<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/NCT02236975</url>
  </required_header>
  <id_info>
    <org_study_id>PIONEER</org_study_id>
    <nct_id>NCT02236975</nct_id>
  </id_info>
  <brief_title>First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis</brief_title>
  <official_title>Prospective, Multi-center, Randomized First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme eG (Electro Grafting) Based Biodegradable Polymer Sirolimus-eluting Stent and Resolute Integrity Zotarolimus-eluting Durable Polymer Stent in Patients With de Novo Coronary Artery Stenosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sino Medical Sciences Technology Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sino Medical Sciences Technology Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus&#xD;
      Resolute Integrity conducted in approximately 14 interventional cardiology centers in The&#xD;
      Netherlands, Belgium, Spain and Portugal.&#xD;
&#xD;
      Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. All patients&#xD;
      will undergo repeat angiography at 9 months follow-up. QCA assessment will be performed at&#xD;
      baseline (pre- and post-procedure) and at 9 months follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>Phase 2/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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Late Lumen Loss</measure>
    <time_frame>Up to 9 month</time_frame>
    <description>The primary endpoint is in-stent Late Lumen Loss (LLL) at 9 months after stent implantation as assessed by off-line QCA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint</measure>
    <time_frame>9 and 12 month</time_frame>
    <description>Acute Lumen Gain (mm);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint</measure>
    <time_frame>9 and 12 month</time_frame>
    <description>MLD (mm) post procedure and at 9 months;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint</measure>
    <time_frame>9 and 12 month</time_frame>
    <description>Diameter Stenosis (%) post procedure and at 9 months;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint</measure>
    <time_frame>9 and 12 month</time_frame>
    <description>Binary Restenosis (DS ≥50%) at 9 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoint</measure>
    <time_frame>9 and 12 month</time_frame>
    <description>Acute success (device and procedural success)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cinical endpoint</measure>
    <time_frame>9 and 12 month</time_frame>
    <description>Device-oriented Composite Endpoints (DoCE) at 1, 9 and 12 months and its individual components. (Device-oriented Composite Endpoint is defined as Cardiac Death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated Target Lesion Revascularization).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoint</measure>
    <time_frame>9 and 12 month</time_frame>
    <description>Myocardial infarction (Q-wave, Non q-wave) at all time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoint</measure>
    <time_frame>9 and 12 month</time_frame>
    <description>Any revascularization at all time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical endpoint</measure>
    <time_frame>9 and 12 month</time_frame>
    <description>Stent thrombosis according to the ARC definitions up to 12 months follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>BuMA Supreme Biodegradable drug coating coronary stent system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implant BuMA Supreme stent only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resolute Integrity durable polymer stent system</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implant Resolute stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BuMA Supreme Biodegradable drug coating coronary stent system</intervention_name>
    <arm_group_label>BuMA Supreme Biodegradable drug coating coronary stent system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Resolute Integrity durable polymer stent system</intervention_name>
    <arm_group_label>Resolute Integrity durable polymer stent system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is at least 18 years of age.&#xD;
&#xD;
          2. Clinical evidence of ischemic heart disease and/or a positive territorial functional&#xD;
             study.&#xD;
&#xD;
          3. Documented stable angina pectoris (Canadian Cardiovascular Society (CCS)&#xD;
             Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia&#xD;
             (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia&#xD;
&#xD;
          4. The patient has a planned intervention of a single de-novo lesion in one or two&#xD;
             separate major epicardial territories (LAD, LCX or RCA).&#xD;
&#xD;
          5. Diameter Stenosis≥50 and&lt;100%.&#xD;
&#xD;
          6. The visually estimated target lesion must be able to be covered by a single BuMA&#xD;
             Supreme stent or a single Resolute Integrity stent (for available sizes refer to&#xD;
             tables 1 and 2, page 20 and 21).&#xD;
&#xD;
          7. The target lesion reference diameter must be visually estimated to be ≥2.5 mm and ≤4.5&#xD;
             mm in diameter.&#xD;
&#xD;
          8. Written informed consent.&#xD;
&#xD;
          9. The patient agrees to the follow-up visits including a 9 month angiographic follow-up.&#xD;
&#xD;
         10. Patient must have completed the follow-up phase of any previous study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female of child bearing potential (age &lt;50 years and last menstruation within the last&#xD;
             12 months). Subjects with age &lt;50 who underwent tubal ligation, ovariectomy or&#xD;
             hysterectomy can be included.&#xD;
&#xD;
          2. Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac&#xD;
             biomarkers (according to local standard hospital practice) have not returned within&#xD;
             normal limits at the time of procedure&#xD;
&#xD;
          3. Patient suffered from stroke/TIA during the last 6 months.&#xD;
&#xD;
          4. LVEF &lt;30%&#xD;
&#xD;
          5. Platelet count &lt;100,000 cells/mm3 or &gt;400,000 cells/mm3, a WBC of &lt;3,000 cells/mm3, or&#xD;
             documented or suspected liver disease (including laboratory evidence of hepatitis)&#xD;
&#xD;
          6. Known renal insufficiency (e.g. serum creatinine &gt;2.5mg/dL, or creatinine clearance&#xD;
             ≤30 mL/min), or subject on dialysis, or acute kidney failure (as per physician&#xD;
             judgment).&#xD;
&#xD;
          7. Patient undergoing planned surgery within 6 months with the necessity to stop DAPT.&#xD;
&#xD;
          8. Patient requiring oral anticoagulation (Coumadin, Novel Oral Anticoagulant (NOAC))&#xD;
&#xD;
          9. History of bleeding diathesis or coagulopathy&#xD;
&#xD;
         10. The patient is a recipient of a heart transplant&#xD;
&#xD;
         11. Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet&#xD;
             medication specified for use in the study, sirolimus, zotarolimus, or cobalt-chromium.&#xD;
&#xD;
         12. Other medical illness (e.g. cancer, stroke with neurological deficiency) or known&#xD;
             history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment&#xD;
             that may cause non-compliance with the protocol or confound the data interpretation or&#xD;
             is associated with a limited life expectancy&#xD;
&#xD;
         13. The patient is simultaneously participating in another investigational device or drug&#xD;
             study&#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>Clemens von.Birgelen, MD,Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medisch Spectrum Twente (MST), Enschede, the Netherlands</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manel Sabate, MD,Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinic university hospital Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patrick W.Serruys, MD,Phd</last_name>
    <role>Study Chair</role>
    <affiliation>Interventional Cardiology, Thorax center, Erasmus MC, Rotterdam</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Imelda Hospital</name>
      <address>
        <city>Bonheiden</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Chaleroi</name>
      <address>
        <city>Chaleroi</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oost-limburg Hospital</name>
      <address>
        <city>Genk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OLVG</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMCG</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maasstad Hospital</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospita; Garcia de Orta</name>
      <address>
        <city>Almada</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Maria University Hospital</name>
      <address>
        <city>Lisboa</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gaia/Espinho Hospital Centers</name>
      <address>
        <city>Oporto</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Madrid</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Álvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 4, 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>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</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>Coronary Stenosis</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/NCT02236975
org study id: PIONEER
nct id: NCT02236975
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus
      Resolute Integrity conducted in approximately 14 interventional cardiology centers in The
      Netherlands, Belgium, Spain and Portugal.

      Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. All patients
      will undergo repeat angiography at 9 months follow-up. QCA assessment will be performed at
      baseline (pre- and post-procedure) and at 9 months follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Late Lumen Loss
time frame: Up to 9 month
description: The primary endpoint is in-stent Late Lumen Loss (LLL) at 9 months after stent implantation as assessed by off-line QCA.
measure: Angiographic endpoint
time frame: 9 and 12 month
description: Acute Lumen Gain (mm);
measure: Angiographic endpoint
time frame: 9 and 12 month
description: MLD (mm) post procedure and at 9 months;
measure: Angiographic endpoint
time frame: 9 and 12 month
description: Diameter Stenosis (%) post procedure and at 9 months;
measure: Angiographic endpoint
time frame: 9 and 12 month
description: Binary Restenosis (DS ≥50%) at 9 months
measure: Clinical endpoint
time frame: 9 and 12 month
description: Acute success (device and procedural success)
measure: Cinical endpoint
time frame: 9 and 12 month
description: Device-oriented Composite Endpoints (DoCE) at 1, 9 and 12 months and its individual components. (Device-oriented Composite Endpoint is defined as Cardiac Death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated Target Lesion Revascularization).
measure: Clinical endpoint
time frame: 9 and 12 month
description: Myocardial infarction (Q-wave, Non q-wave) at all time points.
measure: Clinical endpoint
time frame: 9 and 12 month
description: Any revascularization at all time points.
measure: Clinical endpoint
time frame: 9 and 12 month
description: Stent thrombosis according to the ARC definitions up to 12 months follow-up.
arm group label: BuMA Supreme Biodegradable drug coating coronary stent system
arm group type: Experimental
description: Implant BuMA Supreme stent only
arm group label: Resolute Integrity durable polymer stent system
arm group type: Active Comparator
description: Implant Resolute stent
intervention type: Device
intervention name: BuMA Supreme Biodegradable drug coating coronary stent system
arm group label: BuMA Supreme Biodegradable drug coating coronary stent system
intervention type: Device
intervention name: Resolute Integrity durable polymer stent system
arm group label: Resolute Integrity durable polymer stent system
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clemens von.Birgelen, MD,Phd
role: Principal Investigator
affiliation: Medisch Spectrum Twente (MST), Enschede, the Netherlands
last name: Manel Sabate, MD,Phd
role: Principal Investigator
affiliation: Clinic university hospital Barcelona, Spain
last name: Patrick W.Serruys, MD,Phd
role: Study Chair
affiliation: Interventional Cardiology, Thorax center, Erasmus MC, Rotterdam
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Netherlands
country: Portugal
country: Spain
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Coronary Stenosis