<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/NCT01667757</url>
  </required_header>
  <id_info>
    <org_study_id>IB-2-1208-026</org_study_id>
    <nct_id>NCT01667757</nct_id>
  </id_info>
  <brief_title>Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent Implantation</brief_title>
  <official_title>Angiographic and IVUS Criteria Defining Physiologic Optimization By the Fractional Flow Reserve After DES Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Inje University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Invasive imaging criteria of the Coronary arteriography (CAG) and intravascular ultrasound&#xD;
      imaging (IVUS), satisfying procedural optimization after drug eluting stent (DES)&#xD;
      implantation, were used in &lt; 10% DS by CAG and 5-5.5mm2 MSA by IVUS. Whether these criteria&#xD;
      satisfy not only relieving visible stenosis but also relieving lesion specific ischemia or&#xD;
      not were unclear. Fractional flow reserve (FFR), an index of lesion specific ischemia, was&#xD;
      proposed 0.9 as a physiologic criteria satisfying successful stent implantation by previous&#xD;
      studies with bare metal stent. FFR after drug-eluting stent implantation can be an useful&#xD;
      predictor for clinical outcome. But, direct comparative evaluation of the invasive imaging&#xD;
      criteria defining as an indicator relieving myocardial ischemia were not reported. The aim of&#xD;
      this study was to investigate angiographic and IVUS parameters in which corresponding FFR and&#xD;
      evaluate their optimal physiologic criteria after DES implantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Differences angiographic and IVUS parameters after DES between different FFR groups</measure>
    <time_frame>baseline</time_frame>
    <description>Angiographic residual percent diameter stenosis (%), minimal stent lumen diameter (mm) and total stent length (mm), and IVUS minimal stent cross-sectional area (mm2) and minimal stent lumen diameter (mm) will be compared according to different FFR groups at the time of measurement after DES implantation.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Coronary Disease</condition>
  <arm_group>
    <arm_group_label>low post DES FFR group (&lt;0.9)</arm_group_label>
    <description>the patient with FFR values less than 0.9 after DES procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high post DES FFR group (≥0.9)</arm_group_label>
    <description>the patient with FFR values greater than 0.9 after DES procedure</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent coronary angiography and percutaneous coronary intervention for the&#xD;
        diagnosis and treatment purposes because of clinical angina pectoris. Patient who underwent&#xD;
        simultaneous IVUS and FFR measurement after DES implantation would be enrolled&#xD;
        consecutively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical angina pectoris who underwent IVUS and FFR during coronary angiography and&#xD;
             after DES implantation.&#xD;
&#xD;
          -  agree with informed consent&#xD;
&#xD;
          -  At least one segment of three major epicardial coronary arteries were consecutively&#xD;
             enrolled in invasive CAG.&#xD;
&#xD;
          -  Post- stent FFR and IVUS measurement performed at the immediately after whole PCI&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to get informed consent&#xD;
&#xD;
          -  low left ventricular ejection fraction less than 35%&#xD;
&#xD;
          -  chronic renal failure (Cr &gt; 2.0mg/dl)&#xD;
&#xD;
          -  acute myocardial infarction related coronary artery&#xD;
&#xD;
          -  allergy to adenosine injection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joon Hyung Doh, MDPhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inje University Ilsan Paik Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inje University Ilsan Paik Hospital</name>
      <address>
        <city>Goyang</city>
        <state>Gyeonggido</state>
        <zip>411-709</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Sonoda S, Morino Y, Ako J, Terashima M, Hassan AH, Bonneau HN, Leon MB, Moses JW, Yock PG, Honda Y, Kuntz RE, Fitzgerald PJ; SIRIUS Investigators. Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantation: serial intravascular ultrasound analysis from the sirius trial. J Am Coll Cardiol. 2004 Jun 2;43(11):1959-63. doi: 10.1016/j.jacc.2004.01.044.</citation>
    <PMID>15172398</PMID>
  </reference>
  <reference>
    <citation>Doi H, Maehara A, Mintz GS, Yu A, Wang H, Mandinov L, Popma JJ, Ellis SG, Grube E, Dawkins KD, Weissman NJ, Turco MA, Ormiston JA, Stone GW. Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxel-eluting stents: an integrated intravascular ultrasound analysis from the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials. JACC Cardiovasc Interv. 2009 Dec;2(12):1269-75. doi: 10.1016/j.jcin.2009.10.005.</citation>
    <PMID>20129555</PMID>
  </reference>
  <reference>
    <citation>Nam CW, Rha SW, Koo BK, Doh JH, Chung WY, Yoon MH, Tahk SJ, Lee BK, Lee JB, Yoo KD, Cho YK, Chung IS, Hur SH, Kim KB, Choi CU, Oh DJ. Usefulness of coronary pressure measurement for functional evaluation of drug-eluting stent restenosis. Am J Cardiol. 2011 Jun 15;107(12):1783-6. doi: 10.1016/j.amjcard.2011.02.328. Epub 2011 Apr 8.</citation>
    <PMID>21481824</PMID>
  </reference>
  <reference>
    <citation>Nam CW, Hur SH, Cho YK, Park HS, Yoon HJ, Kim H, Chung IS, Kim YN, Kim KB, Doh JH, Koo BK, Tahk SJ, Fearon WF. Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes. Am J Cardiol. 2011 Jun 15;107(12):1763-7. doi: 10.1016/j.amjcard.2011.02.329. Epub 2011 Apr 8.</citation>
    <PMID>21481828</PMID>
  </reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>March 23, 2015</last_update_submitted>
  <last_update_submitted_qc>March 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inje University</investigator_affiliation>
    <investigator_full_name>Joon Hyung Doh</investigator_full_name>
    <investigator_title>MD, PHD</investigator_title>
  </responsible_party>
  <keyword>coronary atherosclerosis</keyword>
  <keyword>drug eluting stent</keyword>
  <keyword>intravascular ultrasound</keyword>
  <keyword>fractional flow reserve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary 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/NCT01667757
org study id: IB-2-1208-026
nct id: NCT01667757
lead sponsor: 
collaborator: 
has dmc: Yes
Invasive imaging criteria of the Coronary arteriography (CAG) and intravascular ultrasound
      imaging (IVUS), satisfying procedural optimization after drug eluting stent (DES)
      implantation, were used in < 10% DS by CAG and 5-5.5mm2 MSA by IVUS. Whether these criteria
      satisfy not only relieving visible stenosis but also relieving lesion specific ischemia or
      not were unclear. Fractional flow reserve (FFR), an index of lesion specific ischemia, was
      proposed 0.9 as a physiologic criteria satisfying successful stent implantation by previous
      studies with bare metal stent. FFR after drug-eluting stent implantation can be an useful
      predictor for clinical outcome. But, direct comparative evaluation of the invasive imaging
      criteria defining as an indicator relieving myocardial ischemia were not reported. The aim of
      this study was to investigate angiographic and IVUS parameters in which corresponding FFR and
      evaluate their optimal physiologic criteria after DES implantation.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Differences angiographic and IVUS parameters after DES between different FFR groups
time frame: baseline
description: Angiographic residual percent diameter stenosis (%), minimal stent lumen diameter (mm) and total stent length (mm), and IVUS minimal stent cross-sectional area (mm2) and minimal stent lumen diameter (mm) will be compared according to different FFR groups at the time of measurement after DES implantation.
arm group label: low post DES FFR group (<0.9)
description: the patient with FFR values less than 0.9 after DES procedure
arm group label: high post DES FFR group (≥0.9)
description: the patient with FFR values greater than 0.9 after DES procedure
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Joon Hyung Doh, MDPhD
role: Principal Investigator
affiliation: Inje University Ilsan Paik Hospital
facility: 
country: Korea, Republic of
citation: Sonoda S, Morino Y, Ako J, Terashima M, Hassan AH, Bonneau HN, Leon MB, Moses JW, Yock PG, Honda Y, Kuntz RE, Fitzgerald PJ; SIRIUS Investigators. Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantation: serial intravascular ultrasound analysis from the sirius trial. J Am Coll Cardiol. 2004 Jun 2;43(11):1959-63. doi: 10.1016/j.jacc.2004.01.044.
PMID: 15172398
citation: Doi H, Maehara A, Mintz GS, Yu A, Wang H, Mandinov L, Popma JJ, Ellis SG, Grube E, Dawkins KD, Weissman NJ, Turco MA, Ormiston JA, Stone GW. Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxel-eluting stents: an integrated intravascular ultrasound analysis from the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials. JACC Cardiovasc Interv. 2009 Dec;2(12):1269-75. doi: 10.1016/j.jcin.2009.10.005.
PMID: 20129555
citation: Nam CW, Rha SW, Koo BK, Doh JH, Chung WY, Yoon MH, Tahk SJ, Lee BK, Lee JB, Yoo KD, Cho YK, Chung IS, Hur SH, Kim KB, Choi CU, Oh DJ. Usefulness of coronary pressure measurement for functional evaluation of drug-eluting stent restenosis. Am J Cardiol. 2011 Jun 15;107(12):1783-6. doi: 10.1016/j.amjcard.2011.02.328. Epub 2011 Apr 8.
PMID: 21481824
citation: Nam CW, Hur SH, Cho YK, Park HS, Yoon HJ, Kim H, Chung IS, Kim YN, Kim KB, Doh JH, Koo BK, Tahk SJ, Fearon WF. Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes. Am J Cardiol. 2011 Jun 15;107(12):1763-7. doi: 10.1016/j.amjcard.2011.02.329. Epub 2011 Apr 8.
PMID: 21481828
responsible party type: Principal Investigator
investigator affiliation: Inje University
investigator full name: Joon Hyung Doh
investigator title: MD, PHD
mesh term: Coronary Disease