xml: <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/NCT05966662</url>
    </required_header>
    <id_info>
      <org_study_id>CP 68277</org_study_id>
      <nct_id>NCT05966662</nct_id>
    </id_info>
    <brief_title>Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)</brief_title>
    <official_title>Prospective, Multicenter, Single-Arm IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD Duo Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shockwave Medical, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shockwave Medical, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <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>
        This investigational device exemption (IDE) study is to assess the safety and effectiveness&#xD;
        of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz&#xD;
        Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to&#xD;
        stenting.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz&#xD;
        Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation&#xD;
        of severely calcified, stenotic de novo coronary arteries prior to stenting.&#xD;
  &#xD;
        Up to 145 subjects (138 evaluable) subjects with de novo, calcified coronary artery lesions&#xD;
        presenting with stable, unstable, or silent ischemia that are suitable for percutaneous&#xD;
        coronary intervention (PCI) will be enrolled at up to 20 US sites.&#xD;
  &#xD;
        Enrollment duration will be approximately 10-12 months and study duration will be&#xD;
        approximately 2 years.&#xD;
  &#xD;
        Each subject will be followed through discharge, 30 days, 6, and 12 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2024</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>Shockwave C2+ 2Hz Coronary IVL Catheter with Shockwave Intravascular Lithotripsy (IVL) System</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure</measure>
      <time_frame>30 days of the index procedure</time_frame>
      <description>The primary safety endpoint was freedom from MACE within 30 days of the index procedure. MACE is defined as a composite occurrence of: 1) Cardiac death; or 2) Myocardial Infarction (MI) (using the SCAI definition for peri-procedural MI; using the 4th Universal Definition for spontaneous MI beyond discharge); or 3) Target Vessel Revascularization (TVR) defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants With Procedural Success (Residual Stenosis &lt;30%)</measure>
      <time_frame>12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure</time_frame>
      <description>The primary effectiveness endpoint will be evaluated as the following:&#xD;
  Procedural Success defined as stent delivery with a residual stenosis ≤30% (core laboratory assessed) and without in-hospital MACE.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Device Crossing Success</measure>
      <time_frame>at the end of procedure</time_frame>
      <description>Device Crossing Success is defined as the ability to deliver the IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Angiographic Success (Residual Stenosis &lt;50%)</measure>
      <time_frame>at the end of procedure</time_frame>
      <description>Angiographic Success defined as stent delivery with &lt;50% residual stenosis and without serious angiographic complications.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Procedural Success (Residual Stenosis &lt;=30%)</measure>
      <time_frame>12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure]</time_frame>
      <description>Procedural Success defined as stent delivery with a residual stenosis &lt;50% (core laboratory assessed) and without in-hospital MACE.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Angiographic Success (Residual Stenosis &lt;=30%)</measure>
      <time_frame>at end of procedure</time_frame>
      <description>Angiographic Success defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Serious Angiographic Complications</measure>
      <time_frame>at end of procedure</time_frame>
      <description>Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MACE Rate at 6 Months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>MACE at 6 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MACE Rate at 12 Months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>MACE at 12 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Target Lesion Failure (TLF) Rate at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>Target lesion failure (TLF) is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. 30 day rates are presented as proportions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Target Lesion Failure (TLF) Rate at 6 Months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 6 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Target Lesion Failure (TLF) Rate at 12 Months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 12 months, rates are presented as Kaplan-Meier estimated event rates</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-Cause Death Rate at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>30-day rates are presented as proportions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-Cause Death Rate at 6 Months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>All-cause death at 6 months is presented as a Kaplan-Meier estimated event rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-Cause Death Rate at 12 Months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>All-cause death at 12 months is presented as a Kaplan-Meier estimated event rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiac Death Rate at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>30-day rates are presented as proportions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiac Death Rate at 6 Months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>Cardiac death at 6 months is presented as a Kaplan-Meier estimated event rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiac Death Rate at 12 Months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>Cardiac death at 12 months is presented as a Kaplan-Meier estimated event rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MI Rate at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>30-day rates are presented as proportions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MI Rate at 6 Months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>MI is presented as a Kaplan-Meier estimated event rate at 6 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MI Rate at 12 Months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>MI is presented as a Kaplan-Meier estimated event rate at 12 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Target Vessel-Myocardial Infarction (TV-MI) Rate at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>30-day rates are presented as proportions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TV-MI Rate at 6 Months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>TV-MI is presented as a Kaplan-Meier estimated event rate at 6 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TV-MI Rate at 12 Months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>TV-MI is presented as a Kaplan-Meier estimated event rate at 12 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Procedural MI Rate at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>Periprocedural MI defined as fourth universal definition and CK-MB &gt; 3x upper limit of lab normal (ULN). 30-day rates are presented as proportions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Procedural MI Rate at 6 Months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>Periprocedural MI defined as fourth universal definition and CK-MB &gt; 3x upper limit of lab normal (ULN). For 6 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Procedural MI Rate at 12 Months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>Periprocedural MI defined as fourth universal definition and CK-MB &gt; 3x upper limit of lab normal (ULN). For 12 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-Procedural MI Rate at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). 30-day rates are presented as proportions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-Procedural MI Rate at 6 Months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 6 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-Procedural MI Rate at 12 Months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 12 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ischemia-Driven Target Vessel Revascularization (ID-TVR) Rate at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>30-day rates are presented as proportions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ID-TVR Rate at 6 Months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>For 6 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ID-TVR Rate at 12 Month</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>For 12 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>30-day rates are presented as proportions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ID-TLR Rate at 6 Months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>For 6 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ID-TLR Rate at 12 Months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>For 12 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-ID-TVR Rate at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>30-day rates are presented as proportions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-ID-TVR Rate at 6 Months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>For 6 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-ID-TVR Rate at 12 Months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>For 12 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-ID-TLR Rate at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>30-day rates are presented as proportions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-ID-TLR Rate at 6 Months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>For 6 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-ID-TLR Rate at 12 Months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>For 12 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Any Revascularizations Rate at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>Any revascularizations (ID and non-ID) at 30 days. 30-day rates are presented as proportions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Any Revascularizations Rate at 6 months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>Any revascularizations (ID and non-ID) at 6 months, presented as a Kaplan-Meier estimated event rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Any Revascularizations Rate at 12 months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>Any revascularizations (ID and non-ID) at 12 months, presented as a Kaplan-Meier estimated event rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stent Thrombosis Rate at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. 30-day rates are presented as proportions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stent Thrombosis Rate at 6 Months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 6 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stent Thrombosis Rate at 12 Months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 12 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of MI Using the 4th Universal Definition at 30 Days</measure>
      <time_frame>within 30 days of index procedure</time_frame>
      <description>30-day rates are presented as proportions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of MI Using the 4th Universal Definition at 6 months</measure>
      <time_frame>within 6 months of index procedure</time_frame>
      <description>For 6 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of MI Using the 4th Universal Definition at 12 months</measure>
      <time_frame>within 12 months of index procedure</time_frame>
      <description>For 12 months, rates are presented as Kaplan-Meier estimated event rates.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">145</enrollment>
    <condition>Coronary Artery Disease</condition>
    <condition>Myocardial Infarction</condition>
    <arm_group>
      <arm_group_label>Single-Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects with de novo, calcified coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>IVL with Shockwave C2+ 2Hz Coronary IVL Catheter</intervention_name>
      <description>Lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.</description>
      <arm_group_label>Single-Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:Subjects are required to meet all of the following inclusion criteria in&#xD;
          order to be enrolled in the clinical study.&#xD;
  &#xD;
          General Inclusion Criteria&#xD;
  &#xD;
            1. Subject is ≥18 years of age&#xD;
  &#xD;
            2. Subjects with native coronary artery disease (including stable or unstable angina and&#xD;
               silent ischemia) suitable for PCI&#xD;
  &#xD;
            3. For subjects with unstable ischemic heart disease, biomarkers (CK-MB and troponin)&#xD;
               must be less than or equal to the upper limit of the laboratory normal within 12 hours&#xD;
               prior to the procedure (note: both must be normal)&#xD;
  &#xD;
            4. For subjects with stable ischemic heart disease, biomarkers may be drawn prior to the&#xD;
               procedure or at the time of the procedure from the side port of the sheath&#xD;
  &#xD;
                 1. If drawn prior to the procedure, biomarkers (CK-MB and troponin) must be less&#xD;
                    than or equal to the upper limit of the laboratory normal within 12 hours of the&#xD;
                    procedure (note: both must be normal)&#xD;
  &#xD;
                 2. If drawn at the time of the procedure from the side port of the sheath prior to&#xD;
                    any intervention, biomarker results do not need to be analyzed prior to&#xD;
                    enrollment&#xD;
  &#xD;
            5. Left ventricular ejection fraction &gt;25% within 6 months (note: in the case of multiple&#xD;
               assessments of LVEF, the measurement closest to enrollment will be used for this&#xD;
               criterion; may be assessed at time of index procedure)&#xD;
  &#xD;
            6. Subject or legally authorized representative, signs a written Informed Consent form to&#xD;
               participate in the study, prior to any study-mandated procedures&#xD;
  &#xD;
            7. Non-target lesions requiring PCI may be treated either&#xD;
  &#xD;
                 1. &gt;30 days prior to the study procedure if the procedure was unsuccessful or&#xD;
                    complicated; or&#xD;
  &#xD;
                 2. &gt;24 hours prior to the study procedure if the procedure was successful and&#xD;
                    uncomplicated (defined as a final lesion angiographic diameter stenosis &lt;30% and&#xD;
                    TIMI 3 flow (visually assessed) for all non-target lesions and vessels without&#xD;
                    perforation, cardiac arrest or need for defibrillation or cardioversion or&#xD;
                    hypotension/heart failure requiring mechanical or intravenous hemodynamic support&#xD;
                    or intubation, and with no post-procedure biomarker elevation &gt;normal; or&#xD;
  &#xD;
                 3. &gt;30 days after the study procedure&#xD;
  &#xD;
               Angiographic Inclusion Criteria&#xD;
  &#xD;
            8. The target lesion must be a de novo coronary lesion that has not been previously&#xD;
               treated with any interventional procedure&#xD;
  &#xD;
            9. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of&#xD;
               their branches) with&#xD;
  &#xD;
                 1. Stenosis of ≥70% and &lt;100%, or&#xD;
  &#xD;
                 2. Stenosis ≥50% and &lt;70% (visually assessed) with evidence of ischemia via positive&#xD;
                    stress test, or fractional flow reserve value ≤0.80, or iFR &lt;0.90 or IVUS or OCT&#xD;
                    minimum lumen area ≤4.0 mm2&#xD;
  &#xD;
           10. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm&#xD;
  &#xD;
           11. The lesion length must not exceed 40 mm&#xD;
  &#xD;
           12. The target vessel must have TIMI flow 3 at baseline (visually assessed; may be&#xD;
               assessed after pre- dilatation)&#xD;
  &#xD;
           13. Evidence of calcification at the lesion site by, a) angiography, with fluoroscopic&#xD;
               radio-opacities noted without cardiac motion prior to contrast injection involving&#xD;
               both sides of the arterial wall in at least one location and total length of calcium&#xD;
               of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or&#xD;
               OCT, with presence of ≥270 degrees of calcium on at least 1 cross section&#xD;
  &#xD;
           14. Ability to pass a 0.014&quot; guide wire across the lesion&#xD;
  &#xD;
          Exclusion Criteria: Subjects who meet any of the following exclusion criteria may not be&#xD;
          enrolled in the study:&#xD;
  &#xD;
          General Exclusion Criteria&#xD;
  &#xD;
            1. Any comorbidity or condition which may reduce compliance with this protocol, including&#xD;
               follow-up visits&#xD;
  &#xD;
            2. Subject is participating in another research study involving an investigational agent&#xD;
               (pharmaceutical, biologic, or medical device) that has not reached the primary&#xD;
               endpoint&#xD;
  &#xD;
            3. Subject is pregnant or nursing (a negative pregnancy test is required for women of&#xD;
               child-bearing potential within 7 days prior to enrollment)&#xD;
  &#xD;
            4. Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines&#xD;
  &#xD;
            5. Subject has an allergy to imaging contrast media which cannot be adequately&#xD;
               pre-medicated&#xD;
  &#xD;
            6. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index&#xD;
               procedure, defined as a clinical syndrome consistent with an acute coronary syndrome&#xD;
               with troponin greater than 1 times the local laboratory's upper limit of normal&#xD;
  &#xD;
            7. New York Heart Association (NYHA) class III or IV heart failure&#xD;
  &#xD;
            8. Subject has acute or chronic renal disease with eGFR &lt;30 ml/min/1.73m2 (using CKD-EPI&#xD;
               formula)&#xD;
  &#xD;
            9. History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior&#xD;
               intracranial hemorrhage or permanent neurologic deficit&#xD;
  &#xD;
           10. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months&#xD;
  &#xD;
           11. Untreated pre-procedural hemoglobin &lt;10 g/dL or intention to refuse blood transfusions&#xD;
               if one should become necessary&#xD;
  &#xD;
           12. Coagulopathy, including but not limited to platelet count &lt;100,000 or International&#xD;
               Normalized ratio (INR) &gt; 1.7 (INR is only required in subjects who have taken warfarin&#xD;
               within 2 weeks of enrollment)&#xD;
  &#xD;
           13. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count&#xD;
               &gt;750,000 or other related blood disorders&#xD;
  &#xD;
           14. Subject has an active systemic infection on the day of the index procedure with either&#xD;
               fever, leukocytosis or requiring intravenous antibiotics&#xD;
  &#xD;
           15. Subjects with clinical evidence of cardiogenic shock&#xD;
  &#xD;
           16. Uncontrolled severe hypertension (systolic BP &gt;180 mm Hg or diastolic BP &gt;110 mm Hg)&#xD;
  &#xD;
           17. Subjects with a life expectancy of less than 1 year&#xD;
  &#xD;
           18. Non-coronary interventional or surgical structural heart procedures (e.g., TAVR,&#xD;
               MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure&#xD;
  &#xD;
           19. Planned non-coronary interventional or surgical structural heart procedures (e.g.,&#xD;
               TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure&#xD;
  &#xD;
           20. Subject refusing or not a candidate for emergency coronary artery bypass grafting&#xD;
               (CABG) surgery&#xD;
  &#xD;
           21. Planned use of atherectomy, scoring or cutting balloon, or any investigational device&#xD;
               other than lithotripsy&#xD;
  &#xD;
               Angiographic Exclusion Criteria&#xD;
  &#xD;
           22. Unprotected left main diameter stenosis &gt;30%&#xD;
  &#xD;
           23. Definite or possible thrombus (by angiography or intravascular imaging) in the target&#xD;
               vessel&#xD;
  &#xD;
           24. Evidence of aneurysm in target vessel within 10 mm of the target lesion&#xD;
  &#xD;
           25. Target lesion is located in a native vessel that can only be reached by going through&#xD;
               a saphenous vein or arterial bypass graft&#xD;
  &#xD;
           26. Previous stent within 5 mm of the target lesion regardless of the timing of its&#xD;
               implantation&#xD;
  &#xD;
           27. Angiographic evidence of a dissection or perforation in the target vessel at baseline&#xD;
               or after guidewire passage&#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_contact>
      <last_name>Randee Randoll</last_name>
      <phone>1.408.577.7856</phone>
      <email>rrandoll@shockwavemedical.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Intravasular Lithotripsy</keyword>
    <keyword>PCI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Infarction</mesh_term>
      <mesh_term>Infarction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966662
  org study id: CP 68277
  nct id: NCT05966662
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  This investigational device exemption (IDE) study is to assess the safety and effectiveness
        of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz
        Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to
        stenting.
  The Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz
        Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation
        of severely calcified, stenotic de novo coronary arteries prior to stenting.
  
        Up to 145 subjects (138 evaluable) subjects with de novo, calcified coronary artery lesions
        presenting with stable, unstable, or silent ischemia that are suitable for percutaneous
        coronary intervention (PCI) will be enrolled at up to 20 US sites.
  
        Enrollment duration will be approximately 10-12 months and study duration will be
        approximately 2 years.
  
        Each subject will be followed through discharge, 30 days, 6, and 12 months.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Shockwave C2+ 2Hz Coronary IVL Catheter with Shockwave Intravascular Lithotripsy (IVL) System
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure
  time frame: 30 days of the index procedure
  description: The primary safety endpoint was freedom from MACE within 30 days of the index procedure. MACE is defined as a composite occurrence of: 1) Cardiac death; or 2) Myocardial Infarction (MI) (using the SCAI definition for peri-procedural MI; using the 4th Universal Definition for spontaneous MI beyond discharge); or 3) Target Vessel Revascularization (TVR) defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
  measure: Number of Participants With Procedural Success (Residual Stenosis <30%)
  time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
  description: The primary effectiveness endpoint will be evaluated as the following:
  Procedural Success defined as stent delivery with a residual stenosis ≤30% (core laboratory assessed) and without in-hospital MACE.
  measure: Number of Participants with Device Crossing Success
  time frame: at the end of procedure
  description: Device Crossing Success is defined as the ability to deliver the IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL.
  measure: Number of Participants With Angiographic Success (Residual Stenosis <50%)
  time frame: at the end of procedure
  description: Angiographic Success defined as stent delivery with <50% residual stenosis and without serious angiographic complications.
  measure: Number of Participants With Procedural Success (Residual Stenosis <=30%)
  time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure]
  description: Procedural Success defined as stent delivery with a residual stenosis <50% (core laboratory assessed) and without in-hospital MACE.
  measure: Number of Participants With Angiographic Success (Residual Stenosis <=30%)
  time frame: at end of procedure
  description: Angiographic Success defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications.
  measure: Number of Participants With Serious Angiographic Complications
  time frame: at end of procedure
  description: Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
  measure: MACE Rate at 6 Months
  time frame: within 6 months of index procedure
  description: MACE at 6 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate.
  measure: MACE Rate at 12 Months
  time frame: within 12 months of index procedure
  description: MACE at 12 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate.
  measure: Target Lesion Failure (TLF) Rate at 30 Days
  time frame: within 30 days of index procedure
  description: Target lesion failure (TLF) is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. 30 day rates are presented as proportions.
  measure: Target Lesion Failure (TLF) Rate at 6 Months
  time frame: within 6 months of index procedure
  description: TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 6 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Target Lesion Failure (TLF) Rate at 12 Months
  time frame: within 12 months of index procedure
  description: TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 12 months, rates are presented as Kaplan-Meier estimated event rates
  measure: All-Cause Death Rate at 30 Days
  time frame: within 30 days of index procedure
  description: 30-day rates are presented as proportions.
  measure: All-Cause Death Rate at 6 Months
  time frame: within 6 months of index procedure
  description: All-cause death at 6 months is presented as a Kaplan-Meier estimated event rate.
  measure: All-Cause Death Rate at 12 Months
  time frame: within 12 months of index procedure
  description: All-cause death at 12 months is presented as a Kaplan-Meier estimated event rate.
  measure: Cardiac Death Rate at 30 Days
  time frame: within 30 days of index procedure
  description: 30-day rates are presented as proportions
  measure: Cardiac Death Rate at 6 Months
  time frame: within 6 months of index procedure
  description: Cardiac death at 6 months is presented as a Kaplan-Meier estimated event rate.
  measure: Cardiac Death Rate at 12 Months
  time frame: within 12 months of index procedure
  description: Cardiac death at 12 months is presented as a Kaplan-Meier estimated event rate.
  measure: MI Rate at 30 Days
  time frame: within 30 days of index procedure
  description: 30-day rates are presented as proportions.
  measure: MI Rate at 6 Months
  time frame: within 6 months of index procedure
  description: MI is presented as a Kaplan-Meier estimated event rate at 6 months.
  measure: MI Rate at 12 Months
  time frame: within 12 months of index procedure
  description: MI is presented as a Kaplan-Meier estimated event rate at 12 months.
  measure: Target Vessel-Myocardial Infarction (TV-MI) Rate at 30 Days
  time frame: within 30 days of index procedure
  description: 30-day rates are presented as proportions.
  measure: TV-MI Rate at 6 Months
  time frame: within 6 months of index procedure
  description: TV-MI is presented as a Kaplan-Meier estimated event rate at 6 months.
  measure: TV-MI Rate at 12 Months
  time frame: within 12 months of index procedure
  description: TV-MI is presented as a Kaplan-Meier estimated event rate at 12 months.
  measure: Procedural MI Rate at 30 Days
  time frame: within 30 days of index procedure
  description: Periprocedural MI defined as fourth universal definition and CK-MB > 3x upper limit of lab normal (ULN). 30-day rates are presented as proportions.
  measure: Procedural MI Rate at 6 Months
  time frame: within 6 months of index procedure
  description: Periprocedural MI defined as fourth universal definition and CK-MB > 3x upper limit of lab normal (ULN). For 6 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Procedural MI Rate at 12 Months
  time frame: within 12 months of index procedure
  description: Periprocedural MI defined as fourth universal definition and CK-MB > 3x upper limit of lab normal (ULN). For 12 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Non-Procedural MI Rate at 30 Days
  time frame: within 30 days of index procedure
  description: Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). 30-day rates are presented as proportions.
  measure: Non-Procedural MI Rate at 6 Months
  time frame: within 6 months of index procedure
  description: Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 6 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Non-Procedural MI Rate at 12 Months
  time frame: within 12 months of index procedure
  description: Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 12 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Ischemia-Driven Target Vessel Revascularization (ID-TVR) Rate at 30 Days
  time frame: within 30 days of index procedure
  description: 30-day rates are presented as proportions.
  measure: ID-TVR Rate at 6 Months
  time frame: within 6 months of index procedure
  description: For 6 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: ID-TVR Rate at 12 Month
  time frame: within 12 months of index procedure
  description: For 12 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days
  time frame: within 30 days of index procedure
  description: 30-day rates are presented as proportions.
  measure: ID-TLR Rate at 6 Months
  time frame: within 6 months of index procedure
  description: For 6 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: ID-TLR Rate at 12 Months
  time frame: within 12 months of index procedure
  description: For 12 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Non-ID-TVR Rate at 30 Days
  time frame: within 30 days of index procedure
  description: 30-day rates are presented as proportions
  measure: Non-ID-TVR Rate at 6 Months
  time frame: within 6 months of index procedure
  description: For 6 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Non-ID-TVR Rate at 12 Months
  time frame: within 12 months of index procedure
  description: For 12 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Non-ID-TLR Rate at 30 Days
  time frame: within 30 days of index procedure
  description: 30-day rates are presented as proportions
  measure: Non-ID-TLR Rate at 6 Months
  time frame: within 6 months of index procedure
  description: For 6 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Non-ID-TLR Rate at 12 Months
  time frame: within 12 months of index procedure
  description: For 12 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Any Revascularizations Rate at 30 Days
  time frame: within 30 days of index procedure
  description: Any revascularizations (ID and non-ID) at 30 days. 30-day rates are presented as proportions.
  measure: Any Revascularizations Rate at 6 months
  time frame: within 6 months of index procedure
  description: Any revascularizations (ID and non-ID) at 6 months, presented as a Kaplan-Meier estimated event rate.
  measure: Any Revascularizations Rate at 12 months
  time frame: within 12 months of index procedure
  description: Any revascularizations (ID and non-ID) at 12 months, presented as a Kaplan-Meier estimated event rate
  measure: Stent Thrombosis Rate at 30 Days
  time frame: within 30 days of index procedure
  description: Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. 30-day rates are presented as proportions.
  measure: Stent Thrombosis Rate at 6 Months
  time frame: within 6 months of index procedure
  description: Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 6 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Stent Thrombosis Rate at 12 Months
  time frame: within 12 months of index procedure
  description: Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 12 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Rate of MI Using the 4th Universal Definition at 30 Days
  time frame: within 30 days of index procedure
  description: 30-day rates are presented as proportions.
  measure: Rate of MI Using the 4th Universal Definition at 6 months
  time frame: within 6 months of index procedure
  description: For 6 months, rates are presented as Kaplan-Meier estimated event rates.
  measure: Rate of MI Using the 4th Universal Definition at 12 months
  time frame: within 12 months of index procedure
  description: For 12 months, rates are presented as Kaplan-Meier estimated event rates.
  arm group label: Single-Arm
  arm group type: Experimental
  description: Subjects with de novo, calcified coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI).
  intervention type: Device
  intervention name: IVL with Shockwave C2+ 2Hz Coronary IVL Catheter
  description: Lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.
  arm group label: Single-Arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Randee Randoll
  phone: 1.408.577.7856
  email: rrandoll@shockwavemedical.com
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Infarction
  mesh term: Infarction
  sharing ipd: No