Biondi-Zoccai GG, Giannico F, Crea F. Rationale for intracoronary administration of abciximab. J Thromb Thrombolysis. 2007 Feb;23(1):57-63. doi: 10.1007/s11239-006-9000-0.
PMID: 17160551
citation: Hassan W, Al-Sergani H, Al Buraiki J, Dunn B, Al Turki F, Akhras N, Elshaer F, Nawaz M, Kharabsheh S, ElKum N. Immediate and intermediate results of intracoronary stand-alone bolus administration of eptifibatide during coronary intervention (ICE) study. Am Heart J. 2007 Aug;154(2):345-51. doi: 10.1016/j.ahj.2007.04.020.
PMID: 17643587
citation: Curtis JP, Schreiner G, Wang Y, Chen J, Spertus JA, Rumsfeld JS, Brindis RG, Krumholz HM. All-cause readmission and repeat revascularization after percutaneous coronary intervention in a cohort of medicare patients. J Am Coll Cardiol. 2009 Sep 1;54(10):903-7. doi: 10.1016/j.jacc.2009.04.076.
PMID: 19712799
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 