<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/NCT04482972</url>
  </required_header>
  <id_info>
    <org_study_id>195002</org_study_id>
    <nct_id>NCT04482972</nct_id>
  </id_info>
  <brief_title>Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty</brief_title>
  <official_title>Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norfolk and Norwich University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of East Anglia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norfolk and Norwich University Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Drug coated balloon (DCB) is a relatively new technology which allows the treatment of&#xD;
      coronary artery disease without permanent implantation of a metallic scaffold (stent) in the&#xD;
      coronary artery. It is recommended by international guidelines for the treatment of in-stent&#xD;
      restenosis (i.e. when a previously implanted stent in the coronary artery develops narrowings&#xD;
      again). Data on patient outcomes of patients treated with DCB for de novo coronary artery&#xD;
      disease (narrowings in artery supplying blood to the heart that has not been previously&#xD;
      treated with a stent) are limited to relatively small studies. In our institution, DCBs have&#xD;
      been used over the last 10 years and we have developed a large clinical database. We intend&#xD;
      to compare the outcomes of all our patients treated clinically with DCB vs patients treated&#xD;
      with drug eluting stent (DES). We will, incorporate all patients presenting either with&#xD;
      myocardial infarction (heart attack) or stable angina. Our main outcomes will be: Primary 1)&#xD;
      mortality Secondary 1) cardiac mortality 2) cardiac rehospitalisation3) composite of cardiac&#xD;
      mortality and cardiac rehospitalisation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2009</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Actual">November 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>Through study completion, an average of 10 years</time_frame>
    <description>All cause death will be defined as death due to any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiac mortality - either MI, TVR, Acute Vessel Closure or TLR</measure>
    <time_frame>Through study completion, an average of 10 years</time_frame>
    <description>An MI is defined as per MINAP definition (a hospital diagnosis reported as a troponin positive MI). A TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The latter is defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.&#xD;
Acute vessel closure is defined as an event where a patient had to be taken back to cardiac catheterisation lab and require repeat angioplasty (during the same hospital stay) for a complete or partial occlusion of the artery due to a dissection.&#xD;
A TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal and 5 mm distal to the treated lesion (by visual assessment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac rehospitalisation</measure>
    <time_frame>Through study completion, an average of 10 years</time_frame>
    <description>Any hospital record of admission due to cardiac complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of cardiac death and cardiac rehospitalisation</measure>
    <time_frame>Through study completion, an average of 10 years</time_frame>
    <description>Any hospital record of admission and death due to cardiac complications</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>DCB</arm_group_label>
    <description>DCB group: Patients treated with drug coated balloon (DCB) only angioplasty (all-comers: STEMI, NSTEMI, Stable angina)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DES</arm_group_label>
    <description>DES group: Patients treated with drug eluting stent (DES) angioplasty (all-comers:STEMI, NSTEMI, Stable angina)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>DCB</intervention_name>
    <description>Angioplasty with DCB is an angioplasty technique which allows drug delivery to the coronary artery without stent implantation.</description>
    <arm_group_label>DCB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>DES</intervention_name>
    <description>Angioplasty with DES is an angioplasty technique which permits drug delivery to the coronary artery and permanent implantation of a stent.</description>
    <arm_group_label>DES</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at Norfolk and Norwich University Hospitals NHS foundation trust&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patients with coronary artery disease being treated with DCB or DES&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simon C Eccleshall</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norfolk and Norwich University Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Norfolk and Norwich University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Norwich</city>
        <state>Norfolk</state>
        <zip>NR4 7UY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.</citation>
    <PMID>32473887</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>March 31, 2022</last_update_submitted>
  <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug coated balloon</keyword>
  <keyword>Drug eluting stent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT04482972
org study id: 195002
nct id: NCT04482972
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Drug coated balloon (DCB) is a relatively new technology which allows the treatment of
      coronary artery disease without permanent implantation of a metallic scaffold (stent) in the
      coronary artery. It is recommended by international guidelines for the treatment of in-stent
      restenosis (i.e. when a previously implanted stent in the coronary artery develops narrowings
      again). Data on patient outcomes of patients treated with DCB for de novo coronary artery
      disease (narrowings in artery supplying blood to the heart that has not been previously
      treated with a stent) are limited to relatively small studies. In our institution, DCBs have
      been used over the last 10 years and we have developed a large clinical database. We intend
      to compare the outcomes of all our patients treated clinically with DCB vs patients treated
      with drug eluting stent (DES). We will, incorporate all patients presenting either with
      myocardial infarction (heart attack) or stable angina. Our main outcomes will be: Primary 1)
      mortality Secondary 1) cardiac mortality 2) cardiac rehospitalisation3) composite of cardiac
      mortality and cardiac rehospitalisation
observational model: Cohort
time perspective: Retrospective
measure: All-cause mortality
time frame: Through study completion, an average of 10 years
description: All cause death will be defined as death due to any cause
measure: Cardiac mortality - either MI, TVR, Acute Vessel Closure or TLR
time frame: Through study completion, an average of 10 years
description: An MI is defined as per MINAP definition (a hospital diagnosis reported as a troponin positive MI). A TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The latter is defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.
Acute vessel closure is defined as an event where a patient had to be taken back to cardiac catheterisation lab and require repeat angioplasty (during the same hospital stay) for a complete or partial occlusion of the artery due to a dissection.
A TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal and 5 mm distal to the treated lesion (by visual assessment).
measure: Cardiac rehospitalisation
time frame: Through study completion, an average of 10 years
description: Any hospital record of admission due to cardiac complications
measure: Composite of cardiac death and cardiac rehospitalisation
time frame: Through study completion, an average of 10 years
description: Any hospital record of admission and death due to cardiac complications
arm group label: DCB
description: DCB group: Patients treated with drug coated balloon (DCB) only angioplasty (all-comers: STEMI, NSTEMI, Stable angina)
arm group label: DES
description: DES group: Patients treated with drug eluting stent (DES) angioplasty (all-comers:STEMI, NSTEMI, Stable angina)
intervention type: Procedure
intervention name: DCB
description: Angioplasty with DCB is an angioplasty technique which allows drug delivery to the coronary artery without stent implantation.
arm group label: DCB
intervention type: Procedure
intervention name: DES
description: Angioplasty with DES is an angioplasty technique which permits drug delivery to the coronary artery and permanent implantation of a stent.
arm group label: DES
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Simon C Eccleshall
role: Principal Investigator
affiliation: Norfolk and Norwich University Hospitals NHS Foundation Trust
facility: 
country: United Kingdom
citation: Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.
PMID: 32473887
responsible party type: Sponsor
mesh term: Coronary Artery Disease