<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/NCT02219594</url>
  </required_header>
  <id_info>
    <org_study_id>W201310</org_study_id>
    <nct_id>NCT02219594</nct_id>
  </id_info>
  <brief_title>The Comparative Study of OCT，Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent</brief_title>
  <official_title>The Comparative Study of OCT，Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuzhou Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xuzhou Central Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In-stent restenosis is a major reason of coronary heart disease recurrence .Even in drug&#xD;
      eluting stent(DES), Restenosis rate could be up to 10% in diabetes and complex lesions though&#xD;
      it was about 3-5% in general. It is particularly important that in-stent restenosis after&#xD;
      implantation was early diagnosed and detected. The evaluation of OCT imaging is more accurate&#xD;
      for narrow area calculation, more clear for narrow organization structure and more specific&#xD;
      for detecting tissue types.It is currently the best way for restenosis histologic&#xD;
      diagnosis.But it has many weakness such as the higher cost,an invasive test, expensive&#xD;
      instrument, relatively complicated to operate,and etc.In this study, OCT image was regard as&#xD;
      the &quot;gold standard&quot; of stent restenosis.&#xD;
&#xD;
      The improvement of spatial resolution of Gemstone CT can effectively improve the imaging&#xD;
      quality and the measurement's accuracy of coronary artery stents.The diagnostic value of&#xD;
      in-stent restenosis of Gemstone CT is higher than of the 320-detector row spiral CT. To a&#xD;
      certain extent, the gemstone CT can replace OCT for examining the in-stent restenosis.&#xD;
&#xD;
      This study will examine the degree of in-stent restenosis by the gemstone CT and the&#xD;
      320-detector row spiral CT and compare the two ways on the basis of the result of OCT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2016</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of detection of in-stent restenosis with the gemstone CT as compared to the 320-detector row spiral CT will be investigated</measure>
    <time_frame>On the day in which a patient receives the gemstone CT and the 320-detector row spiral CT, estimated to take 10 mins</time_frame>
    <description>Masked examiners (CT specialists) will evaluate and compare the degree of in-stent restenosis of the gemstone CT and the 320-detector row spiral CT images for the presence and features of in-stent restenosis. In this study, OCT image was regard as the &quot;gold standard&quot; of in-stent restenosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiation burden of the the gemstone CT or the 320-detector row spiral CT and OCT</measure>
    <time_frame>one month</time_frame>
    <description>In a relatively short time,the patient will accept the two checks of CT and OCT(Interval period about 10 days).So,it is necessary to clear the reacts of these patients</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Measurement of the physical characteristics of in-stent restenosis structures seen on OCT</measure>
    <time_frame>On the day in which a patient receives the check of OCT</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Coronary Heart Disease</condition>
  <arm_group>
    <arm_group_label>Gemstone CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gemstone CT ：Discovery CT750 HD（high definition） ，GE（General Electric Co.） Healthcare, Milwaukee； CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>320-detector row spiral CT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>320-detector row spiral CT：Aquilion One, Toshiba, Nasu, Japan. CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient .</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CT image for patient with suspected in-stent restenosis</intervention_name>
    <description>Gemstone CT or 320-detector row spiral CT was assigned randomly to patient who was suspected in-stent restenosis.About after 10 days,they would accept the check of OCT which wold be the &quot;gold standard&quot; of in-stent restenosis.</description>
    <arm_group_label>320-detector row spiral CT</arm_group_label>
    <arm_group_label>Gemstone CT</arm_group_label>
    <other_name>Gemstone CT</other_name>
    <other_name>320-detector row spiral CT</other_name>
    <other_name>OCT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 20-80， All genders&#xD;
&#xD;
          2. Unlimited time of implantation of coronary artery stents&#xD;
&#xD;
          3. Myocardial ischemia symptoms such as Chest tightness and/or chest pain in patients&#xD;
             after stent implantation&#xD;
&#xD;
          4. No clinical symptoms, but myocardial ischemia suggested by other noninvasive tests&#xD;
&#xD;
          5. Routine re-testing 9-12 months after stent implantation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Renal insufficiency (serum creatinine &gt; 120 umol/L)&#xD;
&#xD;
          2. Allergy of contrast&#xD;
&#xD;
          3. Severe heart failure&#xD;
&#xD;
          4. Uncontrollable heart rate or contraindication of taking metoprolol&#xD;
&#xD;
          5. Unstable condition&#xD;
&#xD;
          6. the ventricular rate beyond 70 beats / min and irregular rhythm after adjusting.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Institute of Cardiovascular Disease Xuzhou Central Hospital</last_name>
    <role>Study Director</role>
    <affiliation>Southeast University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Feng chunguang, PhD</last_name>
    <phone>+8618936376559</phone>
    <email>fcg999@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xuzhou Central Hospital</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <zip>221000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng chunguang, PhD</last_name>
      <phone>+8618936376559</phone>
      <email>fcg999@163.com</email>
    </contact>
    <investigator>
      <last_name>Feng chunguang, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Colombo A, Latib A. [Treatment of drug-eluting stent restenosis with another drug-eluting stent: do not fail the second time!]. Rev Esp Cardiol. 2008 Nov;61(11):1120-2. No abstract available. Spanish.</citation>
    <PMID>19000485</PMID>
  </reference>
  <reference>
    <citation>Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.</citation>
    <PMID>18765162</PMID>
  </reference>
  <reference>
    <citation>Pasterkamp G, Falk E, Woutman H, Borst C. Techniques characterizing the coronary atherosclerotic plaque: influence on clinical decision making? J Am Coll Cardiol. 2000 Jul;36(1):13-21. doi: 10.1016/s0735-1097(00)00677-x.</citation>
    <PMID>10898406</PMID>
  </reference>
  <reference>
    <citation>Chau AH, Chan RC, Shishkov M, MacNeill B, Iftimia N, Tearney GJ, Kamm RD, Bouma BE, Kaazempur-Mofrad MR. Mechanical analysis of atherosclerotic plaques based on optical coherence tomography. Ann Biomed Eng. 2004 Nov;32(11):1494-503. doi: 10.1114/b:abme.0000049034.75368.4a.</citation>
    <PMID>15636110</PMID>
  </reference>
  <reference>
    <citation>Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dubel HP, Schlattmann P, Knebel F, Rutsch W, Hamm B. Noninvasive coronary angiography by 320-row computed tomography with lower radiation exposure and maintained diagnostic accuracy: comparison of results with cardiac catheterization in a head-to-head pilot investigation. Circulation. 2009 Sep 8;120(10):867-75. doi: 10.1161/CIRCULATIONAHA.109.859280. Epub 2009 Aug 24.</citation>
    <PMID>19704093</PMID>
  </reference>
  <results_reference>
    <citation>Manfrini O,Slueea M,Bugiardinl R.Optical coherence tomography[J].G ltal Cardiol(Rome)，2007,8(1):28-33．</citation>
  </results_reference>
  <results_reference>
    <citation>Andreini D，Pontone G，Mushtaq S，et a1．Multidetector computed tomography coronary angiography for the assessment of coronary in-stent restenosis．Am J Cardiol，2010,105:645.</citation>
  </results_reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 10, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gemstone CT</keyword>
  <keyword>320-detector row spiral CT</keyword>
  <keyword>optical coherence tomography(OCT)</keyword>
  <keyword>in-stent restenosis</keyword>
  <keyword>coronary heart disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</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/NCT02219594
org study id: W201310
nct id: NCT02219594
lead sponsor: 
has dmc: Yes
In-stent restenosis is a major reason of coronary heart disease recurrence .Even in drug
      eluting stent(DES), Restenosis rate could be up to 10% in diabetes and complex lesions though
      it was about 3-5% in general. It is particularly important that in-stent restenosis after
      implantation was early diagnosed and detected. The evaluation of OCT imaging is more accurate
      for narrow area calculation, more clear for narrow organization structure and more specific
      for detecting tissue types.It is currently the best way for restenosis histologic
      diagnosis.But it has many weakness such as the higher cost,an invasive test, expensive
      instrument, relatively complicated to operate,and etc.In this study, OCT image was regard as
      the "gold standard" of stent restenosis.

      The improvement of spatial resolution of Gemstone CT can effectively improve the imaging
      quality and the measurement's accuracy of coronary artery stents.The diagnostic value of
      in-stent restenosis of Gemstone CT is higher than of the 320-detector row spiral CT. To a
      certain extent, the gemstone CT can replace OCT for examining the in-stent restenosis.

      This study will examine the degree of in-stent restenosis by the gemstone CT and the
      320-detector row spiral CT and compare the two ways on the basis of the result of OCT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Accuracy of detection of in-stent restenosis with the gemstone CT as compared to the 320-detector row spiral CT will be investigated
time frame: On the day in which a patient receives the gemstone CT and the 320-detector row spiral CT, estimated to take 10 mins
description: Masked examiners (CT specialists) will evaluate and compare the degree of in-stent restenosis of the gemstone CT and the 320-detector row spiral CT images for the presence and features of in-stent restenosis. In this study, OCT image was regard as the "gold standard" of in-stent restenosis.
measure: Radiation burden of the the gemstone CT or the 320-detector row spiral CT and OCT
time frame: one month
description: In a relatively short time,the patient will accept the two checks of CT and OCT(Interval period about 10 days).So,it is necessary to clear the reacts of these patients
measure: Measurement of the physical characteristics of in-stent restenosis structures seen on OCT
time frame: On the day in which a patient receives the check of OCT
arm group label: Gemstone CT
arm group type: Experimental
description: Gemstone CT ：Discovery CT750 HD（high definition） ，GE（General Electric Co.） Healthcare, Milwaukee； CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient
arm group label: 320-detector row spiral CT
arm group type: Active Comparator
description: 320-detector row spiral CT：Aquilion One, Toshiba, Nasu, Japan. CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient .
intervention type: Device
intervention name: CT image for patient with suspected in-stent restenosis
description: Gemstone CT or 320-detector row spiral CT was assigned randomly to patient who was suspected in-stent restenosis.About after 10 days,they would accept the check of OCT which wold be the "gold standard" of in-stent restenosis.
arm group label: 320-detector row spiral CT
arm group label: Gemstone CT
other name: Gemstone CT
other name: 320-detector row spiral CT
other name: OCT
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Institute of Cardiovascular Disease Xuzhou Central Hospital
role: Study Director
affiliation: Southeast University
last name: Feng chunguang, PhD
phone: +8618936376559
email: fcg999@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
citation: Colombo A, Latib A. [Treatment of drug-eluting stent restenosis with another drug-eluting stent: do not fail the second time!]. Rev Esp Cardiol. 2008 Nov;61(11):1120-2. No abstract available. Spanish.
PMID: 19000485
citation: Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.
PMID: 18765162
citation: Pasterkamp G, Falk E, Woutman H, Borst C. Techniques characterizing the coronary atherosclerotic plaque: influence on clinical decision making? J Am Coll Cardiol. 2000 Jul;36(1):13-21. doi: 10.1016/s0735-1097(00)00677-x.
PMID: 10898406
citation: Chau AH, Chan RC, Shishkov M, MacNeill B, Iftimia N, Tearney GJ, Kamm RD, Bouma BE, Kaazempur-Mofrad MR. Mechanical analysis of atherosclerotic plaques based on optical coherence tomography. Ann Biomed Eng. 2004 Nov;32(11):1494-503. doi: 10.1114/b:abme.0000049034.75368.4a.
PMID: 15636110
citation: Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dubel HP, Schlattmann P, Knebel F, Rutsch W, Hamm B. Noninvasive coronary angiography by 320-row computed tomography with lower radiation exposure and maintained diagnostic accuracy: comparison of results with cardiac catheterization in a head-to-head pilot investigation. Circulation. 2009 Sep 8;120(10):867-75. doi: 10.1161/CIRCULATIONAHA.109.859280. Epub 2009 Aug 24.
PMID: 19704093
citation: Manfrini O,Slueea M,Bugiardinl R.Optical coherence tomography[J].G ltal Cardiol(Rome)，2007,8(1):28-33．
citation: Andreini D，Pontone G，Mushtaq S，et a1．Multidetector computed tomography coronary angiography for the assessment of coronary in-stent restenosis．Am J Cardiol，2010,105:645.
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia