<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/NCT01710748</url>
  </required_header>
  <id_info>
    <org_study_id>SEC-RES-2012-01</org_study_id>
    <nct_id>NCT01710748</nct_id>
  </id_info>
  <brief_title>Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients</brief_title>
  <acronym>RESERVOIR</acronym>
  <official_title>Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients (RESERVOIR) Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spanish Society of Cardiology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spanish Society of Cardiology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, randomized controlled, single blind, two-arm, multicenter&#xD;
      clinical evaluation.&#xD;
&#xD;
      Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of&#xD;
      the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2)&#xD;
      Polymer-Based Everolimus-Eluting Stent.&#xD;
&#xD;
      The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent&#xD;
      implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based&#xD;
      Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as&#xD;
      the primary imaging modality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients with diabetes mellitus (DM), drug eluting stents (DES) have been shown to be&#xD;
      associated with greater neointimal suppression than bare-metal stents. However, there is an&#xD;
      ongoing debate on the optimal drug-eluting stent in diabetic patients.&#xD;
&#xD;
      This study is a prospective, randomized controlled, single blind, two-arm, multicenter&#xD;
      clinical evaluation.&#xD;
&#xD;
      Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of&#xD;
      the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2)&#xD;
      Polymer-Based Everolimus-Eluting Stent.&#xD;
&#xD;
      The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent&#xD;
      implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based&#xD;
      Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as&#xD;
      the primary imaging modality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">July 2014</primary_completion_date>
  <phase>Phase 3</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neointimal hyperplasia volume obstruction</measure>
    <time_frame>9 months</time_frame>
    <description>The primary endpoint is assessed by Optical Coherence Tomography. It is defined as neointimal hyperplasia volume (mm3) divided by the stent volume multiplied by 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of uncovered struts</measure>
    <time_frame>9 months</time_frame>
    <description>This endpoint is assessed by Optical Coherence Tomography. Struts are classified as uncovered if any part of the strut is visibly exposed to the lumen, or covered if a layer of tissue is visible over all the reflecting surfaces.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of malapposed struts</measure>
    <time_frame>9 months</time_frame>
    <description>This endpoint is assessed by Optical Coherence Tomography. Apposition is assessed strut by strut by measuring the distance between the strut marker and the lumen contour. Struts with distance to lumen contour larger than the sum of strut + polymer thickness are considered malapposed. This results in incomplete strut apposition thresholds of 89 µm for the Xience Prime and 80 µm for the Cre8 stent. Struts located at the ostium of side branches, with no vessel wall behind, are excluded from the analysis of apposition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum percentage of NIH cross-sectional obstruction</measure>
    <time_frame>9 months</time_frame>
    <description>This endpoint is assessed by Optical Coherence Tomography. Percentage of NIH cross-sectional obstruction is defined as the NIH area (mm2) divided by the stent area multiplied by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death</measure>
    <time_frame>12 months</time_frame>
    <description>Death related to cardiac causes; if the cause of death cannot be determined, it will be also categorized as cardiac.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probable or definite stent thrombosis</measure>
    <time_frame>12 months</time_frame>
    <description>Stent thrombosis is considered according to the Academic Research Consortium definitions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel failure</measure>
    <time_frame>12 months</time_frame>
    <description>Target vessel failure is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated revascularization of the target vessel.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Polymer-Based Everolimus-Eluting Stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Polymer-Based Everolimus-Eluting Stent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Polymer-Free Amphilimus-Eluting Stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reservoir-Based Polymer-Free Amphilimus-Eluting Stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Polymer-Based Everolimus-Eluting Stent</intervention_name>
    <description>Polymer-Based Everolimus-Eluting Stent</description>
    <arm_group_label>Polymer-Based Everolimus-Eluting Stent</arm_group_label>
    <other_name>Xience Coronary Stent System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Polymer-Free Amphilimus-Eluting Stent</intervention_name>
    <description>Reservoir-Based Polymer-Free Amphilimus-Eluting Stent</description>
    <arm_group_label>Polymer-Free Amphilimus-Eluting Stent</arm_group_label>
    <other_name>Cre8 Coronary Stent System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Clinical Inclusion Criteria:&#xD;
&#xD;
          -  Subject is eligible for PCI.&#xD;
&#xD;
          -  Subject has symptomatic coronary artery disease (stable/unstable angina or Non-ST&#xD;
             elevation myocardial infarction).&#xD;
&#xD;
          -  Subject has known DM.&#xD;
&#xD;
        Angiographic Inclusion Criteria:&#xD;
&#xD;
          -  Presence of 1 or 2 de novo native coronary artery lesions (maximum 1 lesion per&#xD;
             epicardial coronary artery), with a visual estimation stenosis ≥ 50%.&#xD;
&#xD;
          -  Target lesion length 12-25mm, reference diameter 2.5-3.5mm.&#xD;
&#xD;
        Clinical Exclusion Criteria:&#xD;
&#xD;
          -  ST-segment elevation myocardial infarction &lt;48h&#xD;
&#xD;
          -  Presence of cardiogenic shock pre-procedure&#xD;
&#xD;
          -  Contra-indications to dual antiplatelet therapy for 12 months&#xD;
&#xD;
          -  Left Ventricular Ejection Fraction ≤30%&#xD;
&#xD;
          -  GFR&lt;30 ml/min/m2&#xD;
&#xD;
          -  Target vessel has been treated previously&#xD;
&#xD;
          -  Platelet count &lt;75000/mm3 or &gt;700000/mm3&#xD;
&#xD;
          -  Immunosuppressive therapy&#xD;
&#xD;
          -  Has received or waiting list for any transplant&#xD;
&#xD;
          -  Life-threatening disease with a life expectancy of &lt; 12 months&#xD;
&#xD;
          -  Pregnant or breast feeding patient&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
        Angiographic Exclusion Criteria:&#xD;
&#xD;
          -  TIMI flow ≤ 1 prior to guide wire crossing&#xD;
&#xD;
          -  There is an additional lesion within the target vessel planned to be treated within&#xD;
             the next 12 months&#xD;
&#xD;
          -  Target vessel is a saphenous vein graft&#xD;
&#xD;
          -  Target vessel is the left main, ostial LAD and/or ostial LCX.&#xD;
&#xD;
          -  Prior PCI of the target lesion (restenosis)&#xD;
&#xD;
          -  Lesion cannot be covered by a single stent (unplanned bailout stenting is allowed)&#xD;
&#xD;
          -  Involved side branch ≥2.5mm by visual estimation&#xD;
&#xD;
          -  Rotablator, ELCA or brachytherapy&#xD;
&#xD;
          -  Severe calcification of 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>Rafael Romaguera, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spanish Society of Cardiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Clínic i Provincial</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Arrixaca</name>
      <address>
        <city>Murcia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>November 5, 2013</last_update_submitted>
  <last_update_submitted_qc>November 5, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spanish Society of Cardiology</investigator_affiliation>
    <investigator_full_name>Dr Rafael Romaguera</investigator_full_name>
    <investigator_title>Dr. Rafael Romaguera</investigator_title>
  </responsible_party>
  <keyword>Percutaneous coronary intervention</keyword>
  <keyword>Drug eluting stent</keyword>
  <keyword>Neointimal hyperplasia</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Everolimus</mesh_term>
  </intervention_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/NCT01710748
org study id: SEC-RES-2012-01
nct id: NCT01710748
lead sponsor: 
has dmc: No
This study is a prospective, randomized controlled, single blind, two-arm, multicenter
      clinical evaluation.

      Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of
      the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2)
      Polymer-Based Everolimus-Eluting Stent.

      The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent
      implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based
      Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as
      the primary imaging modality.
In patients with diabetes mellitus (DM), drug eluting stents (DES) have been shown to be
      associated with greater neointimal suppression than bare-metal stents. However, there is an
      ongoing debate on the optimal drug-eluting stent in diabetic patients.

      This study is a prospective, randomized controlled, single blind, two-arm, multicenter
      clinical evaluation.

      Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of
      the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2)
      Polymer-Based Everolimus-Eluting Stent.

      The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent
      implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based
      Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as
      the primary imaging modality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Neointimal hyperplasia volume obstruction
time frame: 9 months
description: The primary endpoint is assessed by Optical Coherence Tomography. It is defined as neointimal hyperplasia volume (mm3) divided by the stent volume multiplied by 100.
measure: Percentage of uncovered struts
time frame: 9 months
description: This endpoint is assessed by Optical Coherence Tomography. Struts are classified as uncovered if any part of the strut is visibly exposed to the lumen, or covered if a layer of tissue is visible over all the reflecting surfaces.
measure: Percentage of malapposed struts
time frame: 9 months
description: This endpoint is assessed by Optical Coherence Tomography. Apposition is assessed strut by strut by measuring the distance between the strut marker and the lumen contour. Struts with distance to lumen contour larger than the sum of strut + polymer thickness are considered malapposed. This results in incomplete strut apposition thresholds of 89 µm for the Xience Prime and 80 µm for the Cre8 stent. Struts located at the ostium of side branches, with no vessel wall behind, are excluded from the analysis of apposition.
measure: Maximum percentage of NIH cross-sectional obstruction
time frame: 9 months
description: This endpoint is assessed by Optical Coherence Tomography. Percentage of NIH cross-sectional obstruction is defined as the NIH area (mm2) divided by the stent area multiplied by 100.
measure: Cardiac death
time frame: 12 months
description: Death related to cardiac causes; if the cause of death cannot be determined, it will be also categorized as cardiac.
measure: Probable or definite stent thrombosis
time frame: 12 months
description: Stent thrombosis is considered according to the Academic Research Consortium definitions
measure: Target vessel failure
time frame: 12 months
description: Target vessel failure is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated revascularization of the target vessel.
arm group label: Polymer-Based Everolimus-Eluting Stent
arm group type: Active Comparator
description: Polymer-Based Everolimus-Eluting Stent
arm group label: Polymer-Free Amphilimus-Eluting Stent
arm group type: Experimental
description: Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
intervention type: Device
intervention name: Polymer-Based Everolimus-Eluting Stent
description: Polymer-Based Everolimus-Eluting Stent
arm group label: Polymer-Based Everolimus-Eluting Stent
other name: Xience Coronary Stent System
intervention type: Device
intervention name: Polymer-Free Amphilimus-Eluting Stent
description: Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
arm group label: Polymer-Free Amphilimus-Eluting Stent
other name: Cre8 Coronary Stent System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rafael Romaguera, MD
role: Principal Investigator
affiliation: Spanish Society of Cardiology
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Spanish Society of Cardiology
investigator full name: Dr Rafael Romaguera
investigator title: Dr. Rafael Romaguera
mesh term: Coronary Artery Disease
mesh term: Diabetes Mellitus
mesh term: Everolimus