<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/NCT01681381</url>
  </required_header>
  <id_info>
    <org_study_id>I-LOVE-IT2</org_study_id>
    <nct_id>NCT01681381</nct_id>
  </id_info>
  <brief_title>Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization</brief_title>
  <official_title>A Prospective, Open Label, Randomized Study to Evaluate Safety And Effectiveness Of The Tivoli® Biodegradable Polymer Rapamycin-Eluting Stent and The FIREBIRD2® Rapamycin-Eluting Coronary CoCr Stent For Treatment Coronary Revascularization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Essen Technology (Beijing) Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Essen Technology (Beijing) Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-center, open label, randomized study to evaluate the efficacy&#xD;
      and safety of The TIVOLI Biodegradable polymer Rapamycin-Eluting Stent comparing with The&#xD;
      FIREBIRD2™ Rapamycin-eluting Stent (DES) for Treatment Coronary Revascularization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ischemia-driven Target Lesion Failure (TLF) which is a composite of cardiac death, myocardial infarction (Q and non-Q wave) and target lesion revascularization (TLR) at 12 months post-procedure.</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2790</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <condition>Myocardial Ischemia</condition>
  <condition>Coronary Artery Lesions,Primary</condition>
  <condition>Coronary Disease</condition>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Furcation Lesion of Coronary Artery</condition>
  <arm_group>
    <arm_group_label>Firebird2® DES</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device:Firebird2® DES The Firebird2® rapamycin-eluting stent (Firebird2® DES) is an open cell balloon expandable cobalt chromium stent coated with a biocompatible durable styrene-butylenes-styrene (SBS) polymer containing rapamycin at a dose of 9 micrograms per millimeter of stent length.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tivoli® DES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device:Tivoli® DES The Tivoli® DES is an open cell balloon expandable cobalt chromium stent coated with a bio-gradable polymer (PLGA) containing rapamycin at a dose of 8 micrograms per millimeter of stent length.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tivoli® DES</intervention_name>
    <description>Device:Tivoli® DES The Tivoli® DES drug eluting stent(Tivoli® DES) is an open cell balloon expandable cobalt chromium stent coated with a bio-gradable polymer (PLGA) containing rapamycin at a dose of 8 micrograms per millimeter of stent length. In vitro assays have shown that about 50% of the drug releasing in 1 week and approximately 80% releasing in 28 days. The polymer may be degraded in 3 to 6 months in human body. This stent is supplied pre-mounted on a delivery catheter and is available in the following sizes: lengths of 10、15、18、21、25、30、35 mm and diameters of 2.5、2.75、3.0、3.5、4.0 mm.</description>
    <arm_group_label>Firebird2® DES</arm_group_label>
    <arm_group_label>Tivoli® DES</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Firebird2® DES</intervention_name>
    <description>The Firebird2® rapamycin-eluting stent (Firebird2® DES) is an open cell balloon expandable cobalt chromium stent coated with a biocompatible durable styrene-butylenes-styrene (SBS) polymer containing rapamycin at a dose of 9 micrograms per millimeter of stent length. In vitro assays have shown that about 50% of the drug elutes in 1 week and approximately 90% elutes in 1 month. This stent is supplied pre-mounted on a delivery catheter and is available in the following sizes: lengths of 13, 18, 23, 29, 33 mm and diameters of 2.25, 2.5, 2.75, 3.0, 3.5, 4.0 mm.</description>
    <arm_group_label>Firebird2® DES</arm_group_label>
    <arm_group_label>Tivoli® DES</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • The patient must be ≥18 of age;&#xD;
&#xD;
               -  Symptomatic ischemic heart disease and/or objective evidence of myocardial&#xD;
                  ischemia including chronic stable coronary artery disease, or acute coronary&#xD;
                  syndrome including non-ST-elevation and ST-elevation myocardial infarction;&#xD;
&#xD;
               -  Acceptable candidate for CABG;&#xD;
&#xD;
               -  The patient is willing to comply with specified follow-up evaluations;4.Patients&#xD;
                  who agree to accept the follow-up visits.&#xD;
&#xD;
               -  Patients can understand the study objectives psychologically and linguistically&#xD;
                  and show the sufficient compliance to the study protocol. Patients present&#xD;
                  acceptance of the risks and benefits described in the informed consent form.&#xD;
&#xD;
        Angiographic Inclusion criteria:&#xD;
&#xD;
          -  At least one lesion with a diameter stenosis &gt;70% or more suitable for coronary stent&#xD;
             implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm;&#xD;
&#xD;
          -  Patients with multi-lesion or multi-vessel coronary disease, must have successful&#xD;
             treatment (&lt;30% diameter stenosis visual estimate) of the first treated lesion prior&#xD;
             to treatment of other lesions at the same brand of stent. Staged (planned) procedures&#xD;
             must be performed within 30 days of the index procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General Exclusion Criteria&#xD;
&#xD;
               -  Pregnant or nursing patients and those who plan pregnancy in the period up to 1&#xD;
                  year following index procedure.&#xD;
&#xD;
               -  Patient has a history of bleeding diathesis or coagulopathy or patients in whom&#xD;
                  anti-platelet and/or anticoagulant therapy is contraindicated or in which patient&#xD;
                  will not be able to comply with dual antiplatelet therapy for at least 1 year;&#xD;
&#xD;
               -  Patient has other medical illness (e.g., cancer, known malignancy, congestive&#xD;
                  heart failure, organ transplant recipient or candidate) or known history of&#xD;
                  substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance&#xD;
                  with the protocol, confound the data interpretation or is associated with a&#xD;
                  limited life expectancy (i.e., less than 1 year);&#xD;
&#xD;
               -  Left ventricular function &lt;40%;&#xD;
&#xD;
               -  Cardiogenic shock or hemodynamic compromise requiring pressors and/or inotropes&#xD;
                  or mechanical support;&#xD;
&#xD;
               -  Patient has a known hypersensitivity or contraindication to aspirin, heparin,&#xD;
                  clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, Rapamycinry ,&#xD;
                  styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast&#xD;
                  sensitivity that cannot be adequately pre-medicated;&#xD;
&#xD;
               -  Any significant medical condition which in the Investigator's opinion may&#xD;
                  interfere with the patient's optimal participation in the study;&#xD;
&#xD;
               -  Currently participating in another investigational drug or device study or&#xD;
                  patient in inclusion in another investigational drug or device study during&#xD;
                  follow-up.&#xD;
&#xD;
               -  Existing impairment in liver and kidney.&#xD;
&#xD;
               -  Extremely tortuous and/or calcification lesions.&#xD;
&#xD;
        Angiographic exclusion criteria:&#xD;
&#xD;
        • Two or more chronic total occlusions in the proximal half of the epicardial coronary&#xD;
        artery which cannot be recannalized.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Han Yaling, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The General Hospital of Shenyang Military Region</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The General Hospital of Shenyang Military Region</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>86-110016</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Han Yaling, Prof.</last_name>
      <phone>(86-024) 28851120</phone>
      <email>hanyaling@263.net</email>
    </contact>
    <investigator>
      <last_name>Han Yaling, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>February 20, 2013</last_update_submitted>
  <last_update_submitted_qc>February 20, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 21, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01681381
org study id: I-LOVE-IT2
nct id: NCT01681381
lead sponsor: 
has dmc: Yes
This is a prospective, multi-center, open label, randomized study to evaluate the efficacy
      and safety of The TIVOLI Biodegradable polymer Rapamycin-Eluting Stent comparing with The
      FIREBIRD2™ Rapamycin-eluting Stent (DES) for Treatment Coronary Revascularization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ischemia-driven Target Lesion Failure (TLF) which is a composite of cardiac death, myocardial infarction (Q and non-Q wave) and target lesion revascularization (TLR) at 12 months post-procedure.
time frame: 12 months
arm group label: Firebird2® DES
arm group type: Active Comparator
description: Device:Firebird2® DES The Firebird2® rapamycin-eluting stent (Firebird2® DES) is an open cell balloon expandable cobalt chromium stent coated with a biocompatible durable styrene-butylenes-styrene (SBS) polymer containing rapamycin at a dose of 9 micrograms per millimeter of stent length.
arm group label: Tivoli® DES
arm group type: Experimental
description: Device:Tivoli® DES The Tivoli® DES is an open cell balloon expandable cobalt chromium stent coated with a bio-gradable polymer (PLGA) containing rapamycin at a dose of 8 micrograms per millimeter of stent length.
intervention type: Device
intervention name: Tivoli® DES
description: Device:Tivoli® DES The Tivoli® DES drug eluting stent(Tivoli® DES) is an open cell balloon expandable cobalt chromium stent coated with a bio-gradable polymer (PLGA) containing rapamycin at a dose of 8 micrograms per millimeter of stent length. In vitro assays have shown that about 50% of the drug releasing in 1 week and approximately 80% releasing in 28 days. The polymer may be degraded in 3 to 6 months in human body. This stent is supplied pre-mounted on a delivery catheter and is available in the following sizes: lengths of 10、15、18、21、25、30、35 mm and diameters of 2.5、2.75、3.0、3.5、4.0 mm.
arm group label: Firebird2® DES
arm group label: Tivoli® DES
intervention type: Device
intervention name: Firebird2® DES
description: The Firebird2® rapamycin-eluting stent (Firebird2® DES) is an open cell balloon expandable cobalt chromium stent coated with a biocompatible durable styrene-butylenes-styrene (SBS) polymer containing rapamycin at a dose of 9 micrograms per millimeter of stent length. In vitro assays have shown that about 50% of the drug elutes in 1 week and approximately 90% elutes in 1 month. This stent is supplied pre-mounted on a delivery catheter and is available in the following sizes: lengths of 13, 18, 23, 29, 33 mm and diameters of 2.25, 2.5, 2.75, 3.0, 3.5, 4.0 mm.
arm group label: Firebird2® DES
arm group label: Tivoli® DES
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Han Yaling, Prof.
role: Principal Investigator
affiliation: The General Hospital of Shenyang Military Region
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Acute Coronary Syndrome
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Ischemia