<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/NCT03763747</url>
  </required_header>
  <id_info>
    <org_study_id>VP-0730</org_study_id>
    <nct_id>NCT03763747</nct_id>
  </id_info>
  <brief_title>Scoreflex NC - Scoring PTCA Catheter</brief_title>
  <official_title>Scoreflex NC - Scoring PTCA Catheter: A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Safety and Device Procedural Success of the Scoreflex NC Scoring PTCA Catheter in Subjects With Stenotic Coronary Arteries During Percutaneous Coronary Intervention.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OrbusNeich</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ClinLogix. LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>OrbusNeich</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, open label, multi-center, single arm, observational study designed to evaluate&#xD;
      the acute safety and device procedural success of the Scoreflex NC Scoring Percutaneous&#xD;
      Transluminal Coronary Angioplasty (PTCA) catheters in subjects with stenotic coronary&#xD;
      arteries during percutaneous coronary intervention.&#xD;
&#xD;
      Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC&#xD;
      Scoring PTCA catheter during their index procedure. All subjects will be screened according&#xD;
      to the protocol inclusion and exclusion criteria and will be followed through hospital&#xD;
      discharge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 27, 2019</start_date>
  <completion_date type="Actual">December 27, 2019</completion_date>
  <primary_completion_date type="Actual">December 27, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Device Procedural Success</measure>
    <time_frame>Peri-procedural (at Day 0)</time_frame>
    <description>Device procedural success consisting of the following:&#xD;
Successful delivery, inflation, deflation, and withdrawal of the study balloon&#xD;
No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the Scoreflex NC study balloon&#xD;
Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Angiographic Procedural Success</measure>
    <time_frame>Peri-procedural (at Day 0)</time_frame>
    <description>Angiographic Procedural Success defined as Final diameter stenosis ≤ 50% in at least one of the Scoreflex NC attempted lesions following completion of the interventional procedure, including adjunctive stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)</measure>
    <time_frame>Endpoints will be measured through hospital discharge (expected to be within 24 hours)</time_frame>
    <description>In-hospital Major Adverse Cardiac Events (MACE), a composite of:&#xD;
All death (cardiac and non-cardiac)&#xD;
Myocardial infarction (MI)&#xD;
Target Lesion Revascularization (TLR), clinically indicated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel</measure>
    <time_frame>Endpoint will be measured through hospital discharge (expected to be within 24 hours)</time_frame>
    <description>In-hospital stent thrombosis (ST) within the Target Vessel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)</measure>
    <time_frame>Endpoint will be measured through hospital discharge (expected to be within 24 hours)</time_frame>
    <description>Clinically Significant Arrhythmias (Requiring Intervention)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture</measure>
    <time_frame>Peri-procedural</time_frame>
    <description>Occurrence of Scoreflex NC Study Balloon rupture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Had Improvement in Minimum Lumen Diameter (MLD) Following Use of Scoreflex NC Catheter (Measured by Quantitative Coronary Angiography (QCA))</measure>
    <time_frame>Peri-procedural</time_frame>
    <description>Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA).&#xD;
Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Coronary Disease</condition>
  <condition>Myocardial Ischemia</condition>
  <condition>Heart Diseases</condition>
  <condition>Arteriosclerosis</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Scoreflex NC Scoring PTCA Catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm with investigational Scoreflex NC Scoring PTCA catheters</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Scoreflex NC Scoring PTCA catheter</intervention_name>
    <description>To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters</description>
    <arm_group_label>Scoreflex NC Scoring PTCA Catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Clinical Inclusion Criteria&#xD;
&#xD;
          1. Subject is ≥ 18 years of age.&#xD;
&#xD;
          2. Subject or a legally authorized representative must provide written informed consent&#xD;
             prior to any study related procedures.&#xD;
&#xD;
          3. Subject must agree not to participate in any other clinical study during&#xD;
             hospitalization for the index procedure that would interfere with the endpoints of&#xD;
             this study.&#xD;
&#xD;
          4. Subjects must have a single or double vessel coronary artery disease (CAD) and&#xD;
             clinical evidence of ischemic heart disease, such as CAD, stable / unstable angina or&#xD;
             silent ischemia.&#xD;
&#xD;
             Angiographic Inclusion Criteria&#xD;
&#xD;
          5. Subject must have de novo or restenotic lesion(s) in native coronary arteries,&#xD;
             including in-stent restenosis suitable for percutaneous coronary intervention.&#xD;
&#xD;
          6. A maximum of two lesions, including at least one target lesion, in up to two coronary&#xD;
             arteries.&#xD;
&#xD;
          7. Target lesion must have a reference vessel diameter (RVD) between 1.75 and 4.0 mm by&#xD;
             visual estimation.&#xD;
&#xD;
          8. Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may&#xD;
             include chronic total occlusions (CTO).&#xD;
&#xD;
          9. The non-target lesion must be located in different coronary artery from the Target&#xD;
             lesion.&#xD;
&#xD;
         10. Treatment of non-target lesion, if any, must be completed prior to treatment of target&#xD;
             lesion and must be deemed a clinical angiographic success as visually assessed by the&#xD;
             physician.&#xD;
&#xD;
        Clinical Exclusion Criteria:&#xD;
&#xD;
          1. Subject with a known hypersensitivity or contraindication to aspirin, heparin,&#xD;
             bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot&#xD;
             be adequately pre-medicated.&#xD;
&#xD;
          2. Subject with known diagnosis of STEMI or NSTEMI at index presentation or within 7 days&#xD;
             of study screening.&#xD;
&#xD;
          3. Subject with known pregnancy or is nursing. Women of child-bearing potential should&#xD;
             have a documented negative pregnancy test within 7 days before index procedure.&#xD;
&#xD;
          4. Planned or actual target lesion treatment with an unapproved device, atherectomy,&#xD;
             laser, cutting balloon or thrombectomy during the index procedure.&#xD;
&#xD;
          5. A serum creatinine level &gt; 2.0 mg/dl within 7 days prior to index procedure.&#xD;
&#xD;
          6. Cerebrovascular accident (CVA) within the past 6 months.&#xD;
&#xD;
          7. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.&#xD;
&#xD;
          8. Subject has a known left ventricular ejection fraction (LVEF) &lt;30% (LVEF may be&#xD;
             obtained at the time of the index procedure if the value is unknown, if necessary)&#xD;
&#xD;
          9. Target lesion located within an arterial or saphenous vein graft or graft anastomosis&#xD;
&#xD;
             Angiographic Exclusion Criteria&#xD;
&#xD;
         10. More than two lesions requiring treatment.&#xD;
&#xD;
         11. Target lesion longer than 30 mm by visual estimation.&#xD;
&#xD;
         12. Extreme angulation (90º or greater) proximal to or within the target lesion.&#xD;
&#xD;
         13. Previous percutaneous intervention of lesions in a target vessel (including side&#xD;
             branches) conducted within 9 months before the study procedure and located within 10&#xD;
             mm from the current target lesion.&#xD;
&#xD;
         14. Target lesion demonstrating severe dissection prior to planned deployment of the&#xD;
             Scoreflex NC device&#xD;
&#xD;
         15. Unprotected left main coronary artery disease. (Greater than 50% diameter stenosis)&#xD;
&#xD;
         16. Coronary artery spasm of the target vessel in the absence of a significant stenosis.&#xD;
&#xD;
         17. Target lesion with angiographic presence of probable or definite thrombus.&#xD;
&#xD;
         18. Target lesion involves a bifurcation requiring treatment with more than one stent or&#xD;
             pre-dilatation of a side branch &gt;2.0 mm in diameter.&#xD;
&#xD;
         19. Non-target lesion to be treated during the index procedure meets any of the following&#xD;
             criteria:&#xD;
&#xD;
               -  Located within a bypass graft (venous or arterial)&#xD;
&#xD;
               -  Left main location&#xD;
&#xD;
               -  Chronic total occlusion&#xD;
&#xD;
               -  Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1&#xD;
                  stent)&#xD;
&#xD;
               -  Treatment not deemed a clinical angiographic success&#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>David Kandzari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Piedmont Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Cardiac and Vascular Institute Research Foundation</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Heart Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta VA Healthcare System</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delmarva Heart Research Foundation Inc./Peninsula Regional Medical Center</name>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CentraCare Heart and Vascular Center</name>
      <address>
        <city>Saint Cloud</city>
        <state>Minnesota</state>
        <zip>56303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates Research, LLC</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <zip>38801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deborah Heart and Lung Center</name>
      <address>
        <city>Browns Mills</city>
        <state>New Jersey</state>
        <zip>08015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Lindner Research Center/The Christ Hospital Heart and Vascular</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Kandzari D, Hearne S, Kumar G, Sachdeva R, Adams G, Blossom B, Dahle T, Sanghvi K, Cohen MG, Imperi G, Riley R, Almonacid AP. Procedural Effectiveness With a Focused Force Scoring Angioplasty Catheter: Procedural and Clinical Outcomes From the Scoreflex NC Trial. Cardiovasc Revasc Med. 2022 Feb;35:85-90. doi: 10.1016/j.carrev.2021.03.013. Epub 2021 Mar 20.</citation>
    <PMID>33781677</PMID>
  </results_reference>
  <results_reference>
    <citation>Louvard Y, Medina A. Definitions and classifications of bifurcation lesions and treatment. EuroIntervention. 2015;11 Suppl V:V23-6. doi: 10.4244/EIJV11SVA5.</citation>
    <PMID>25983165</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <results_first_submitted>May 4, 2021</results_first_submitted>
  <results_first_submitted_qc>July 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 11, 2021</results_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Coronary Disease</keyword>
  <keyword>Myocardial Ischemia</keyword>
  <keyword>Heart Diseases</keyword>
  <keyword>Arteriosclerosis</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Arteriosclerosis</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT03763747/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT03763747/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter</title>
          <description>Single arm with investigational Scoreflex NC Scoring PTCA catheters&#xD;
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
              </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>Scoreflex NC Scoring PTCA Catheter</title>
          <description>Single arm with investigational Scoreflex NC Scoring PTCA catheters&#xD;
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="200"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>Lesions</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="221"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.3" spread="8.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="178"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian/Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian/Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cardiac History</title>
          <description>More than one Cardiac History measure may be reported for each participant.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>Prior Percutaneous Coronary Intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prior Coronary Artery Bypass Graft</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prior Myocardial Infarction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current Cardiac Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asymptomatic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Silent Ischemia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Stable Angina</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unstable Angina</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ST-Elevation Myocardial Infarction (STEMI)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cardiac Risk Factors</title>
          <description>More than one Cardiac Risk Factor may be reported for each participant.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <title>Cigarette Smoking (within 30 days)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Mellitus (Insulin requiring)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypercholesterolemia Requiring Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension Requiring Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Angiographic Characteristics: Vessel Location (Core Lab assessed)</title>
          <description>Analysis is based on the core lab assessed number of lesions (n=221).</description>
          <units>Lesions</units>
          <param>Count of Units</param>
          <units_analyzed>Lesions</units_analyzed>
          <class_list>
            <class>
              <title>Left Anterior Descending Artery (LAD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left Circumflex Artery (LCX)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right Coronary Artery (RCA)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Identified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Angiographic Characteristics: Lesion Location (Core Lab assessed)</title>
          <description>Analysis is based on the core lab assessed anatomic position in the vessel. The total number of lesions assessed is 221.</description>
          <units>Lesions</units>
          <param>Count of Units</param>
          <units_analyzed>Lesions</units_analyzed>
          <class_list>
            <class>
              <title>Ostial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Proximal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Middle</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Angiographic Characteristics: Lesion Characteristics (Core Lab assessed)</title>
          <description>Analysis is based on the core lab assessed number of lesions (n=221).</description>
          <units>Millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Lesions</units_analyzed>
          <class_list>
            <class>
              <title>Lesion Length</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.37" spread="12.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minimal Luminal Diameter</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.8" spread="0.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Angiographic Characteristics: Lesion Characteristics (Core Lab assessed)</title>
          <description>Analysis is based on the core lab assessed number of lesions (n=221).</description>
          <units>Lesions</units>
          <param>Count of Units</param>
          <units_analyzed>Lesions</units_analyzed>
          <class_list>
            <class>
              <title>Moderate/Severe Calcification</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate/Severe Tortuosity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Occlusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Thrombolysis in Myocardial Infarction (TIMI) Flow (Core Lab assessed)</title>
          <description>Analysis is based on the core lab assessed number of lesions (n=221).</description>
          <units>Lesions</units>
          <param>Count of Units</param>
          <units_analyzed>Lesions</units_analyzed>
          <class_list>
            <class>
              <title>0 (no perfusion)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 (penetration with minimal perfusion)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 (partial perfusion)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 (complete perfusion)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed)</title>
          <description>The Medina Type is a classification system of the types of significant lesions in the 3 segments of a bifurcation as determined angiographically.&#xD;
A value of 0 or 1 (0 in the absence of significant stenosis and 1 in the presence of a stenosis &gt;50%) is assigned to each of the 3 segments separated in the following order: proximal segment (PM), main distal segment (DM),side branch (SB), the values being separated by commas.(e.g. 1,1,1 would be considered the most complex with disease in all 3 segments.) Medina classification analysis results based upon all angiographic core lab lesions (n=221).</description>
          <units>Lesions</units>
          <param>Count of Units</param>
          <units_analyzed>Lesions</units_analyzed>
          <class_list>
            <class>
              <title>0,0,0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0,0,1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0,1,0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1,0,0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0,1,1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1,0,1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1,1,0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1,1,1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-bifurcation lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Device Procedural Success</title>
        <description>Device procedural success consisting of the following:&#xD;
Successful delivery, inflation, deflation, and withdrawal of the study balloon&#xD;
No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the Scoreflex NC study balloon&#xD;
Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure</description>
        <time_frame>Peri-procedural (at Day 0)</time_frame>
        <population>Analysis population consists of intent-to-treat subject population.</population>
        <group_list>
          <group group_id="O1">
            <title>Scoreflex NC Scoring PTCA Catheter</title>
            <description>Single arm with investigational Scoreflex NC Scoring PTCA catheters&#xD;
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Device Procedural Success</title>
          <description>Device procedural success consisting of the following:&#xD;
Successful delivery, inflation, deflation, and withdrawal of the study balloon&#xD;
No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the Scoreflex NC study balloon&#xD;
Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure</description>
          <population>Analysis population consists of intent-to-treat subject population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Angiographic Procedural Success</title>
        <description>Angiographic Procedural Success defined as Final diameter stenosis ≤ 50% in at least one of the Scoreflex NC attempted lesions following completion of the interventional procedure, including adjunctive stenting</description>
        <time_frame>Peri-procedural (at Day 0)</time_frame>
        <population>Analysis population consists of intent-to-treat subject population.</population>
        <group_list>
          <group group_id="O1">
            <title>Scoreflex NC Scoring PTCA Catheter</title>
            <description>Single arm with investigational Scoreflex NC Scoring PTCA catheters&#xD;
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Angiographic Procedural Success</title>
          <description>Angiographic Procedural Success defined as Final diameter stenosis ≤ 50% in at least one of the Scoreflex NC attempted lesions following completion of the interventional procedure, including adjunctive stenting</description>
          <population>Analysis population consists of intent-to-treat subject population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)</title>
        <description>In-hospital Major Adverse Cardiac Events (MACE), a composite of:&#xD;
All death (cardiac and non-cardiac)&#xD;
Myocardial infarction (MI)&#xD;
Target Lesion Revascularization (TLR), clinically indicated</description>
        <time_frame>Endpoints will be measured through hospital discharge (expected to be within 24 hours)</time_frame>
        <population>Analysis population consists of intent-to-treat subject population.</population>
        <group_list>
          <group group_id="O1">
            <title>Scoreflex NC Scoring PTCA Catheter</title>
            <description>Single arm with investigational Scoreflex NC Scoring PTCA catheters&#xD;
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)</title>
          <description>In-hospital Major Adverse Cardiac Events (MACE), a composite of:&#xD;
All death (cardiac and non-cardiac)&#xD;
Myocardial infarction (MI)&#xD;
Target Lesion Revascularization (TLR), clinically indicated</description>
          <population>Analysis population consists of intent-to-treat subject population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel</title>
        <description>In-hospital stent thrombosis (ST) within the Target Vessel</description>
        <time_frame>Endpoint will be measured through hospital discharge (expected to be within 24 hours)</time_frame>
        <population>Analysis population consists of intent-to-treat subject population.</population>
        <group_list>
          <group group_id="O1">
            <title>Scoreflex NC Scoring PTCA Catheter</title>
            <description>Single arm with investigational Scoreflex NC Scoring PTCA catheters&#xD;
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel</title>
          <description>In-hospital stent thrombosis (ST) within the Target Vessel</description>
          <population>Analysis population consists of intent-to-treat subject population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)</title>
        <description>Clinically Significant Arrhythmias (Requiring Intervention)</description>
        <time_frame>Endpoint will be measured through hospital discharge (expected to be within 24 hours)</time_frame>
        <population>Analysis population consists of intent-to-treat subject population.</population>
        <group_list>
          <group group_id="O1">
            <title>Scoreflex NC Scoring PTCA Catheter</title>
            <description>Single arm with investigational Scoreflex NC Scoring PTCA catheters&#xD;
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)</title>
          <description>Clinically Significant Arrhythmias (Requiring Intervention)</description>
          <population>Analysis population consists of intent-to-treat subject population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture</title>
        <description>Occurrence of Scoreflex NC Study Balloon rupture</description>
        <time_frame>Peri-procedural</time_frame>
        <population>Analysis population consists of intent-to-treat subject population. Site reported data represented on the use of 239 Scoreflex NC Scoring PTCA catheter study devices.</population>
        <group_list>
          <group group_id="O1">
            <title>Scoreflex NC Scoring PTCA Catheter</title>
            <description>Single arm with investigational Scoreflex NC Scoring PTCA catheters&#xD;
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture</title>
          <description>Occurrence of Scoreflex NC Study Balloon rupture</description>
          <population>Analysis population consists of intent-to-treat subject population. Site reported data represented on the use of 239 Scoreflex NC Scoring PTCA catheter study devices.</population>
          <units>Scoreflex NC Scoring PTCA catheters</units>
          <param>Count of Units</param>
          <units_analyzed>Scoreflex NC Scoring PTCA catheters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Scoreflex NC Scoring PTCA catheters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="239"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Had Improvement in Minimum Lumen Diameter (MLD) Following Use of Scoreflex NC Catheter (Measured by Quantitative Coronary Angiography (QCA))</title>
        <description>Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA).&#xD;
Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline.</description>
        <time_frame>Peri-procedural</time_frame>
        <population>Analysis population consists of intent-to-treat subject population. Please note that the data for Number of Participants that had Improvement in Minimum Lumen Diameter was not analyzable in 23 patients by the Angiographic Core Lab.</population>
        <group_list>
          <group group_id="O1">
            <title>Scoreflex NC Scoring PTCA Catheter</title>
            <description>Single arm with investigational Scoreflex NC Scoring PTCA catheters&#xD;
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Had Improvement in Minimum Lumen Diameter (MLD) Following Use of Scoreflex NC Catheter (Measured by Quantitative Coronary Angiography (QCA))</title>
          <description>Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA).&#xD;
Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline.</description>
          <population>Analysis population consists of intent-to-treat subject population. Please note that the data for Number of Participants that had Improvement in Minimum Lumen Diameter was not analyzable in 23 patients by the Angiographic Core Lab.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Scoreflex NC Scoring PTCA Catheter</title>
          <description>Single arm with investigational Scoreflex NC Scoring PTCA catheters&#xD;
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Target Lesion Revascularization Clinically Indicated TLR)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction (Non Q-wave)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial Infarction (Non Q-wave)</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Clinically Significant Arrhythmias (Requiring Intervention)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Stephen M. Rowland, PhD - Vice-President, Research and Development</name_or_title>
      <organization>OrbusNeich</organization>
      <phone>954-730-0711</phone>
      <email>srowland@orbusneich.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/NCT03763747
org study id: VP-0730
nct id: NCT03763747
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
A prospective, open label, multi-center, single arm, observational study designed to evaluate
      the acute safety and device procedural success of the Scoreflex NC Scoring Percutaneous
      Transluminal Coronary Angioplasty (PTCA) catheters in subjects with stenotic coronary
      arteries during percutaneous coronary intervention.

      Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC
      Scoring PTCA catheter during their index procedure. All subjects will be screened according
      to the protocol inclusion and exclusion criteria and will be followed through hospital
      discharge.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Device Procedural Success
time frame: Peri-procedural (at Day 0)
description: Device procedural success consisting of the following:
Successful delivery, inflation, deflation, and withdrawal of the study balloon
No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the Scoreflex NC study balloon
Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure
measure: Number of Participants With Angiographic Procedural Success
time frame: Peri-procedural (at Day 0)
description: Angiographic Procedural Success defined as Final diameter stenosis ≤ 50% in at least one of the Scoreflex NC attempted lesions following completion of the interventional procedure, including adjunctive stenting
measure: Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
time frame: Endpoints will be measured through hospital discharge (expected to be within 24 hours)
description: In-hospital Major Adverse Cardiac Events (MACE), a composite of:
All death (cardiac and non-cardiac)
Myocardial infarction (MI)
Target Lesion Revascularization (TLR), clinically indicated
measure: Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel
time frame: Endpoint will be measured through hospital discharge (expected to be within 24 hours)
description: In-hospital stent thrombosis (ST) within the Target Vessel
measure: Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)
time frame: Endpoint will be measured through hospital discharge (expected to be within 24 hours)
description: Clinically Significant Arrhythmias (Requiring Intervention)
measure: Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture
time frame: Peri-procedural
description: Occurrence of Scoreflex NC Study Balloon rupture
measure: Number of Participants That Had Improvement in Minimum Lumen Diameter (MLD) Following Use of Scoreflex NC Catheter (Measured by Quantitative Coronary Angiography (QCA))
time frame: Peri-procedural
description: Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA).
Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline.
arm group label: Scoreflex NC Scoring PTCA Catheter
arm group type: Experimental
description: Single arm with investigational Scoreflex NC Scoring PTCA catheters
intervention type: Device
intervention name: Scoreflex NC Scoring PTCA catheter
description: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
arm group label: Scoreflex NC Scoring PTCA Catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Kandzari, MD
role: Principal Investigator
affiliation: Piedmont Heart Institute
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Kandzari D, Hearne S, Kumar G, Sachdeva R, Adams G, Blossom B, Dahle T, Sanghvi K, Cohen MG, Imperi G, Riley R, Almonacid AP. Procedural Effectiveness With a Focused Force Scoring Angioplasty Catheter: Procedural and Clinical Outcomes From the Scoreflex NC Trial. Cardiovasc Revasc Med. 2022 Feb;35:85-90. doi: 10.1016/j.carrev.2021.03.013. Epub 2021 Mar 20.
PMID: 33781677
citation: Louvard Y, Medina A. Definitions and classifications of bifurcation lesions and treatment. EuroIntervention. 2015;11 Suppl V:V23-6. doi: 10.4244/EIJV11SVA5.
PMID: 25983165
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Heart Diseases
mesh term: Arteriosclerosis
mesh term: Ischemia
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 