<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/NCT02237066</url>
  </required_header>
  <id_info>
    <org_study_id>Chocolate OCT</org_study_id>
    <nct_id>NCT02237066</nct_id>
  </id_info>
  <brief_title>Understanding Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging</brief_title>
  <official_title>Understanding the Mechanism of Peripheral Arterial Balloon Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TriReme Medical, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>TriReme Medical, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the Chocolate PTA Balloon to standard Percutaneous&#xD;
      Transluminal Angioplasty (PTA) catheters. The investigators will use Optical Coherence&#xD;
      Tomography (OCT) and Quantitative Vascular Angiography to evaluate the acute vascular&#xD;
      response of vessels treated with the Chocolate Balloon to a standard balloon catheter, with&#xD;
      the primary endpoint being luminal gain assessed by OCT lumen volume measurements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be randomized to treatment with either the Chocolate Balloon catheter or a&#xD;
      standard balloon angioplasty catheter. All angioplasty procedures will be conducted with&#xD;
      treatment balloon at the full discretion of the physician and according to the standard&#xD;
      practice at the hospital and the device Instructions for Use. All patients will undergo&#xD;
      baseline OCT imaging in addition to standard angiography. Post-PTA, all patients will then&#xD;
      undergo repeat OCT imaging immediately post-procedure and then again at 10-minutes&#xD;
      post-procedure to assess for vascular recoil.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Enrollment goals were not able to be met&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">March 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>Luminal Gain</measure>
    <time_frame>Average of 90 minutes</time_frame>
    <description>Luminal Gain as defined by OCT lumen volume measurements. Luminal gain is assessed as the percentage change comparing pre-treatment and post-treatment volume measurements in cubic centimeters (CC) or millimeters (m3).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dissection</measure>
    <time_frame>Average of 90 minutes</time_frame>
    <description>Dissection severity (extension) as defined by both angiographic and OCT metrics.&#xD;
Dissections occur when the blood goes into the vessel wall instead of staying in the vessel lumen. Dissection severity is determined by a visual review of the angiogram and OCT images by an independent core lab. Dissections are classified as flow-limiting (more severe) vs. non-flow limiting (less severe) based upon the amount of the blood that is flowing into the vessel wall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematoma</measure>
    <time_frame>Average of 90 minutes</time_frame>
    <description>Presence of intramural hematoma on OCT.&#xD;
A hematoma can be visually observed on a angiogram and an OCT image. The images will be independently reviewed by a core lab expert who will document if a hematoma is present or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimal PTA</measure>
    <time_frame>Average of 90 minutes</time_frame>
    <description>Achievement of Optimal PTA (&lt;30% Diameter stenosis without flow limiting dissection)&#xD;
&lt;30% Diameter stenosis and flow limiting dissections are visual assessments that will be conducted by an independent core lab review. The % diameter stenosis measures the amount of plaque that is in the vessel and a flow-limiting dissection is observed as either present or not present.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Infrainguinal Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Chocolate PTA Balloon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chocolate PTA Balloon Angioplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard PTA Balloon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard PTA Balloon Angioplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Chocolate PTA Balloon Angioplasty</intervention_name>
    <description>OCT imaging of diseased vessel is treated with an Angioplasty Procedure using the Chocolate PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later</description>
    <arm_group_label>Chocolate PTA Balloon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard PTA Balloon Angioplasty</intervention_name>
    <description>OCT imaging of diseased vessel is treated with an Angioplasty Procedure using a standard PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later</description>
    <arm_group_label>Standard PTA Balloon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Reference Vessel Diameter (RVD) between 2.5 and 6.0mm and within treatment range of&#xD;
             available balloon at Target Lesion&#xD;
&#xD;
          -  Intermittent claudication or critical limb ischemia (Rutherford 3-5)&#xD;
&#xD;
          -  De novo stenosis (≥70%) or occlusion in the infrainguinal arteries, including&#xD;
             superficial femoral artery (SFA), popliteal, and infrapopliteal arteries.&#xD;
&#xD;
          -  Lesion successfully crossed with a guide-wire&#xD;
&#xD;
          -  Patient has given informed consent to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lesion requiring ablative procedures (i.e. atherectomy or laser) as part of treatment&#xD;
&#xD;
          -  Lesion length &gt;75mm&#xD;
&#xD;
          -  Previous bypass or stent at target vessel or proximal to target vessel&#xD;
&#xD;
          -  Significant in-flow disease at target lesion&#xD;
&#xD;
          -  Known inadequate distal outflow disease or planned treatment of vessel distal to&#xD;
             target lesion&#xD;
&#xD;
          -  Acute limb ischemia or need for thrombolytic therapy&#xD;
&#xD;
          -  Known intolerance to required study medications, contrast media, or nitinol&#xD;
&#xD;
          -  Known impaired Renal Function with Glomerular Filtration Rate (GFR) &lt;45 ml/min per&#xD;
             1.73m2&#xD;
&#xD;
          -  Known bleeding disorder or uncontrolled hypercoagulable disorder.&#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>Sahil A Parikh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harrington Heart and Vascular Institute University Hospitals Case Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>March 17, 2015</last_update_submitted>
  <last_update_submitted_qc>March 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OCT</keyword>
  <keyword>PTA</keyword>
  <keyword>Balloon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</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/NCT02237066
org study id: Chocolate OCT
nct id: NCT02237066
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to compare the Chocolate PTA Balloon to standard Percutaneous
      Transluminal Angioplasty (PTA) catheters. The investigators will use Optical Coherence
      Tomography (OCT) and Quantitative Vascular Angiography to evaluate the acute vascular
      response of vessels treated with the Chocolate Balloon to a standard balloon catheter, with
      the primary endpoint being luminal gain assessed by OCT lumen volume measurements.
Subjects will be randomized to treatment with either the Chocolate Balloon catheter or a
      standard balloon angioplasty catheter. All angioplasty procedures will be conducted with
      treatment balloon at the full discretion of the physician and according to the standard
      practice at the hospital and the device Instructions for Use. All patients will undergo
      baseline OCT imaging in addition to standard angiography. Post-PTA, all patients will then
      undergo repeat OCT imaging immediately post-procedure and then again at 10-minutes
      post-procedure to assess for vascular recoil.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Luminal Gain
time frame: Average of 90 minutes
description: Luminal Gain as defined by OCT lumen volume measurements. Luminal gain is assessed as the percentage change comparing pre-treatment and post-treatment volume measurements in cubic centimeters (CC) or millimeters (m3).
measure: Dissection
time frame: Average of 90 minutes
description: Dissection severity (extension) as defined by both angiographic and OCT metrics.
Dissections occur when the blood goes into the vessel wall instead of staying in the vessel lumen. Dissection severity is determined by a visual review of the angiogram and OCT images by an independent core lab. Dissections are classified as flow-limiting (more severe) vs. non-flow limiting (less severe) based upon the amount of the blood that is flowing into the vessel wall.
measure: Hematoma
time frame: Average of 90 minutes
description: Presence of intramural hematoma on OCT.
A hematoma can be visually observed on a angiogram and an OCT image. The images will be independently reviewed by a core lab expert who will document if a hematoma is present or not.
measure: Optimal PTA
time frame: Average of 90 minutes
description: Achievement of Optimal PTA (<30% Diameter stenosis without flow limiting dissection)
<30% Diameter stenosis and flow limiting dissections are visual assessments that will be conducted by an independent core lab review. The % diameter stenosis measures the amount of plaque that is in the vessel and a flow-limiting dissection is observed as either present or not present.
arm group label: Chocolate PTA Balloon
arm group type: Experimental
description: Chocolate PTA Balloon Angioplasty
arm group label: Standard PTA Balloon
arm group type: Active Comparator
description: Standard PTA Balloon Angioplasty
intervention type: Device
intervention name: Chocolate PTA Balloon Angioplasty
description: OCT imaging of diseased vessel is treated with an Angioplasty Procedure using the Chocolate PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later
arm group label: Chocolate PTA Balloon
intervention type: Device
intervention name: Standard PTA Balloon Angioplasty
description: OCT imaging of diseased vessel is treated with an Angioplasty Procedure using a standard PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later
arm group label: Standard PTA Balloon
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sahil A Parikh, MD
role: Principal Investigator
affiliation: Harrington Heart and Vascular Institute University Hospitals Case Medical Center
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases