<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/NCT03770650</url>
  </required_header>
  <id_info>
    <org_study_id>NFH20180920</org_study_id>
    <nct_id>NCT03770650</nct_id>
  </id_info>
  <brief_title>IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions</brief_title>
  <acronym>DKCRUSH-VIII</acronym>
  <official_title>Comparison of Intravascular Ultrasound-guided With Angiography-guided Double Kissing Crush Stenting Technique for Patients With Complex Coronary Bifurcation Lesions: The Prospective, Multi-center, Randomized DKCRUSH VIII Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing First Hospital, Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing First Hospital, Nanjing Medical University</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to investigate whether IVUS-guided DK crush stenting technique&#xD;
      compared to angiography-guided DK crush after the indexed procedure will lead to lower rates&#xD;
      of the composite endpoint of target vessel failure (TVF) at 12 months. The individual&#xD;
      components of TVF include cardiac death, target-vessel myocardial infarction (MI), or target&#xD;
      vessel revascularization (TVR). Complex bifurcation lesions were defined according to&#xD;
      DEFINITION study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, randomized-controlled, single blind, superiority trial&#xD;
      that will include 35 international sites. The investigators aim to enroll 556 subjects with&#xD;
      complex coronary bifurcation lesions in native coronary arterial segments.&#xD;
&#xD;
      All patients with complex coronary bifurcation lesions suitable for DES implantation will&#xD;
      undergo 1:1 randomization either to IVUS-guided or angiography-guided DK crush stenting using&#xD;
      a randomization schedule blocked by site.&#xD;
&#xD;
      All subjects will be screened according to the predefined inclusion and exclusion criteria&#xD;
      per protocol and will further undergo angiography before DES implantation. Data and images&#xD;
      will be collected during the index procedure, during re-intervention in the case of&#xD;
      clinically driven TVF, and at the predefined 12-month clinical follow-up visit. All subjects&#xD;
      will also undergo angiographic follow-up at 13 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 26, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2025</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>
    <intervention_model_description>Patients will undergo 1:1 randomization to either IVUS-guided DKCrush stenting which will be the treatment group or Angio-guided DKCrush stenting which will be the control group based on an online Clinical Research Data Management Platform provided by King Yee,,Beijing CN. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1, 6, and 12 months after the index procedure. Angiographic follow-up is scheduled at 13 months.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcomes assessor will remain blinded until the final study results are released.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of target vessel failure</measure>
    <time_frame>12 months after DES implantation</time_frame>
    <description>TVF defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven TVR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of stent thrombosis</measure>
    <time_frame>12 months after DES implantation</time_frame>
    <description>The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">556</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>IVUS-guided DK crush stenting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the IVUS-guided DK crush stenting group, IVUS will be before side branch stenting, after rewiring side branch, after 1st kissing balloon inflation, after rewiring side branch, after 2nd kissing balloon inflation.&#xD;
For LM bifurcation lesions involving ostial LAD and LCX: minimum stent are (MSA) should be ≥10mm2 (LM), 7 mm2 (LAD), and 6 mm2 (LCX), with stent expansion index ≥90% (CSA≥90% of distal reference lumen area in LCX) and symmetry index &gt;0.8.&#xD;
For non-LM bifurcation lesion involving the MSA should be ≥6 mm2 in the main vessel; and the MSA in the ostial side branch should be ≥5 mm2 and ≥90% of distal reference lumen area; and symmetry index should be &gt;0.8.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Angiography-guided DK crush stenting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the Angiography-guided DK crush stenting group, stent diameter and length will be selected by visual estimation with a stent/artery ratio of 1.1:1.0. Post-dilation with a noncompliant balloon (balloon/stent diameter=1.0:1.0) inflated at &gt;18 atm will be performed for all lesions. Angiographic success is defined as Thrombolysis In Myocardial Infarction (TIMI) grade 3, residual stenosis &lt;20%, and the absence of ≥Type B dissection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stenting</intervention_name>
    <description>DK crush technique with SYNERGY (Boston Scientific) drug-eluting stent implantation.</description>
    <arm_group_label>Angiography-guided DK crush stenting</arm_group_label>
    <arm_group_label>IVUS-guided DK crush stenting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent prior to any study specific procedures;&#xD;
&#xD;
          2. Men and women 18 years and older;&#xD;
&#xD;
          3. Established indication for PCI according to the guidelines of ACC/AHA;&#xD;
&#xD;
          4. Native coronary lesion suitable for drug-eluting stent placement;&#xD;
&#xD;
          5. True bifurcation lesions (Medina 0,1,1/1,1,1), lesions length≤ 68 mm&#xD;
&#xD;
          6. Reference vessel diameter in side branch &gt; 2.5mm by visual estimation;&#xD;
&#xD;
          7. Complex bifurcation lesions based on the DEFINITION study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy and breast feeding mother;&#xD;
&#xD;
          2. Co-morbidity with an estimated life expectancy of &lt; 50 % at 12 months;&#xD;
&#xD;
          3. Scheduled surgery interrupting antiplatelet medications in the next 6 months;&#xD;
&#xD;
          4. Intolerable to DAPT;&#xD;
&#xD;
          5. Inability to follow the protocol and comply with follow-up requirements or any other&#xD;
             reason that the investigator feels would place the patient at increased risk;&#xD;
&#xD;
          6. Unable to provide written informed consent, or fail to follow the protocol;&#xD;
&#xD;
          7. Previous enrolment in coronary intervention device investigation during the study&#xD;
             period;&#xD;
&#xD;
          8. Lesion cannot be covered by 2 longest stents;&#xD;
&#xD;
          9. Restenotic bifurcation lesions；&#xD;
&#xD;
         10. Severe calcification requiring rotational atherectomy;&#xD;
&#xD;
         11. Acute myocardial infarction less than 24 hours;&#xD;
&#xD;
         12. Chronic total occlusion which is not recanalized;&#xD;
&#xD;
         13. Simple bifurcation lesions;&#xD;
&#xD;
         14. Renal failure requiring or during dialysis;&#xD;
&#xD;
         15. Hemoglobin &lt;9g/L&#xD;
&#xD;
         16. Uncontrolled hypertension (systolic blood pressure≥180 mmHg or diastolic blood&#xD;
             pressure≥110 mmHg)&#xD;
&#xD;
         17. Severe heart failure (LVEF&lt;30%)&#xD;
&#xD;
         18. Combined pre- and post-capillary hypertension (mPAP≥25 mmHg, PCWP&gt;15 mmHg, and PVR&gt;3.0&#xD;
             WU)&#xD;
&#xD;
         19. Patients with hypertrophic obstructive cardiomyopathy.&#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>Shao-Liang Chen, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Nanjing First Hospital, Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shao-Liang Chen, MD, PhD</last_name>
    <phone>+86-25-52208048</phone>
    <email>chmengx@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jing Kan, MPH</last_name>
    <phone>+86-25-52271398</phone>
    <email>kanjingok@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nanjing First Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shaoliang Chen, MD</last_name>
      <phone>+86 13605157029</phone>
      <email>chmengx@126.com</email>
    </contact>
    <investigator>
      <last_name>Shaoliang Chen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Junjie Zhang, MD PHD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Chen SL, Sheiban I, Xu B, Jepson N, Paiboon C, Zhang JJ, Ye F, Sansoto T, Kwan TW, Lee M, Han YL, Lv SZ, Wen SY, Zhang Q, Wang HC, Jiang TM, Wang Y, Chen LL, Tian NL, Cao F, Qiu CG, Zhang YJ, Leon MB. Impact of the complexity of bifurcation lesions treated with drug-eluting stents: the DEFINITION study (Definitions and impact of complEx biFurcation lesIons on clinical outcomes after percutaNeous coronary IntervenTIOn using drug-eluting steNts). JACC Cardiovasc Interv. 2014 Nov;7(11):1266-76. doi: 10.1016/j.jcin.2014.04.026. Epub 2014 Oct 15.</citation>
    <PMID>25326748</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>May 14, 2023</last_update_submitted>
  <last_update_submitted_qc>May 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing First Hospital, Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Shaoliang Chen, MD</investigator_full_name>
    <investigator_title>Vice President</investigator_title>
  </responsible_party>
  <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/NCT03770650
org study id: NFH20180920
nct id: NCT03770650
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This study is designed to investigate whether IVUS-guided DK crush stenting technique
      compared to angiography-guided DK crush after the indexed procedure will lead to lower rates
      of the composite endpoint of target vessel failure (TVF) at 12 months. The individual
      components of TVF include cardiac death, target-vessel myocardial infarction (MI), or target
      vessel revascularization (TVR). Complex bifurcation lesions were defined according to
      DEFINITION study.
This is a prospective, multi-center, randomized-controlled, single blind, superiority trial
      that will include 35 international sites. The investigators aim to enroll 556 subjects with
      complex coronary bifurcation lesions in native coronary arterial segments.

      All patients with complex coronary bifurcation lesions suitable for DES implantation will
      undergo 1:1 randomization either to IVUS-guided or angiography-guided DK crush stenting using
      a randomization schedule blocked by site.

      All subjects will be screened according to the predefined inclusion and exclusion criteria
      per protocol and will further undergo angiography before DES implantation. Data and images
      will be collected during the index procedure, during re-intervention in the case of
      clinically driven TVF, and at the predefined 12-month clinical follow-up visit. All subjects
      will also undergo angiographic follow-up at 13 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will undergo 1:1 randomization to either IVUS-guided DKCrush stenting which will be the treatment group or Angio-guided DKCrush stenting which will be the control group based on an online Clinical Research Data Management Platform provided by King Yee,,Beijing CN. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1, 6, and 12 months after the index procedure. Angiographic follow-up is scheduled at 13 months.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcomes assessor will remain blinded until the final study results are released.
measure: Rate of target vessel failure
time frame: 12 months after DES implantation
description: TVF defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven TVR.
measure: Rate of stent thrombosis
time frame: 12 months after DES implantation
description: The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.
arm group label: IVUS-guided DK crush stenting
arm group type: Experimental
description: In the IVUS-guided DK crush stenting group, IVUS will be before side branch stenting, after rewiring side branch, after 1st kissing balloon inflation, after rewiring side branch, after 2nd kissing balloon inflation.
For LM bifurcation lesions involving ostial LAD and LCX: minimum stent are (MSA) should be ≥10mm2 (LM), 7 mm2 (LAD), and 6 mm2 (LCX), with stent expansion index ≥90% (CSA≥90% of distal reference lumen area in LCX) and symmetry index >0.8.
For non-LM bifurcation lesion involving the MSA should be ≥6 mm2 in the main vessel; and the MSA in the ostial side branch should be ≥5 mm2 and ≥90% of distal reference lumen area; and symmetry index should be >0.8.
arm group label: Angiography-guided DK crush stenting
arm group type: Active Comparator
description: In the Angiography-guided DK crush stenting group, stent diameter and length will be selected by visual estimation with a stent/artery ratio of 1.1:1.0. Post-dilation with a noncompliant balloon (balloon/stent diameter=1.0:1.0) inflated at >18 atm will be performed for all lesions. Angiographic success is defined as Thrombolysis In Myocardial Infarction (TIMI) grade 3, residual stenosis <20%, and the absence of ≥Type B dissection.
intervention type: Procedure
intervention name: Stenting
description: DK crush technique with SYNERGY (Boston Scientific) drug-eluting stent implantation.
arm group label: Angiography-guided DK crush stenting
arm group label: IVUS-guided DK crush stenting
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shao-Liang Chen, MD, PhD
role: Study Chair
affiliation: Nanjing First Hospital, Nanjing Medical University
last name: Shao-Liang Chen, MD, PhD
phone: +86-25-52208048
email: chmengx@126.com
last name: Jing Kan, MPH
phone: +86-25-52271398
email: kanjingok@126.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
citation: Chen SL, Sheiban I, Xu B, Jepson N, Paiboon C, Zhang JJ, Ye F, Sansoto T, Kwan TW, Lee M, Han YL, Lv SZ, Wen SY, Zhang Q, Wang HC, Jiang TM, Wang Y, Chen LL, Tian NL, Cao F, Qiu CG, Zhang YJ, Leon MB. Impact of the complexity of bifurcation lesions treated with drug-eluting stents: the DEFINITION study (Definitions and impact of complEx biFurcation lesIons on clinical outcomes after percutaNeous coronary IntervenTIOn using drug-eluting steNts). JACC Cardiovasc Interv. 2014 Nov;7(11):1266-76. doi: 10.1016/j.jcin.2014.04.026. Epub 2014 Oct 15.
PMID: 25326748
responsible party type: Principal Investigator
investigator affiliation: Nanjing First Hospital, Nanjing Medical University
investigator full name: Shaoliang Chen, MD
investigator title: Vice President
mesh term: Coronary Artery Disease
sharing ipd: No