<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/NCT03236415</url>
  </required_header>
  <id_info>
    <org_study_id>20170128-01H</org_study_id>
    <nct_id>NCT03236415</nct_id>
  </id_info>
  <brief_title>Comparative Response to Vascular Injury in Patients With Diabetes Mellitus: An OCT Study of BVS Versus Xience DES</brief_title>
  <official_title>Comparative Response to Vascular Injury in Patients With Diabetes Mellitus: An OCT Study of BVS Versus Xience DES</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Heart Institute Research Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Heart Institute Research Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stents are used at centers around the world to unblock the arteries of the heart. These&#xD;
      stents are usually made of metal and remain permanently within the blood vessel wall. Newer&#xD;
      developments in the stent technology has led to stent scaffolds that can be reabsorbed over&#xD;
      time. Patients with diabetes are prone to more complex blockages in the heart arteries which&#xD;
      can be more difficult to treat. The purpose of this study is to compare the difference of how&#xD;
      arteries heal early when metal stents or resorbable stents are used in patients with&#xD;
      diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary revascularization by percutaneous coronary intervention (PCI) is the dominant&#xD;
      strategy in patients with obstructive coronary artery disease (CAD). Traditionally, PCI is&#xD;
      performed with implantation of one or more permanent metallic stents which act as a scaffold&#xD;
      for arterial recoil and, in the case of drug eluting stents (DES), provide a platform for&#xD;
      delivery of anti-proliferative agents. A recent innovation in coronary stent technology is&#xD;
      the advent of a bioresorbable vascular scaffold (BVS) - a poly L-lactide (PLLA) scaffold&#xD;
      covered with a poly D,L-lactide coating which elutes everolimus. Bioresorption occurs by&#xD;
      de-esterification of the long chains of PLLA into small particles which are then phagocytosed&#xD;
      by macrophages. Within two years, the BVS is completely resorbed and vasomotor reactivity of&#xD;
      the blood vessel is restored.&#xD;
&#xD;
      Patients with diabetes mellitus (DM) represent a clinically challenging population - having&#xD;
      an increased incidence of complex CAD as well as higher rates of stent thrombosis (ST) and&#xD;
      in-stent restenosis (ISR) following PCI. ST occurs most frequently in the first thirty days&#xD;
      following stent implantation and is prevented by effective antiplatelet medications,&#xD;
      optimization of stent deployment and by rapid reendothelialization (RE) of the device.&#xD;
      Notably, patients with DM have delayed RE following stent implantation which results in a&#xD;
      marked increase in risk of ST. Thus, patients with DM in particular are in need of devices&#xD;
      that result in rapid establishment of stent coverage by optimizing the response to vascular&#xD;
      injury.&#xD;
&#xD;
      Our study aims to answer the question: &quot;Are there important differences in early healing&#xD;
      between BVS and DES in patients with DM?&quot; Our study hypothesis is that a BVS platform will&#xD;
      enhance vascular healing resulting in greater strut coverage by 6 weeks in patients with DM.&#xD;
&#xD;
      This is a single centre, interventional, prospective cohort study which will be conducted&#xD;
      between July 2017 and July 2019. A total of 52 patients will be recruited for participation&#xD;
      in this study. Stable patients with diabetes will undergo randomization to either BVS or DES&#xD;
      in the first target lesion using optical coherence tomography (OCT) at the time of the index&#xD;
      procedure. Subsequently, patients will undergo staged PCI at four or six weeks&#xD;
      (sub-randomization) of the second lesion with OCT evaluation of the initially implanted&#xD;
      device to determine the percent of uncovered struts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Global sales of the Absorb BVS halted effective September 14, 2017.&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</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>Percentage of uncovered struts at time of follow-up optical coherence tomography</measure>
    <time_frame>4 to 6 weeks</time_frame>
    <description>The primary outcome will be the percent of uncovered struts analyzed at 5mm segments using a standardized protocol for optical coherence tomography at time of staged percutaneous coronary intervention procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Late lumen loss</measure>
    <time_frame>4 to 6 weeks</time_frame>
    <description>Assessment of standardized lumen area at 5mm increments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neointimal area:artery area</measure>
    <time_frame>4 to 6 weeks</time_frame>
    <description>Assessment of standardized neointimal area:artery area at 5mm increments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strut malapposition</measure>
    <time_frame>4 to 6 weeks</time_frame>
    <description>Assessment of strut malapposition as a percentage of total struts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-stent restenosis</measure>
    <time_frame>4 to 6 weeks</time_frame>
    <description>Binary in-stent restenosis defined as greater than 50% in-stent lumen loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion revascularization</measure>
    <time_frame>4 to 6 weeks</time_frame>
    <description>Any intervention within 5mm of the study device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac events</measure>
    <time_frame>4 to 6 weeks</time_frame>
    <description>A composite of death, myocardial infarction or stroke</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Subgroup analysis between 4 and 6 weeks</measure>
    <time_frame>4 to 6 weeks</time_frame>
    <description>A subgroup analysis between four and six weeks will be performed to study the gradation of intimal response during early vascular healing</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Xience Drug Eluting Stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with diabetes mellitus will be randomized to receive either a Xience drug eluting stent or an ABSORB bioresorbable vascular scaffold for treatment of obstructive coronary artery disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABSORB Bioresorbable Vascular Scaffold</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with diabetes mellitus will be randomized to receive either a Xience drug eluting stent or an ABSORB bioresorbable vascular scaffold for treatment of obstructive coronary artery diseasee</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Xience Drug Eluting Stent</intervention_name>
    <description>Patients will undergo insertion of a drug eluting stent with assessment of strut coverage using optical coherence tomography at 4 to 6 weeks after implantation.</description>
    <arm_group_label>Xience Drug Eluting Stent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ABSORB Bioresorbable Vascular Scaffold</intervention_name>
    <description>Patients will undergo insertion of a bioresorbable vascular scaffold with assessment of strut coverage using optical coherence tomography at 4 to 6 weeks after implantation.</description>
    <arm_group_label>ABSORB Bioresorbable Vascular Scaffold</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Stable patients with diabetes mellitus&#xD;
&#xD;
          2. Two or more stenoses in a major epicardial native coronary artery&#xD;
&#xD;
          3. An indication for PCI (i.e. &gt;70% on angiography or fractional flow reserve (FFR) &lt;0.8)&#xD;
&#xD;
          4. Coronary anatomy suitable for a BVS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwillingness or inability to provide informed consent.&#xD;
&#xD;
          2. ST-elevation myocardial infarction&#xD;
&#xD;
          3. Hemodynamic instability&#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>Benjamin Hibbert, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Heart Institute Research Corporation</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>October 18, 2017</last_update_submitted>
  <last_update_submitted_qc>October 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2017</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>Coronary Artery Disease</mesh_term>
    <mesh_term>Vascular System Injuries</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03236415
org study id: 20170128-01H
nct id: NCT03236415
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Stents are used at centers around the world to unblock the arteries of the heart. These
      stents are usually made of metal and remain permanently within the blood vessel wall. Newer
      developments in the stent technology has led to stent scaffolds that can be reabsorbed over
      time. Patients with diabetes are prone to more complex blockages in the heart arteries which
      can be more difficult to treat. The purpose of this study is to compare the difference of how
      arteries heal early when metal stents or resorbable stents are used in patients with
      diabetes.
Coronary revascularization by percutaneous coronary intervention (PCI) is the dominant
      strategy in patients with obstructive coronary artery disease (CAD). Traditionally, PCI is
      performed with implantation of one or more permanent metallic stents which act as a scaffold
      for arterial recoil and, in the case of drug eluting stents (DES), provide a platform for
      delivery of anti-proliferative agents. A recent innovation in coronary stent technology is
      the advent of a bioresorbable vascular scaffold (BVS) - a poly L-lactide (PLLA) scaffold
      covered with a poly D,L-lactide coating which elutes everolimus. Bioresorption occurs by
      de-esterification of the long chains of PLLA into small particles which are then phagocytosed
      by macrophages. Within two years, the BVS is completely resorbed and vasomotor reactivity of
      the blood vessel is restored.

      Patients with diabetes mellitus (DM) represent a clinically challenging population - having
      an increased incidence of complex CAD as well as higher rates of stent thrombosis (ST) and
      in-stent restenosis (ISR) following PCI. ST occurs most frequently in the first thirty days
      following stent implantation and is prevented by effective antiplatelet medications,
      optimization of stent deployment and by rapid reendothelialization (RE) of the device.
      Notably, patients with DM have delayed RE following stent implantation which results in a
      marked increase in risk of ST. Thus, patients with DM in particular are in need of devices
      that result in rapid establishment of stent coverage by optimizing the response to vascular
      injury.

      Our study aims to answer the question: "Are there important differences in early healing
      between BVS and DES in patients with DM?" Our study hypothesis is that a BVS platform will
      enhance vascular healing resulting in greater strut coverage by 6 weeks in patients with DM.

      This is a single centre, interventional, prospective cohort study which will be conducted
      between July 2017 and July 2019. A total of 52 patients will be recruited for participation
      in this study. Stable patients with diabetes will undergo randomization to either BVS or DES
      in the first target lesion using optical coherence tomography (OCT) at the time of the index
      procedure. Subsequently, patients will undergo staged PCI at four or six weeks
      (sub-randomization) of the second lesion with OCT evaluation of the initially implanted
      device to determine the percent of uncovered struts.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of uncovered struts at time of follow-up optical coherence tomography
time frame: 4 to 6 weeks
description: The primary outcome will be the percent of uncovered struts analyzed at 5mm segments using a standardized protocol for optical coherence tomography at time of staged percutaneous coronary intervention procedure
measure: Late lumen loss
time frame: 4 to 6 weeks
description: Assessment of standardized lumen area at 5mm increments
measure: Neointimal area:artery area
time frame: 4 to 6 weeks
description: Assessment of standardized neointimal area:artery area at 5mm increments
measure: Strut malapposition
time frame: 4 to 6 weeks
description: Assessment of strut malapposition as a percentage of total struts
measure: In-stent restenosis
time frame: 4 to 6 weeks
description: Binary in-stent restenosis defined as greater than 50% in-stent lumen loss
measure: Target lesion revascularization
time frame: 4 to 6 weeks
description: Any intervention within 5mm of the study device
measure: Major adverse cardiac events
time frame: 4 to 6 weeks
description: A composite of death, myocardial infarction or stroke
measure: Subgroup analysis between 4 and 6 weeks
time frame: 4 to 6 weeks
description: A subgroup analysis between four and six weeks will be performed to study the gradation of intimal response during early vascular healing
arm group label: Xience Drug Eluting Stent
arm group type: Active Comparator
description: Patients with diabetes mellitus will be randomized to receive either a Xience drug eluting stent or an ABSORB bioresorbable vascular scaffold for treatment of obstructive coronary artery disease
arm group label: ABSORB Bioresorbable Vascular Scaffold
arm group type: Active Comparator
description: Patients with diabetes mellitus will be randomized to receive either a Xience drug eluting stent or an ABSORB bioresorbable vascular scaffold for treatment of obstructive coronary artery diseasee
intervention type: Device
intervention name: Xience Drug Eluting Stent
description: Patients will undergo insertion of a drug eluting stent with assessment of strut coverage using optical coherence tomography at 4 to 6 weeks after implantation.
arm group label: Xience Drug Eluting Stent
intervention type: Device
intervention name: ABSORB Bioresorbable Vascular Scaffold
description: Patients will undergo insertion of a bioresorbable vascular scaffold with assessment of strut coverage using optical coherence tomography at 4 to 6 weeks after implantation.
arm group label: ABSORB Bioresorbable Vascular Scaffold
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Hibbert, MD PhD
role: Principal Investigator
affiliation: Ottawa Heart Institute Research Corporation
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Vascular System Injuries
mesh term: Diabetes Mellitus
sharing ipd: No