<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/NCT03284229</url>
  </required_header>
  <id_info>
    <org_study_id>ELCA-1016</org_study_id>
    <nct_id>NCT03284229</nct_id>
  </id_info>
  <brief_title>Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD</brief_title>
  <acronym>ELCA-CAD</acronym>
  <official_title>A Prospective, Open Label, Non-randomized, Single-Arm, Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA® in Treatment of Patients With Single or Multivessel Coronary Artery Disease (CAD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spectranetics Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CBCC-VIBGYOR Research Pvt. Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Spectranetics Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Prospective, Open label, Non-randomized, Single-Arm, Multicenter Study to Evaluate&#xD;
      the Procedural Safety and Efficacy of ELCA® in Treatment of Patients with Single or&#xD;
      Multivessel Coronary Artery Disease (CAD). Up to 30 patients will be enrolled at up to 05&#xD;
      Indian study sites. Patients will be followed from enrollment through 30 days ± 7 days for&#xD;
      the effectiveness and safety endpoints at the study centre.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each subject will be followed from enrollment through 30 days ± 7 days for the effectiveness&#xD;
      and safety endpoints. Upon enrollment after obtaining a written informed consent, each&#xD;
      patient will be assigned a unique identification number. Only patients eligible to undergo&#xD;
      cardiac catheterizations as per routine practice will be considered for the study.&#xD;
      Premedication of patients will be as per the investigator's routine practice. All patient&#xD;
      data will be recorded on patient data forms.&#xD;
&#xD;
      Screening: This will be performed prior to the cardiac catheterization procedure. Only&#xD;
      patients who have consented and fulfill the selection criteria will be enrolled.&#xD;
      Additionally, ECG and Echocardiogram will be done using hospital equipment to ensure&#xD;
      fulfillment of inclusion/exclusion criteria.&#xD;
&#xD;
      Procedure: The entire procedure will be carried out as per the site routine practice and the&#xD;
      device will be used as per the IFU.&#xD;
&#xD;
      Clinic follow up visit (30 ± 7 days): The subject will return to the clinic at 1 month to&#xD;
      evaluate angina status as per the CCS classification, AE assessments, concomitant medications&#xD;
      and any coronary intervention that has occurred since the previous contact.&#xD;
&#xD;
      An electrocardiogram (ECG) will be repeated during the clinic visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">May 21, 2018</completion_date>
  <primary_completion_date type="Actual">May 21, 2018</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>
    <intervention_model_description>As per the 25th SEC (Cardiovascular &amp; Renal) meeting which deliberated the proposals on 30-10-2015 and recommended the firm (Spectranetics Corporation - Sponsor) shall conduct a Bridging study in Indian Population at least 25 patients with coronary artery disease. The directorate suggested that the sponsor submit a protocol for the study in India for clinical trial approval. Considering the 5 dropouts, Sponsor has set up this protocol to conduct the Excimer Laser Coronary Atherectomy (ELCA®) study in India on 30 eligible patients across 05 sites as a Stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA) in single or multi-vessel coronary artery disease.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion</measure>
    <time_frame>Procedure</time_frame>
    <description>Successful crossing of the Laser Catheter across the entire length of the stenotic lesion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure</measure>
    <time_frame>Procedure</time_frame>
    <description>Target lesions with less than 50% residual stenosis after laser and adjunctive therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias</measure>
    <time_frame>30 days</time_frame>
    <description>Freedom from Major Adverse Cardiac Events (MACE) defined as Death, Non-Q-wave and Q-wave myocardial infarction (MI), Target Lesion Revascularization, Cardiac tamponade and life threatening arrhythmias.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TIMI Flow</measure>
    <time_frame>pre-procedure and post-procedure</time_frame>
    <description>To determine post-procedural TIMI Flow grade. Changes of TIMI Grade flow after Index Procedure by measuring pre-procedure TIMI grade flow and post-procedure TIMI grade flow.&#xD;
TIMI flow is a scoring system from 0-3 referring to levels of coronary blood flow assessed during percutaneous coronary angioplasty. TIMI flow was assessed before and after the procedure. TIMI grade flow 0-3 are as described below.&#xD;
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion.&#xD;
TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.&#xD;
TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory.&#xD;
TIMI 3 is normal flow which fills the distal coronary bed completely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity</measure>
    <time_frame>Procedure</time_frame>
    <description>Tortuosity from coronary angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lesion Morphology - Eccentricity of Coronary Lesion</measure>
    <time_frame>Procedure</time_frame>
    <description>Eccentricity from coronary angiography as concentric (symmetric) or eccentric (asymmetric)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lesion Morphology - Contour as a Lesion Characteristic</measure>
    <time_frame>Procedure</time_frame>
    <description>Contour from coronary angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lesion Morphology - Bifurcation (Branch or Division of Artery)</measure>
    <time_frame>Procedure</time_frame>
    <description>Bifurcation from coronary angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants With Device-related Complications During Procedure</measure>
    <time_frame>Procedure</time_frame>
    <description>To determine device related complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants With Procedure-related Complications During Procedure</measure>
    <time_frame>Procedure</time_frame>
    <description>To determine procedure related complications</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Excimer Laser Coronary Atherectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ELCA® in patients with single or multivessel CAD either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA). The entire procedure will be carried out as per the site routine practice and the device will be used as per the 'Instruction for Use'. Treating physicians/study investigators will be trained by the study Sponsor on the study protocol and procedures prior to clinical investigation procedure. Subject preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Excimer Laser Coronary Atherectomy</intervention_name>
    <description>Excimer Laser Coronary Atherectomy (ELCA ®) uses the high energy, monochromatic light beam to alter or dissolve (vaporize) the plaque without damaging the surrounding tissue. Fiber-optic catheters are used to deliver this light beam. For endovascular applications, Xenon Chloride excimer laser is used and its fiber-optic catheter has multiple small fibers, rather than just a few large fibers, in order to be flexible enough to navigate in the arterial tree.</description>
    <arm_group_label>Excimer Laser Coronary Atherectomy</arm_group_label>
    <other_name>ELCA Coronary Laser Atherectomy Catheters (OTW and RX)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have at least one severely stenotic lesion (greater than or equal to 80% diameter&#xD;
             stenosis as assessed by visual estimation)&#xD;
&#xD;
          -  Haemodynamically stable patients coming to the site for cardiac catheterization and&#xD;
             angiography for various indications and who fulfill all the following criteria:&#xD;
&#xD;
          -  Have no clinically significant cardiac arrhythmias, based on ECG results&#xD;
&#xD;
          -  Have no evidence of valvular pathology, based on echocardiogram results&#xD;
&#xD;
          -  Have ≥30% left ventricular ejection fraction (LVEF), based on echocardiogram results.&#xD;
&#xD;
          -  Angiographic evidence of calcification or a chronic total occlusion&#xD;
&#xD;
          -  Vessel reference diameter greater than or equal to 2.0 mm&#xD;
&#xD;
          -  Patient is willing and able to comply with study requirements&#xD;
&#xD;
          -  Women of child bearing potential, willing to use at least two methods of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of acute coronary syndrome within 3 months prior to index procedure&#xD;
&#xD;
          -  Evidence of acute ischemic events&#xD;
&#xD;
          -  Cardiogenic and non-cardiogenic shock&#xD;
&#xD;
          -  Active bleeding or coagulopathy&#xD;
&#xD;
          -  Previous coronary angioplasty within 6 months of the index procedure&#xD;
&#xD;
          -  Patients participating in trial for another investigational device/medicine within 1&#xD;
             month prior to enrolment in this study&#xD;
&#xD;
          -  Acute or Chronic renal failure, Impaired renal function (serum creatinine &gt; 2.5 mg/dl&#xD;
             or 221 umol/l) determined within 72 hours prior to index procedure.&#xD;
&#xD;
          -  Known allergies to the following: Aspirin, Clopidogrel or Ticlopidine, Heparin,&#xD;
             Sirolimus or its derivatives, contrast agent (that cannot be adequately&#xD;
             pre-medicated), or any metal&#xD;
&#xD;
          -  Planned surgery within 6 months of enrollment in this study&#xD;
&#xD;
          -  Life expectancy less than 6 months&#xD;
&#xD;
          -  Patients known to be suffering from substance abuse (alcohol or drug)&#xD;
&#xD;
          -  Patients with any other significant co-morbid illness which in the opinion of the&#xD;
             investigator is not conducive of inclusion in the study.&#xD;
&#xD;
          -  Known or suspected Pregnancy&#xD;
&#xD;
          -  Patients not willing to provide written informed consent&#xD;
&#xD;
          -  In the investigators opinion subjects will not be able to comply with the follow-up&#xD;
             requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Krygier, MBA</last_name>
    <role>Study Director</role>
    <affiliation>Spectranetics Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Escorts Heart Institute &amp; Research Centre Limited</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>160011</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>All Indian Institute of Medical Sciences (AIIMS)</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Health Private Limited, Medanta - The Medicity</name>
      <address>
        <city>Gurgaon</city>
        <state>Haryana</state>
        <zip>122001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sri Jayadeva Institute of Cardiovascular Sciences and Research</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560069</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lilavati Hospital and Research Centre</name>
      <address>
        <city>Bandra</city>
        <state>Mumbai</state>
        <zip>100050</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>http://www.spectranetics.com/resources/ifu-library/</url>
    <description>ELCA laser system and catheter IFUs</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <results_first_submitted>July 23, 2020</results_first_submitted>
  <results_first_submitted_qc>September 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 18, 2020</results_first_posted>
  <last_update_submitted>September 16, 2020</last_update_submitted>
  <last_update_submitted_qc>September 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ELCA</keyword>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>India</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</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>October 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03284229/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>31 patients were screened. 3 patients were screen failure. 28 patients enrolled in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Enrolled</title>
          <description>Excimer Laser Coronary Atherectomy (ELCA) Enrolled Patients</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Enrolled</title>
          <description>Enrolled Patients</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.04" spread="8.26"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>India</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <description>Height (cms)</description>
          <units>cms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163.50" spread="8.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <description>Weight (Kgs)</description>
          <units>kgs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.80" spread="11.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Angina Class</title>
          <description>Angina status or myocardial ischemia assessment as per the Canadian Cardiovascular Society (CCS) Classification.&#xD;
Grade I - ordinary physical activity does not cause angina. Angina with strenuous or rapid or prolonged exertion at work or recreation.&#xD;
Grade II - Slight limitation of ordinary activity. Grade III - Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace.&#xD;
Grade IV - Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Class 0/I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion</title>
        <description>Successful crossing of the Laser Catheter across the entire length of the stenotic lesion</description>
        <time_frame>Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enrolled</title>
            <description>Enrolled Patients</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion</title>
          <description>Successful crossing of the Laser Catheter across the entire length of the stenotic lesion</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Success</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure</title>
        <description>Target lesions with less than 50% residual stenosis after laser and adjunctive therapy.</description>
        <time_frame>Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enrolled</title>
            <description>Enrolled Patients</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure</title>
          <description>Target lesions with less than 50% residual stenosis after laser and adjunctive therapy.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 50%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 50%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias</title>
        <description>Freedom from Major Adverse Cardiac Events (MACE) defined as Death, Non-Q-wave and Q-wave myocardial infarction (MI), Target Lesion Revascularization, Cardiac tamponade and life threatening arrhythmias.</description>
        <time_frame>30 days</time_frame>
        <population>Safety success includes 25 subjects that completed follow up and 3 subjects that were Lost To Follow Up</population>
        <group_list>
          <group group_id="O1">
            <title>Enrolled</title>
            <description>Enrolled Patients, including Lost To Follow Up</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias</title>
          <description>Freedom from Major Adverse Cardiac Events (MACE) defined as Death, Non-Q-wave and Q-wave myocardial infarction (MI), Target Lesion Revascularization, Cardiac tamponade and life threatening arrhythmias.</description>
          <population>Safety success includes 25 subjects that completed follow up and 3 subjects that were Lost To Follow Up</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Death</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Q-wave</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Q-wave myocardial infarction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Target Lesion Revascularization</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cardiac Tamponade</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Life threatening arrhythmias</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Major Adverse Cardiac Events</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TIMI Flow</title>
        <description>To determine post-procedural TIMI Flow grade. Changes of TIMI Grade flow after Index Procedure by measuring pre-procedure TIMI grade flow and post-procedure TIMI grade flow.&#xD;
TIMI flow is a scoring system from 0-3 referring to levels of coronary blood flow assessed during percutaneous coronary angioplasty. TIMI flow was assessed before and after the procedure. TIMI grade flow 0-3 are as described below.&#xD;
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion.&#xD;
TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.&#xD;
TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory.&#xD;
TIMI 3 is normal flow which fills the distal coronary bed completely.</description>
        <time_frame>pre-procedure and post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enrolled</title>
            <description>Enrolled Patients</description>
          </group>
        </group_list>
        <measure>
          <title>TIMI Flow</title>
          <description>To determine post-procedural TIMI Flow grade. Changes of TIMI Grade flow after Index Procedure by measuring pre-procedure TIMI grade flow and post-procedure TIMI grade flow.&#xD;
TIMI flow is a scoring system from 0-3 referring to levels of coronary blood flow assessed during percutaneous coronary angioplasty. TIMI flow was assessed before and after the procedure. TIMI grade flow 0-3 are as described below.&#xD;
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion.&#xD;
TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.&#xD;
TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory.&#xD;
TIMI 3 is normal flow which fills the distal coronary bed completely.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Procedure TIMI grade flow</title>
              <category_list>
                <category>
                  <title>TIMI grade flow 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TIMI grade flow 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TIMI grade flow 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TIMI grade flow 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Procedure TIMI grade flow</title>
              <category_list>
                <category>
                  <title>TIMI grade flow 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TIMI grade flow 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TIMI grade flow 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TIMI grade flow 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity</title>
        <description>Tortuosity from coronary angiography</description>
        <time_frame>Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enrolled</title>
            <description>Enrolled Patients</description>
          </group>
        </group_list>
        <measure>
          <title>Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity</title>
          <description>Tortuosity from coronary angiography</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 45°</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>45° - 90°</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; 90°</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lesion Morphology - Eccentricity of Coronary Lesion</title>
        <description>Eccentricity from coronary angiography as concentric (symmetric) or eccentric (asymmetric)</description>
        <time_frame>Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enrolled</title>
            <description>Enrolled Patients</description>
          </group>
        </group_list>
        <measure>
          <title>Lesion Morphology - Eccentricity of Coronary Lesion</title>
          <description>Eccentricity from coronary angiography as concentric (symmetric) or eccentric (asymmetric)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Concentric lesions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Eccentric lesions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lesion Morphology - Contour as a Lesion Characteristic</title>
        <description>Contour from coronary angiography</description>
        <time_frame>Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enrolled</title>
            <description>Enrolled Patients</description>
          </group>
        </group_list>
        <measure>
          <title>Lesion Morphology - Contour as a Lesion Characteristic</title>
          <description>Contour from coronary angiography</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Irregular Contour</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Smooth Contour</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lesion Morphology - Bifurcation (Branch or Division of Artery)</title>
        <description>Bifurcation from coronary angiography</description>
        <time_frame>Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enrolled</title>
            <description>Enrolled Patients</description>
          </group>
        </group_list>
        <measure>
          <title>Lesion Morphology - Bifurcation (Branch or Division of Artery)</title>
          <description>Bifurcation from coronary angiography</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Bifurcation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Bifurcation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants With Device-related Complications During Procedure</title>
        <description>To determine device related complications</description>
        <time_frame>Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enrolled</title>
            <description>Enrolled Patients</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Device-related Complications During Procedure</title>
          <description>To determine device related complications</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants With Procedure-related Complications During Procedure</title>
        <description>To determine procedure related complications</description>
        <time_frame>Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enrolled</title>
            <description>Enrolled Patients</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Procedure-related Complications During Procedure</title>
          <description>To determine procedure related complications</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected throughout the clinical investigation in the case report form. Any adverse event will be followed until one month follow up visit.</time_frame>
      <desc>Adverse event definition and classification adapted from ISO 14155</desc>
      <group_list>
        <group group_id="E1">
          <title>Enrolled</title>
          <description>Enrolled Patients, including LTFU</description>
        </group>
      </group_list>
      <serious_events>
        <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="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="3" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <description>Stable angina pectoris</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Cardiac troponin I increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </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 NOT 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>Spectranetics Corporation</name_or_title>
      <organization>Spectranetics Corporation</organization>
      <phone>719-447-2211</phone>
      <email>Ami.Sood@philips.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/NCT03284229
org study id: ELCA-1016
nct id: NCT03284229
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This is a Prospective, Open label, Non-randomized, Single-Arm, Multicenter Study to Evaluate
      the Procedural Safety and Efficacy of ELCA® in Treatment of Patients with Single or
      Multivessel Coronary Artery Disease (CAD). Up to 30 patients will be enrolled at up to 05
      Indian study sites. Patients will be followed from enrollment through 30 days ± 7 days for
      the effectiveness and safety endpoints at the study centre.
Each subject will be followed from enrollment through 30 days ± 7 days for the effectiveness
      and safety endpoints. Upon enrollment after obtaining a written informed consent, each
      patient will be assigned a unique identification number. Only patients eligible to undergo
      cardiac catheterizations as per routine practice will be considered for the study.
      Premedication of patients will be as per the investigator's routine practice. All patient
      data will be recorded on patient data forms.

      Screening: This will be performed prior to the cardiac catheterization procedure. Only
      patients who have consented and fulfill the selection criteria will be enrolled.
      Additionally, ECG and Echocardiogram will be done using hospital equipment to ensure
      fulfillment of inclusion/exclusion criteria.

      Procedure: The entire procedure will be carried out as per the site routine practice and the
      device will be used as per the IFU.

      Clinic follow up visit (30 ± 7 days): The subject will return to the clinic at 1 month to
      evaluate angina status as per the CCS classification, AE assessments, concomitant medications
      and any coronary intervention that has occurred since the previous contact.

      An electrocardiogram (ECG) will be repeated during the clinic visit.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: As per the 25th SEC (Cardiovascular & Renal) meeting which deliberated the proposals on 30-10-2015 and recommended the firm (Spectranetics Corporation - Sponsor) shall conduct a Bridging study in Indian Population at least 25 patients with coronary artery disease. The directorate suggested that the sponsor submit a protocol for the study in India for clinical trial approval. Considering the 5 dropouts, Sponsor has set up this protocol to conduct the Excimer Laser Coronary Atherectomy (ELCA®) study in India on 30 eligible patients across 05 sites as a Stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA) in single or multi-vessel coronary artery disease.
primary purpose: Treatment
masking: None (Open Label)
measure: Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion
time frame: Procedure
description: Successful crossing of the Laser Catheter across the entire length of the stenotic lesion
measure: Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure
time frame: Procedure
description: Target lesions with less than 50% residual stenosis after laser and adjunctive therapy.
measure: Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias
time frame: 30 days
description: Freedom from Major Adverse Cardiac Events (MACE) defined as Death, Non-Q-wave and Q-wave myocardial infarction (MI), Target Lesion Revascularization, Cardiac tamponade and life threatening arrhythmias.
measure: TIMI Flow
time frame: pre-procedure and post-procedure
description: To determine post-procedural TIMI Flow grade. Changes of TIMI Grade flow after Index Procedure by measuring pre-procedure TIMI grade flow and post-procedure TIMI grade flow.
TIMI flow is a scoring system from 0-3 referring to levels of coronary blood flow assessed during percutaneous coronary angioplasty. TIMI flow was assessed before and after the procedure. TIMI grade flow 0-3 are as described below.
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion.
TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.
TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory.
TIMI 3 is normal flow which fills the distal coronary bed completely.
measure: Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity
time frame: Procedure
description: Tortuosity from coronary angiography
measure: Lesion Morphology - Eccentricity of Coronary Lesion
time frame: Procedure
description: Eccentricity from coronary angiography as concentric (symmetric) or eccentric (asymmetric)
measure: Lesion Morphology - Contour as a Lesion Characteristic
time frame: Procedure
description: Contour from coronary angiography
measure: Lesion Morphology - Bifurcation (Branch or Division of Artery)
time frame: Procedure
description: Bifurcation from coronary angiography
measure: Participants With Device-related Complications During Procedure
time frame: Procedure
description: To determine device related complications
measure: Participants With Procedure-related Complications During Procedure
time frame: Procedure
description: To determine procedure related complications
arm group label: Excimer Laser Coronary Atherectomy
arm group type: Experimental
description: ELCA® in patients with single or multivessel CAD either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA). The entire procedure will be carried out as per the site routine practice and the device will be used as per the 'Instruction for Use'. Treating physicians/study investigators will be trained by the study Sponsor on the study protocol and procedures prior to clinical investigation procedure. Subject preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted.
intervention type: Device
intervention name: Excimer Laser Coronary Atherectomy
description: Excimer Laser Coronary Atherectomy (ELCA ®) uses the high energy, monochromatic light beam to alter or dissolve (vaporize) the plaque without damaging the surrounding tissue. Fiber-optic catheters are used to deliver this light beam. For endovascular applications, Xenon Chloride excimer laser is used and its fiber-optic catheter has multiple small fibers, rather than just a few large fibers, in order to be flexible enough to navigate in the arterial tree.
arm group label: Excimer Laser Coronary Atherectomy
other name: ELCA Coronary Laser Atherectomy Catheters (OTW and RX)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Karen Krygier, MBA
role: Study Director
affiliation: Spectranetics Corporation
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country: India
url: http://www.spectranetics.com/resources/ifu-library/
description: ELCA laser system and catheter IFUs
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
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