<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/NCT02195414</url>
  </required_header>
  <id_info>
    <org_study_id>LPM-201401</org_study_id>
    <nct_id>NCT02195414</nct_id>
  </id_info>
  <brief_title>NeoVas Bioresorbable Coronary Scaffold First-in-Man Study</brief_title>
  <official_title>Clinical Evaluation of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients With de Novo Coronary Artery Lesion (NeoVas): a First-in-Man Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lepu Medical Technology (Beijing) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lepu Medical Technology (Beijing) Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will&#xD;
      enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical&#xD;
      feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold&#xD;
      in the treatment of patients with de novo coronary lesion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary endpoint is a composite endpoint of cardiac death, target vessel related&#xD;
      myocardial infarction, and ischemia driven target lesion revascularization (TLF) at 1 month&#xD;
      follow up. At 6 months, 1, 2, 3, 4 and 5 years follow-up, clinical endpoints include TLF (its&#xD;
      individual components), Patient-oriented cardiac event (all cause death, all MI, and all&#xD;
      revascularization) target vessel revascularization, scaffold thrombosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Target Lesion Failure(TLF)</measure>
    <time_frame>30 days</time_frame>
    <description>Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Failure</measure>
    <time_frame>6 months</time_frame>
    <description>Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Failure</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Failure</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Failure</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Failure</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Failure</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Oriented Composite Endpoint</measure>
    <time_frame>30 days</time_frame>
    <description>Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Oriented Composite Endpoint</measure>
    <time_frame>6 months</time_frame>
    <description>Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Oriented Composite Endpoint</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Oriented Composite Endpoint</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Oriented Composite Endpoint</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Oriented Composite Endpoint</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Oriented Composite Endpoint</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Success (Clinical Device and Clinical Procedure)</measure>
    <time_frame>acute</time_frame>
    <description>Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable).&#xD;
Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In dual lesion setting both lesions must meet clinical procedure success.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scaffold Thrombosis</measure>
    <time_frame>30days</time_frame>
    <description>Scaffold thrombosis will be categorized as acute (≤1day), subacute (&gt;1day ≤30 days) and late (&gt;30 days).&#xD;
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion).&#xD;
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the targetlesion within 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scaffold Thrombosis</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scaffold Thrombosis</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scaffold Thrombosis</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scaffold Thrombosis</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scaffold Thrombosis</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scaffold Thrombosis</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic Endpoint</measure>
    <time_frame>6 months</time_frame>
    <description>In-segment In-scaffold, proximal and distal Late lumen loss (mm); In-segment In-scaffold, proximal and distal Minimal lumen diameter(mm); In-segment In-scaffold, proximal and distal Diameter stenosis (%) Angiographic Binary Restenosis (%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic Endpoint</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic Endpoint</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OCT Endpoint</measure>
    <time_frame>6 months</time_frame>
    <description>proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OCT Endpoint</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OCT Endpoint</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IVUS Endpoint</measure>
    <time_frame>6 months</time_frame>
    <description>mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IVUS Endpoint</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IVUS Endpoint</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MSCT Endpoint</measure>
    <time_frame>1 year</time_frame>
    <description>mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MSCT Endpoint</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>NeoVas BCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The NeoVas sirolimus-eluting bioresorbable coronary scaffold system is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NeoVas BCS</intervention_name>
    <description>The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and ischemia driven target lesion revascularization (TLF) at 1 month follow up. At 6 months, 1, 2, 3, 4 and 5 years follow-up, clinical endpoints include TLF (its individual components), Patient-oriented cardiac event (all cause death, all MI, and all revascularization) target vessel revascularization, scaffold thrombosis.</description>
    <arm_group_label>NeoVas BCS</arm_group_label>
    <other_name>NeoVas bioresorbable coronary scaffold</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age must be between 18 and 75 years, men or unpregnant women&#xD;
&#xD;
          -  Patient must have evidence of myocardial ischemia (e.g., stable angina, unstable&#xD;
             angina)&#xD;
&#xD;
          -  Total number of target lesion =1 per patient&#xD;
&#xD;
          -  Target lesion must be ≤ 20mm in length (visual estimation) and 2.75 to 3.75 mm in&#xD;
             diameter（Online QCA）&#xD;
&#xD;
          -  Target lesion is with a visually estimated stenosis of ≥ 70% (or ≥50% and evidence of&#xD;
             myocardial ischemia) with a TIMI flow of ≥ 1&#xD;
&#xD;
          -  The target lesion can be covered by one scaffold&#xD;
&#xD;
          -  Patient must be an acceptable candidate for coronary artery bypass graft.&#xD;
&#xD;
          -  Patient is able to verbally confirm understanding of risks, benefits and treatment of&#xD;
             receiving the NeoVas bioresorbable coronary scaffold and he/she or his/her legally&#xD;
             authorized representative provides written informed consent prior to any clinical&#xD;
             investigation related procedure, as approved by the appropriate Ethics Committee of&#xD;
             the respective clinical site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients has had a known diagnosis of acute myocardial infarction (AMI) within 30 days&#xD;
             preceding the procedure; CK and CK-MB have not returned within normal limits at the&#xD;
             time of procedure&#xD;
&#xD;
          -  Chronic total occlusion lesions(TIMI 0 grade blood flow prior to implantation), left&#xD;
             trunk vessel lesion, ostial lesion ,multi-branch lesions needing treated, fork and&#xD;
             bridge vessel lesions of branch vessels whose diameter ≥2.0mm(branch opening stenosis&#xD;
             exceeds 40% or need balloon expansion); there is thrombus visible in the target blood&#xD;
             vessels.&#xD;
&#xD;
          -  Severe calcified lesions and twisted lesions which cannot be pre-expanded, and lesions&#xD;
             unsuitable for delivering and expanding stents&#xD;
&#xD;
          -  In-stent restenosis lesion&#xD;
&#xD;
          -  Patient has undergone previous stenting anywhere within the target vessel(s) within&#xD;
             the previous 12 months, or will require stenting within the target vessel(s) within 6&#xD;
             months after the study procedure; target vessels that has been planted stents over a&#xD;
             year.&#xD;
&#xD;
          -  Severe heart failure(over NYHA III grade ), or left ventricular ejection&#xD;
             fraction(LVEF)&lt; 40%( supersonic inspection or left ventricular radiography )&#xD;
&#xD;
          -  Known renal insufficiency (e.g., eGFR &lt;60 ml/min, or subject on dialysis)&#xD;
&#xD;
          -  Patients with hemorrhage tendency, an active digestive ulcer history, a cerebral&#xD;
             hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a&#xD;
             year, and these patients who contraindicate against platelet inhibitors and&#xD;
             anticoagulant therefore can not bear anticoagulation treatment&#xD;
&#xD;
          -  Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel,&#xD;
             heparin, contrast agent, polylactic acid or sirolimus that cannot be adequately&#xD;
             pre-medicated&#xD;
&#xD;
          -  Life expectancy &lt; 12 months&#xD;
&#xD;
          -  Patient is participating in another device or drug study that has not reached the&#xD;
             primary endpoint of the study.&#xD;
&#xD;
          -  Patient's inability to fully cooperate with the study protocol which in the&#xD;
             investigator's opinion may limit his/her ability to participate in the study&#xD;
&#xD;
          -  Patient has a heart transplant.&#xD;
&#xD;
          -  Patient has current unstable arrhythmias, such as high risk ventricular premature beat&#xD;
             and ventricular tachycardia.&#xD;
&#xD;
          -  Patient is receiving or scheduled to receive chemotherapy for malignancy within 30&#xD;
             days prior to or after the procedure&#xD;
&#xD;
          -  Patient is receiving immunosuppression therapy and has known immunosuppressive or&#xD;
             autoimmune disease&#xD;
&#xD;
          -  Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g.,&#xD;
             heparin, coumadin)&#xD;
&#xD;
          -  Elective surgery is planned within the first 6 months after the procedure that will&#xD;
             require discontinuing either aspirin or clopidogrel&#xD;
&#xD;
          -  Platelet count &lt;100,000 cells/mm3 or &gt;700,000 cells/mm3, a WBC of &lt;3,000 cells/mm3, or&#xD;
             documented or suspected liver disease (including laboratory evidence of hepatitis)&#xD;
&#xD;
          -  Patient has extensive peripheral vascular disease that precludes safe 6 French sheath&#xD;
             insertion&#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>Yaling Han, MD</last_name>
    <role>Study Chair</role>
    <affiliation>The general hospital of Shenyang military region</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guosheng Fu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sir Run Run Shaw Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bo Xu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Fuwai hospital, National center for cardiovascular diseases China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yao-Jun Zhang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanjing First Hospital, Nanjing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The General Hospital of Shenyang Military Region</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110015</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <results_first_submitted>December 23, 2014</results_first_submitted>
  <results_first_submitted_qc>February 16, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 14, 2016</results_first_posted>
  <last_update_submitted>March 11, 2016</last_update_submitted>
  <last_update_submitted_qc>March 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NeoVas</keyword>
  <keyword>Bioresorbable scaffold</keyword>
  <keyword>Sirolimus</keyword>
  <keyword>First-in-Man</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects enrolled into this trial were comprised of male and female subjects from the general interventional cardiology population. The study commenced on June 19, 2014 with the first subject enrolled on this date. The last subject was enrolled September 3, 2014.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>NeoVas BCS</title>
          <description>Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Primary Endpoint</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>NeoVas BCS</title>
          <description>Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="31"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age must be between 18 and 75 years.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.1" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Mellitus</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Angina Categories</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Stable angina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unstable angina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NSTEMI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Target vessel location</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Left anterior descending artery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left circumflex artery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right coronary artery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stent diameter</title>
          <units>millimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.35" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stent length</title>
          <units>millimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.35" spread="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Target Lesion Failure(TLF)</title>
        <description>Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NeoVas BCS</title>
            <description>Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.</description>
          </group>
        </group_list>
        <measure>
          <title>Target Lesion Failure(TLF)</title>
          <description>Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Failure</title>
        <description>Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.</description>
        <time_frame>6 months</time_frame>
        <posting_date>04/2016</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Failure</title>
        <time_frame>1 year</time_frame>
        <posting_date>10/2016</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Failure</title>
        <time_frame>2 years</time_frame>
        <posting_date>10/2017</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Failure</title>
        <time_frame>3 years</time_frame>
        <posting_date>10/2018</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Failure</title>
        <time_frame>4 years</time_frame>
        <posting_date>10/2019</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Failure</title>
        <time_frame>5 years</time_frame>
        <posting_date>10/2020</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Oriented Composite Endpoint</title>
        <description>Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NeoVas BCS</title>
            <description>Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Oriented Composite Endpoint</title>
          <description>Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Oriented Composite Endpoint</title>
        <description>Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.</description>
        <time_frame>6 months</time_frame>
        <posting_date>04/2016</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Oriented Composite Endpoint</title>
        <time_frame>1 year</time_frame>
        <posting_date>10/2016</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Oriented Composite Endpoint</title>
        <time_frame>2 years</time_frame>
        <posting_date>10/2016</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Oriented Composite Endpoint</title>
        <time_frame>3 years</time_frame>
        <posting_date>10/2017</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Oriented Composite Endpoint</title>
        <time_frame>4 years</time_frame>
        <posting_date>10/2018</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Oriented Composite Endpoint</title>
        <time_frame>5 years</time_frame>
        <posting_date>10/2019</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acute Success (Clinical Device and Clinical Procedure)</title>
        <description>Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable).&#xD;
Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In dual lesion setting both lesions must meet clinical procedure success.</description>
        <time_frame>acute</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NeoVas BCS</title>
            <description>Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Success (Clinical Device and Clinical Procedure)</title>
          <description>Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable).&#xD;
Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In dual lesion setting both lesions must meet clinical procedure success.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Success</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Scaffold Thrombosis</title>
        <description>Scaffold thrombosis will be categorized as acute (≤1day), subacute (&gt;1day ≤30 days) and late (&gt;30 days).&#xD;
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion).&#xD;
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the targetlesion within 30 days.</description>
        <time_frame>30days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NeoVas BCS</title>
            <description>Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.</description>
          </group>
        </group_list>
        <measure>
          <title>Scaffold Thrombosis</title>
          <description>Scaffold thrombosis will be categorized as acute (≤1day), subacute (&gt;1day ≤30 days) and late (&gt;30 days).&#xD;
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion).&#xD;
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the targetlesion within 30 days.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Scaffold Thrombosis</title>
        <time_frame>6 months</time_frame>
        <posting_date>04/2016</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Scaffold Thrombosis</title>
        <time_frame>1 year</time_frame>
        <posting_date>10/2016</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Scaffold Thrombosis</title>
        <time_frame>2 years</time_frame>
        <posting_date>10/2017</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Scaffold Thrombosis</title>
        <time_frame>3 years</time_frame>
        <posting_date>10/2018</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Scaffold Thrombosis</title>
        <time_frame>4 years</time_frame>
        <posting_date>10/2019</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Scaffold Thrombosis</title>
        <time_frame>5 years</time_frame>
        <posting_date>10/2020</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Angiographic Endpoint</title>
        <description>In-segment In-scaffold, proximal and distal Late lumen loss (mm); In-segment In-scaffold, proximal and distal Minimal lumen diameter(mm); In-segment In-scaffold, proximal and distal Diameter stenosis (%) Angiographic Binary Restenosis (%).</description>
        <time_frame>6 months</time_frame>
        <posting_date>04/2016</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Angiographic Endpoint</title>
        <time_frame>2 years</time_frame>
        <posting_date>10/2016</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Angiographic Endpoint</title>
        <time_frame>5 years</time_frame>
        <posting_date>10/2020</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>OCT Endpoint</title>
        <description>proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction.</description>
        <time_frame>6 months</time_frame>
        <posting_date>04/2016</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>OCT Endpoint</title>
        <time_frame>2 years</time_frame>
        <posting_date>10/2017</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>OCT Endpoint</title>
        <time_frame>5 years</time_frame>
        <posting_date>10/2020</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IVUS Endpoint</title>
        <description>mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area</description>
        <time_frame>6 months</time_frame>
        <posting_date>04/2016</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IVUS Endpoint</title>
        <time_frame>2 years</time_frame>
        <posting_date>10/2017</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IVUS Endpoint</title>
        <time_frame>5 years</time_frame>
        <posting_date>10/2020</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MSCT Endpoint</title>
        <description>mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area</description>
        <time_frame>1 year</time_frame>
        <posting_date>10/2016</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MSCT Endpoint</title>
        <time_frame>3 years</time_frame>
        <posting_date>10/2018</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>NeoVas BCS</title>
          <description>Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
              </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>Yaling Han, Study Chair of Clinical Trials</name_or_title>
      <organization>The General Hospital of Shenyang Military Region</organization>
      <phone>+86-024-28856123</phone>
      <email>hanyaling@263.net</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/NCT02195414
org study id: LPM-201401
nct id: NCT02195414
lead sponsor: 
has dmc: Yes
The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will
      enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical
      feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold
      in the treatment of patients with de novo coronary lesion.
The primary endpoint is a composite endpoint of cardiac death, target vessel related
      myocardial infarction, and ischemia driven target lesion revascularization (TLF) at 1 month
      follow up. At 6 months, 1, 2, 3, 4 and 5 years follow-up, clinical endpoints include TLF (its
      individual components), Patient-oriented cardiac event (all cause death, all MI, and all
      revascularization) target vessel revascularization, scaffold thrombosis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Target Lesion Failure(TLF)
time frame: 30 days
description: Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.
measure: Target Lesion Failure
time frame: 6 months
description: Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.
measure: Target Lesion Failure
time frame: 1 year
measure: Target Lesion Failure
time frame: 2 years
measure: Target Lesion Failure
time frame: 3 years
measure: Target Lesion Failure
time frame: 4 years
measure: Target Lesion Failure
time frame: 5 years
measure: Patient Oriented Composite Endpoint
time frame: 30 days
description: Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.
measure: Patient Oriented Composite Endpoint
time frame: 6 months
description: Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.
measure: Patient Oriented Composite Endpoint
time frame: 1 year
measure: Patient Oriented Composite Endpoint
time frame: 2 years
measure: Patient Oriented Composite Endpoint
time frame: 3 years
measure: Patient Oriented Composite Endpoint
time frame: 4 years
measure: Patient Oriented Composite Endpoint
time frame: 5 years
measure: Acute Success (Clinical Device and Clinical Procedure)
time frame: acute
description: Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable).
Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In dual lesion setting both lesions must meet clinical procedure success.
measure: Scaffold Thrombosis
time frame: 30days
description: Scaffold thrombosis will be categorized as acute (≤1day), subacute (>1day ≤30 days) and late (>30 days).
Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion).
In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the targetlesion within 30 days.
measure: Scaffold Thrombosis
time frame: 6 months
measure: Scaffold Thrombosis
time frame: 1 year
measure: Scaffold Thrombosis
time frame: 2 years
measure: Scaffold Thrombosis
time frame: 3 years
measure: Scaffold Thrombosis
time frame: 4 years
measure: Scaffold Thrombosis
time frame: 5 years
measure: Angiographic Endpoint
time frame: 6 months
description: In-segment In-scaffold, proximal and distal Late lumen loss (mm); In-segment In-scaffold, proximal and distal Minimal lumen diameter(mm); In-segment In-scaffold, proximal and distal Diameter stenosis (%) Angiographic Binary Restenosis (%).
measure: Angiographic Endpoint
time frame: 2 years
measure: Angiographic Endpoint
time frame: 5 years
measure: OCT Endpoint
time frame: 6 months
description: proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction.
measure: OCT Endpoint
time frame: 2 years
measure: OCT Endpoint
time frame: 5 years
measure: IVUS Endpoint
time frame: 6 months
description: mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area
measure: IVUS Endpoint
time frame: 2 years
measure: IVUS Endpoint
time frame: 5 years
measure: MSCT Endpoint
time frame: 1 year
description: mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area
measure: MSCT Endpoint
time frame: 3 years
arm group label: NeoVas BCS
arm group type: Experimental
description: The NeoVas sirolimus-eluting bioresorbable coronary scaffold system is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
intervention type: Device
intervention name: NeoVas BCS
description: The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and ischemia driven target lesion revascularization (TLF) at 1 month follow up. At 6 months, 1, 2, 3, 4 and 5 years follow-up, clinical endpoints include TLF (its individual components), Patient-oriented cardiac event (all cause death, all MI, and all revascularization) target vessel revascularization, scaffold thrombosis.
arm group label: NeoVas BCS
other name: NeoVas bioresorbable coronary scaffold
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yaling Han, MD
role: Study Chair
affiliation: The general hospital of Shenyang military region
last name: Guosheng Fu
role: Principal Investigator
affiliation: Sir Run Run Shaw Hospital
last name: Bo Xu
role: Principal Investigator
affiliation: Beijing Fuwai hospital, National center for cardiovascular diseases China
last name: Yao-Jun Zhang, PhD
role: Principal Investigator
affiliation: Nanjing First Hospital, Nanjing Medical University
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 