<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/NCT04483791</url>
  </required_header>
  <id_info>
    <org_study_id>ELX-CL-2001</org_study_id>
    <nct_id>NCT04483791</nct_id>
  </id_info>
  <brief_title>DynamX Bioadaptor Hong Kong Registry</brief_title>
  <official_title>A Non-Randomized, Clinical Registry of the Dynamx Novolimus Eluting Coronary Bioadaptor System in the Treatment of Patients With De Novo Native Coronary Artery Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elixir Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Elixir Medical 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_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, non-randomized, multicenter registry&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Enrollment of up to 50 subjects with up to two de novo native coronary artery lesions&#xD;
      measuring between 2.25 and 3.5 mm in diameter and&lt;=34 mm in length receiving the DynamX&#xD;
      Novolimus Eluting Coronary Bioadaptor System (CSS), with primary, interim clinical follow-up&#xD;
      via telephone at 1 month. Follow-up will continue at 6, and 12 months. to capture&#xD;
      cardiovascular related hospitalizations related to the study devic&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2020</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective, non-randomized, multicenter registry</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute Device Success</measure>
    <time_frame>procedure</time_frame>
    <description>Percentage of patients with an attainment of a final result of &lt; 30% residual stenosis using the DynamX bioadaptor with standard pre-dilatation and post-dilatation (if applicable) catheters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Device Oriented Clinical Endpoint</measure>
    <time_frame>6 months</time_frame>
    <description>the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device Oriented Clinical Endpoint</measure>
    <time_frame>1 month</time_frame>
    <description>the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Oriented Clinical Endpoint</measure>
    <time_frame>12 months</time_frame>
    <description>the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>death</measure>
    <time_frame>1 month</time_frame>
    <description>cardiac and non-cardiac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>death</measure>
    <time_frame>6 months</time_frame>
    <description>cardiac and non-cardiac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>death</measure>
    <time_frame>12 months</time_frame>
    <description>cardiac and non-cardiac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial infarction</measure>
    <time_frame>1 month</time_frame>
    <description>target vessel and non-target vessel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial infarction</measure>
    <time_frame>6 months</time_frame>
    <description>target vessel and non-target vessel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial infarction</measure>
    <time_frame>12 months</time_frame>
    <description>target vessel and non-target vessel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>target lesion revascularization</measure>
    <time_frame>1 month</time_frame>
    <description>clinically-indicated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>target lesion revascularization</measure>
    <time_frame>6 month</time_frame>
    <description>clinically-indicated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>target lesion revascularization</measure>
    <time_frame>12 month</time_frame>
    <description>clinically-indicated</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>DynamX Novolimus Eluting Coronary Bioadaptor System</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>DynamX use in de novo coronary artery lesions</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>DynamX Novolimus Eluting Coronary Bioadaptor System</intervention_name>
    <description>up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and&lt;=34 mm in length receiving the DynamX Novolimus Eluting Coronary Bioadaptor System</description>
    <arm_group_label>DynamX Novolimus Eluting Coronary Bioadaptor System</arm_group_label>
    <other_name>Novolimus</other_name>
    <other_name>Bioadaptor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject age ≥ 18 and ≤ 80 years&#xD;
&#xD;
          2. Subject (or legal guardian) understands the trial requirements and treatment&#xD;
             procedures and provides written informed consent prior to any trial-specific tests or&#xD;
             treatment&#xD;
&#xD;
          3. Indication for a percutaneous intervention with stent implantation in native&#xD;
             epicardial arteries including patients with stable coronary artery disease and acute&#xD;
             coronary syndromes (non-ST-elevated myocardial infarction)&#xD;
&#xD;
          4. Vessel diameter (2.25-3.5 mm) and lesions length ≤ 34 mm suitable for implantation&#xD;
             using a single stent per lesion&#xD;
&#xD;
          5. All lesions requiring PCI should be amendable for implantation with the study stent&#xD;
&#xD;
          6. Successful pre-dilatation of the first lesion defined as no waist in the inflated&#xD;
             pre-dilatation balloon using two orthogonal views using a pre- dilatation balloon&#xD;
             diameter size ranging from the reference vessel diameter to 0.25 mm smaller than the&#xD;
             reference vessel diameter, and a residual diameter stenosis prior to study device&#xD;
             implantation by visual estimate being &lt; 35%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Target lesion / vessel specific&#xD;
&#xD;
               1. Lesions in the left main&#xD;
&#xD;
               2. Venous or arterial bypass grafts&#xD;
&#xD;
               3. In-stent restenosis&#xD;
&#xD;
               4. Chronic total occlusion&#xD;
&#xD;
               5. Ostial lesions (&lt; 3 mm from the ostium of the RCA, LAD or Cx)&#xD;
&#xD;
               6. Stent implanted &lt; 10 mm from the target lesion in the previous 30 days.&#xD;
&#xD;
               7. Lesion requiring rotablation or atherectomy because of, but not limited to severe&#xD;
                  calcification&#xD;
&#xD;
               8. Bifurcation lesions requiring a planned 2 or more stent technique&#xD;
&#xD;
          2. Patient specific:&#xD;
&#xD;
               1. STEMI&#xD;
&#xD;
               2. Acute myocardial infarction with Killip Class III and IV&#xD;
&#xD;
               3. Known LVEF &lt; 30%&#xD;
&#xD;
               4. Life expectancy &lt; 1 year&#xD;
&#xD;
               5. Patients on renal dialysis or known GFR &lt; 30 ml/min&#xD;
&#xD;
          3. Planned surgery necessitating interruption of dual antiplatelet therapy within the&#xD;
             first 6 months&#xD;
&#xD;
          4. Known intolerance to components of the investigational product or medication required&#xD;
             (e.g. intolerance to concomitant anticoagulation or antiplatelet therapy)&#xD;
&#xD;
          5. Subject is receiving or will require chronic anticoagulation therapy (e.g. coumadin,&#xD;
             dabigatran, apixaban, rivaroxaban, edoxaban or low molecular weight heparin)&#xD;
&#xD;
          6. Subject is currently participating in another clinical trial with an investigational&#xD;
             drug or device that has not yet completed its primary endpoint&#xD;
&#xD;
          7. Known pregnancy or breastfeeding&#xD;
&#xD;
          8. Subject is in the opinion of the Investigator or designee, unable to comply with the&#xD;
             requirements of the study protocol or is unsuitable for the study for any reason&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kwong Wah Hospital</name>
      <address>
        <city>Hong Kong</city>
        <state>Kowloon</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Hong Kong</city>
        <state>Kowloon</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <state>Pok Fu Lam</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese University of Hong Kong / Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <state>Sha Tin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>drug eluting stent</keyword>
  <keyword>percutaneous coronary intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT04483791
org study id: ELX-CL-2001
nct id: NCT04483791
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
Prospective, non-randomized, multicenter registry
Enrollment of up to 50 subjects with up to two de novo native coronary artery lesions
      measuring between 2.25 and 3.5 mm in diameter and<=34 mm in length receiving the DynamX
      Novolimus Eluting Coronary Bioadaptor System (CSS), with primary, interim clinical follow-up
      via telephone at 1 month. Follow-up will continue at 6, and 12 months. to capture
      cardiovascular related hospitalizations related to the study devic
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, non-randomized, multicenter registry
primary purpose: Other
masking: None (Open Label)
measure: Acute Device Success
time frame: procedure
description: Percentage of patients with an attainment of a final result of < 30% residual stenosis using the DynamX bioadaptor with standard pre-dilatation and post-dilatation (if applicable) catheters
measure: Device Oriented Clinical Endpoint
time frame: 6 months
description: the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
measure: Device Oriented Clinical Endpoint
time frame: 1 month
description: the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
measure: Device Oriented Clinical Endpoint
time frame: 12 months
description: the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
measure: death
time frame: 1 month
description: cardiac and non-cardiac
measure: death
time frame: 6 months
description: cardiac and non-cardiac
measure: death
time frame: 12 months
description: cardiac and non-cardiac
measure: myocardial infarction
time frame: 1 month
description: target vessel and non-target vessel
measure: myocardial infarction
time frame: 6 months
description: target vessel and non-target vessel
measure: myocardial infarction
time frame: 12 months
description: target vessel and non-target vessel
measure: target lesion revascularization
time frame: 1 month
description: clinically-indicated
measure: target lesion revascularization
time frame: 6 month
description: clinically-indicated
measure: target lesion revascularization
time frame: 12 month
description: clinically-indicated
arm group label: DynamX Novolimus Eluting Coronary Bioadaptor System
arm group type: Other
description: DynamX use in de novo coronary artery lesions
intervention type: Combination Product
intervention name: DynamX Novolimus Eluting Coronary Bioadaptor System
description: up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and<=34 mm in length receiving the DynamX Novolimus Eluting Coronary Bioadaptor System
arm group label: DynamX Novolimus Eluting Coronary Bioadaptor System
other name: Novolimus
other name: Bioadaptor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: No