<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/NCT01718106</url>
  </required_header>
  <id_info>
    <org_study_id>846/CE</org_study_id>
    <nct_id>NCT01718106</nct_id>
  </id_info>
  <brief_title>Single Long vs Two Short Overlapping Bioabsorbable Polymer DES</brief_title>
  <acronym>ROCCO</acronym>
  <official_title>Randomized Study to Evaluate Segmental Late Loss Comparing Two PCI Strategies Using a Long Stent vs 2 Shorter Stents to Treat Long or Tandem Coronary Stenosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliero Universitaria Maggiore della Carita</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliero Universitaria Maggiore della Carita</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multiple overlapping drug-eluting coronary stents (DES) are usually needed to treat long&#xD;
      coronary stenoses but this strategy is expensive and the response to overlapping DES has not&#xD;
      been extensively studied. The recent availability of bioabsorbable polymer DES could allow&#xD;
      treatment of long coronary stenoses without leaving gross burden of non-absorbable polymer in&#xD;
      the vessel wall, even in case of overlapping stents.&#xD;
&#xD;
      Thus we planned to evaluate which of the 2 strategies, namely using a single long&#xD;
      biabsorbable DES or two shorter biabsorbable DES with minimal overlapping, is better in&#xD;
      treating long coronary stenoses.&#xD;
&#xD;
      The study is a spontanous randomized multicenter open-label study. A maximum of 300 patients&#xD;
      with stable angina and at leat 1 coronary stenosis &gt;28mm and &lt;40mm of length will be&#xD;
      randomized in 1:1 fashion by a Web-based electronic CRF. The long stent group (Group A) will&#xD;
      be treated by a single 44mm Biomime DES (II generation DES with bioabsorbable polymer, Meril&#xD;
      Life Sciences Pvt. Ltd., Gujarat, India). The short stent group (Group B) will be treated by&#xD;
      2 short Biomime DES positioned with minimal overlapping. The primary end-point of the study&#xD;
      will be the 6 moth in-stent late lumen loss. Seconadry end-points will be 1, 6 and 12 month&#xD;
      overall mortality, myocardial infarction, target vessel revascularization, stent thrombosis&#xD;
      and MACE (combination of the 3 previous clinical end-points). Patients will be evaluated by&#xD;
      6-month control coronary angiography and late lumen loss in the stented vessel will be&#xD;
      measured in a quantitative coronary angiography Core Lab (Cardioimaging Centre, Novara,&#xD;
      Italy)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>follow up in-stent late lumen loss</measure>
    <time_frame>6-month</time_frame>
    <description>difference between the in-stent coronary lumen measure obtained immediately after coronary percutaneous intervention and the in-stent coronary lumen measure at follow up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall mortality</measure>
    <time_frame>1 year</time_frame>
    <description>mortality for all causes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>1 year</time_frame>
    <description>Myocardial infarction (universal definition of myocardial infarction, ACC/AHA/ESC statement) in the territory of the treated coronary artery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>target vessel revascularization</measure>
    <time_frame>1 year</time_frame>
    <description>revascularization of the treated coronary vessel by repeated percutaneous coronary intervention or coronary artery bypass grafting due to restenosis and or symptoms or instrumental signs of myocardial ischemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>2 years</time_frame>
    <description>Coronary stent thrombosis according to ARC definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACE (major coronary adverse event)</measure>
    <time_frame>1 year</time_frame>
    <description>combined endpoint = presence of overall death or myocardial infarction or target vessel revascularization or stent thrombosis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Single long bioabsorbable polymer DES</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with long coronary stenosis treated by a single long bioabsorbable polymer DES</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Two bioabsorbable polymer DES in overlapping</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients with long coronary artery stenosis tretaed by 2 bioabsorbable polymer DES with minimal overlapping</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>implantation of a bioabsorbable polymer DES</intervention_name>
    <description>implantation in patients with long coronary artery stenosis of a single long or two shorter overlapped bioabsorbable polymer DES</description>
    <arm_group_label>Single long bioabsorbable polymer DES</arm_group_label>
    <arm_group_label>Two bioabsorbable polymer DES in overlapping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. De novo coronary artery stenosis in a major coronary artery branch (reference diameter&#xD;
             2.5-4.0 mm) with a lenght &gt;28mm and &lt;39mm&#xD;
&#xD;
          2. Symptoms or instrumental evidence of myocardial ischemia:&#xD;
&#xD;
               -  Chronic stable angina [Canadian Cardiovascular Society Classification]&#xD;
&#xD;
               -  Unstable angina with ECG changes or troponin release (Braunwald Class IB-C,&#xD;
                  IIB-C, or IIIB-C)&#xD;
&#xD;
               -  Stress ECG or myocardial perfusion imaging or stress echocardiography positive&#xD;
                  for inducible myocardial ischemia&#xD;
&#xD;
          3. Written informed consent to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or lactation&#xD;
&#xD;
          2. Acute ST elevation myocardial infarction (primary angioplasty)&#xD;
&#xD;
          3. Cardiogenic shock&#xD;
&#xD;
          4. Known allergic reactions to aspirin, clopidogrel, prasugrel, heparin, enoxaparin,&#xD;
             bivalirudin, steel, chromium, iodiate contrast medium&#xD;
&#xD;
          5. Platelets &lt;75.000/mm3 or &gt;700.000/mm3 or white blood cells &lt;3.000/mm3.&#xD;
&#xD;
          6. Partecipation to other studies.&#xD;
&#xD;
          7. Active or &lt;3 months peptic ulcer or gastrointestinal bleeding&#xD;
&#xD;
          8. Planned major surgery non delayable .&#xD;
&#xD;
          9. Comorbidities limiting life expectancy to &lt;1 year.&#xD;
&#xD;
         10. Unprotected left main disease as target lesion&#xD;
&#xD;
         11. Chronic total occlusion as target lesion&#xD;
&#xD;
         12. Bifurcation with side branch &gt; 2.5mm as target lesion&#xD;
&#xD;
         13. Restenosis as target lesion&#xD;
&#xD;
         14. saphenous vein graft as target lesion.&#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>Alessandro Lupi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AOU Maggiore della Carità - Novara</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Angelo S Bongo, MD</last_name>
    <role>Study Chair</role>
    <affiliation>AOU Maggiore della Carità - Novara</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alessandro Lupi, MD</last_name>
    <phone>+3903213733236</phone>
    <email>lupialessandro1@tin.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ospedale Maggiore della Carità</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alessandro Lupi, MD</last_name>
      <phone>+3903213733236</phone>
      <email>lupialessandro1@tin.it</email>
    </contact>
    <investigator>
      <last_name>Alessandro Lupi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrea Rognoni, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://rocco.zeusdatapower.com</url>
    <description>electronic CRF URL</description>
  </link>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>March 25, 2015</last_update_submitted>
  <last_update_submitted_qc>March 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliero Universitaria Maggiore della Carita</investigator_affiliation>
    <investigator_full_name>Lupi Alessandro</investigator_full_name>
    <investigator_title>Dr Alessandro Lupi, Cardiologia Ospedaliera, AOU Maggiore della Carità, Novara.</investigator_title>
  </responsible_party>
  <keyword>coronary artery disease</keyword>
  <keyword>drug eluting stent</keyword>
  <keyword>bioabsorbable polymer</keyword>
  <keyword>percutaneous coronary intervention</keyword>
  <keyword>restenosis</keyword>
  <keyword>late thrombosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01718106
org study id: 846/CE
nct id: NCT01718106
lead sponsor: 
has dmc: Yes
Multiple overlapping drug-eluting coronary stents (DES) are usually needed to treat long
      coronary stenoses but this strategy is expensive and the response to overlapping DES has not
      been extensively studied. The recent availability of bioabsorbable polymer DES could allow
      treatment of long coronary stenoses without leaving gross burden of non-absorbable polymer in
      the vessel wall, even in case of overlapping stents.

      Thus we planned to evaluate which of the 2 strategies, namely using a single long
      biabsorbable DES or two shorter biabsorbable DES with minimal overlapping, is better in
      treating long coronary stenoses.

      The study is a spontanous randomized multicenter open-label study. A maximum of 300 patients
      with stable angina and at leat 1 coronary stenosis >28mm and <40mm of length will be
      randomized in 1:1 fashion by a Web-based electronic CRF. The long stent group (Group A) will
      be treated by a single 44mm Biomime DES (II generation DES with bioabsorbable polymer, Meril
      Life Sciences Pvt. Ltd., Gujarat, India). The short stent group (Group B) will be treated by
      2 short Biomime DES positioned with minimal overlapping. The primary end-point of the study
      will be the 6 moth in-stent late lumen loss. Seconadry end-points will be 1, 6 and 12 month
      overall mortality, myocardial infarction, target vessel revascularization, stent thrombosis
      and MACE (combination of the 3 previous clinical end-points). Patients will be evaluated by
      6-month control coronary angiography and late lumen loss in the stented vessel will be
      measured in a quantitative coronary angiography Core Lab (Cardioimaging Centre, Novara,
      Italy)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: follow up in-stent late lumen loss
time frame: 6-month
description: difference between the in-stent coronary lumen measure obtained immediately after coronary percutaneous intervention and the in-stent coronary lumen measure at follow up
measure: overall mortality
time frame: 1 year
description: mortality for all causes
measure: Myocardial infarction
time frame: 1 year
description: Myocardial infarction (universal definition of myocardial infarction, ACC/AHA/ESC statement) in the territory of the treated coronary artery
measure: target vessel revascularization
time frame: 1 year
description: revascularization of the treated coronary vessel by repeated percutaneous coronary intervention or coronary artery bypass grafting due to restenosis and or symptoms or instrumental signs of myocardial ischemia
measure: Stent thrombosis
time frame: 2 years
description: Coronary stent thrombosis according to ARC definition
measure: MACE (major coronary adverse event)
time frame: 1 year
description: combined endpoint = presence of overall death or myocardial infarction or target vessel revascularization or stent thrombosis
arm group label: Single long bioabsorbable polymer DES
arm group type: Active Comparator
description: Patients with long coronary stenosis treated by a single long bioabsorbable polymer DES
arm group label: Two bioabsorbable polymer DES in overlapping
arm group type: Active Comparator
description: patients with long coronary artery stenosis tretaed by 2 bioabsorbable polymer DES with minimal overlapping
intervention type: Device
intervention name: implantation of a bioabsorbable polymer DES
description: implantation in patients with long coronary artery stenosis of a single long or two shorter overlapped bioabsorbable polymer DES
arm group label: Single long bioabsorbable polymer DES
arm group label: Two bioabsorbable polymer DES in overlapping
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alessandro Lupi, MD
role: Principal Investigator
affiliation: AOU Maggiore della Carità - Novara
last name: Angelo S Bongo, MD
role: Study Chair
affiliation: AOU Maggiore della Carità - Novara
last name: Alessandro Lupi, MD
phone: +3903213733236
email: lupialessandro1@tin.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Italy
url: http://rocco.zeusdatapower.com
description: electronic CRF URL
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliero Universitaria Maggiore della Carita
investigator full name: Lupi Alessandro
investigator title: Dr Alessandro Lupi, Cardiologia Ospedaliera, AOU Maggiore della Carità, Novara.
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease