xml: <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/NCT06013007</url>
    </required_header>
    <id_info>
      <org_study_id>JINS</org_study_id>
      <nct_id>NCT06013007</nct_id>
    </id_info>
    <brief_title>Joint Inflation With Nominal-pressure and Stability Approach in DES Optimization</brief_title>
    <official_title>Joint Inflation With Nominal-pressure and Stability Approach in Coronary Drug-Eluting Stent Optimization and Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zunyi Medical College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zunyi Medical College</source>
    <oversight_info>
      <has_dmc>No</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>
        To achieve the stent optimization following &quot;Keep It Simple and Safe&quot; coronary intervention&#xD;
        is recommended. A protocol of Joint Inflation with Nominal-pressure and Stability (JINS)&#xD;
        approach in coronary drug-eluting stent (DES) implantation by intracoronary imaging (ICI)&#xD;
        guidance could provide additional benefits in reducing unnecessary radiation exposure, and&#xD;
        post-dilatation balloon angioplasty-related complications.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Variable types of stent inflation protocol to achieve evidence and consensus-based coronary&#xD;
        drug-eluting stent (DES) optimization could improve clinical outcomes. The investigators aim&#xD;
        to evaluate whether the JINS approach could be adopted in Chinese daily practice.&#xD;
  &#xD;
        The investigators will perform ICI (OCT or IVUS)-guided DES implantation in coronary de novo&#xD;
        lesions by JINS protocol, described as inflating stent balloon with nominal-pressure&#xD;
        (+1~2atm) without decay for at least 30 seconds.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 22, 2023</start_date>
    <completion_date type="Anticipated">September 22, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 22, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Eligible patients will be implanted with DES by Joint Inflation with Nominal-pressure and Stability (JINS) approach, which is described as inflating a stent balloon with nominal-pressure without decay for at least 30 seconds.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Stent optimization</measure>
      <time_frame>At 24 hours</time_frame>
      <description>To achieve the targets as follow: minimal stent area (MSA) &gt;5.5 mm2 by IVUS or MSA &gt;4.5mm2 by OCT, stent expansion &gt;80% (MSA divided by average reference lumen area), no significant malapposition, no significant stent edge dissection, no significant tissue protrusion, and successful DES implantation without the occurrence of cardiac death, target vessel myocardial infarction, target lesion revascularization, acute stent thrombosis during the first 24 hours after an index procedure.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Target vessel failure</measure>
      <time_frame>At 12 months</time_frame>
      <description>Composite of cardiac death, target vessel myocardial infarction, ischaemia-driven target vessel revascularization.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">130</enrollment>
    <condition>Acute Coronary Syndrome</condition>
    <condition>De Novo Stenosis</condition>
    <arm_group>
      <arm_group_label>JINS approach</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The JINS approach is described as inflating a stent balloon with nominal-pressure without decay for at least 30 seconds.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ICI-guided JINS approach</intervention_name>
      <description>OCT- or IVUS-guided JINS approach in DES implantation (DES types including Healing-Targeted SUPREME/Infinity Sirolimus-Eluting Stent, GuReater™ Sirolimus-Eluting Stent, XIENCE Alpine Everolimus-Eluting Stent, Promus PREMIER™ Everolimus-Eluting Stent, Resolute Integrity™ Zotarolimus-Eluting Stent, Firebird 2™ Sirolimus-Eluting Stent, Firekingfisher™ Sirolimus-Eluting Stent).</description>
      <arm_group_label>JINS approach</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with acute coronary syndrome (UA/NSTEMI/STEMI) plan to undergo OCT- or&#xD;
               IVUS-guided DES implantation in de novo lesion.&#xD;
  &#xD;
            -  Patients provide written informed consent prior to enrollment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Left main, ostial right coronary artery lesion.&#xD;
  &#xD;
            -  High thrombus burden at the index primary percutaneous coronary intervention.&#xD;
  &#xD;
            -  Active bleeding or bleeding diathesis, thrombocytopenia (platelet &lt;100,000/mL), or&#xD;
               hemoglobin &lt;10 g/dL&#xD;
  &#xD;
            -  Hepatic dysfunction (serum liver enzyme&gt;3 times the normal limit)&#xD;
  &#xD;
            -  Renal failure (eGFR &lt;15 ml/min/1.73m2 or requiring dialysis)&#xD;
  &#xD;
            -  Life expectancy &lt; 1 year&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cai De Jin, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Zunyi Medical College</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cai De Jin, MD</last_name>
      <phone>86+178-0250-2582</phone>
      <email>jincaide@zmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yan Yan Jin, MD</last_name>
      <phone>86+157-7229-0925</phone>
      <email>jinyanyan850925@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Affiliated Hospital of Zunyi Medical University</name>
        <address>
          <city>Zunyi</city>
          <state>Guizhou</state>
          <zip>563003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cai De Jin, MD</last_name>
        <phone>86+178-0250-2582</phone>
        <email>jincaide@zmu.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Yan Yan Jin, MD</last_name>
        <phone>86+157-7229-0925</phone>
        <email>jinyanyan850925@163.com</email>
      </contact_backup>
      <investigator>
        <last_name>Cai De Jin, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Hovasse T, Mylotte D, Garot P, Salvatella N, Morice MC, Chevalier B, Pichard A, Lefevre T. Duration of balloon inflation for optimal stent deployment: five seconds is not enough. Catheter Cardiovasc Interv. 2013 Feb;81(3):446-53. doi: 10.1002/ccd.23343. Epub 2012 Jan 10.</citation>
      <PMID>22109977</PMID>
    </results_reference>
    <results_reference>
      <citation>Ann SH, Chung JW, DE Jin C, Lee JH, Kim JM, Garg S, Shin ES. Better inflation time of stent balloon for second-generation drug-eluting stent expansion and apposition: an optical coherence tomography study. J Interv Cardiol. 2014 Apr;27(2):171-6. doi: 10.1111/joic.12096. Epub 2014 Mar 5.</citation>
      <PMID>24593834</PMID>
    </results_reference>
    <results_reference>
      <citation>Vallurupalli S, Kasula S, Kumar Agarwal S, Pothineni NVK, Abualsuod A, Hakeem A, Ahmed Z, Uretsky BF. A novel stent inflation protocol improves long-term outcomes compared with rapid inflation/deflation deployment method. Catheter Cardiovasc Interv. 2017 Aug 1;90(2):233-240. doi: 10.1002/ccd.26930. Epub 2017 Jan 23.</citation>
      <PMID>28112479</PMID>
    </results_reference>
    <results_reference>
      <citation>Raber L, Mintz GS, Koskinas KC, Johnson TW, Holm NR, Onuma Y, Radu MD, Joner M, Yu B, Jia H, Meneveau N, de la Torre Hernandez JM, Escaned J, Hill J, Prati F, Colombo A, di Mario C, Regar E, Capodanno D, Wijns W, Byrne RA, Guagliumi G; ESC Scientific Document Group. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018 Sep 14;39(35):3281-3300. doi: 10.1093/eurheartj/ehy285. Erratum In: Eur Heart J. 2019 Jan 14;40(3):308.</citation>
      <PMID>29790954</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zunyi Medical College</investigator_affiliation>
      <investigator_full_name>Cai De Jin, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>JINS; Intracoronary imaging; Stent optimization; Outcomes</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Coronary Syndrome</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013007
  org study id: JINS
  nct id: NCT06013007
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To achieve the stent optimization following "Keep It Simple and Safe" coronary intervention
        is recommended. A protocol of Joint Inflation with Nominal-pressure and Stability (JINS)
        approach in coronary drug-eluting stent (DES) implantation by intracoronary imaging (ICI)
        guidance could provide additional benefits in reducing unnecessary radiation exposure, and
        post-dilatation balloon angioplasty-related complications.
  Variable types of stent inflation protocol to achieve evidence and consensus-based coronary
        drug-eluting stent (DES) optimization could improve clinical outcomes. The investigators aim
        to evaluate whether the JINS approach could be adopted in Chinese daily practice.
  
        The investigators will perform ICI (OCT or IVUS)-guided DES implantation in coronary de novo
        lesions by JINS protocol, described as inflating stent balloon with nominal-pressure
        (+1~2atm) without decay for at least 30 seconds.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Eligible patients will be implanted with DES by Joint Inflation with Nominal-pressure and Stability (JINS) approach, which is described as inflating a stent balloon with nominal-pressure without decay for at least 30 seconds.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Stent optimization
  time frame: At 24 hours
  description: To achieve the targets as follow: minimal stent area (MSA) >5.5 mm2 by IVUS or MSA >4.5mm2 by OCT, stent expansion >80% (MSA divided by average reference lumen area), no significant malapposition, no significant stent edge dissection, no significant tissue protrusion, and successful DES implantation without the occurrence of cardiac death, target vessel myocardial infarction, target lesion revascularization, acute stent thrombosis during the first 24 hours after an index procedure.
  measure: Target vessel failure
  time frame: At 12 months
  description: Composite of cardiac death, target vessel myocardial infarction, ischaemia-driven target vessel revascularization.
  arm group label: JINS approach
  arm group type: Experimental
  description: The JINS approach is described as inflating a stent balloon with nominal-pressure without decay for at least 30 seconds.
  intervention type: Procedure
  intervention name: ICI-guided JINS approach
  description: OCT- or IVUS-guided JINS approach in DES implantation (DES types including Healing-Targeted SUPREME/Infinity Sirolimus-Eluting Stent, GuReater™ Sirolimus-Eluting Stent, XIENCE Alpine Everolimus-Eluting Stent, Promus PREMIER™ Everolimus-Eluting Stent, Resolute Integrity™ Zotarolimus-Eluting Stent, Firebird 2™ Sirolimus-Eluting Stent, Firekingfisher™ Sirolimus-Eluting Stent).
  arm group label: JINS approach
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Cai De Jin, MD
  role: Principal Investigator
  affiliation: Zunyi Medical College
  last name: Cai De Jin, MD
  phone: 86+178-0250-2582
  email: jincaide@zmu.edu.cn
  last name: Yan Yan Jin, MD
  phone: 86+157-7229-0925
  email: jinyanyan850925@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: China
  citation: Hovasse T, Mylotte D, Garot P, Salvatella N, Morice MC, Chevalier B, Pichard A, Lefevre T. Duration of balloon inflation for optimal stent deployment: five seconds is not enough. Catheter Cardiovasc Interv. 2013 Feb;81(3):446-53. doi: 10.1002/ccd.23343. Epub 2012 Jan 10.
  PMID: 22109977
  citation: Ann SH, Chung JW, DE Jin C, Lee JH, Kim JM, Garg S, Shin ES. Better inflation time of stent balloon for second-generation drug-eluting stent expansion and apposition: an optical coherence tomography study. J Interv Cardiol. 2014 Apr;27(2):171-6. doi: 10.1111/joic.12096. Epub 2014 Mar 5.
  PMID: 24593834
  citation: Vallurupalli S, Kasula S, Kumar Agarwal S, Pothineni NVK, Abualsuod A, Hakeem A, Ahmed Z, Uretsky BF. A novel stent inflation protocol improves long-term outcomes compared with rapid inflation/deflation deployment method. Catheter Cardiovasc Interv. 2017 Aug 1;90(2):233-240. doi: 10.1002/ccd.26930. Epub 2017 Jan 23.
  PMID: 28112479
  citation: Raber L, Mintz GS, Koskinas KC, Johnson TW, Holm NR, Onuma Y, Radu MD, Joner M, Yu B, Jia H, Meneveau N, de la Torre Hernandez JM, Escaned J, Hill J, Prati F, Colombo A, di Mario C, Regar E, Capodanno D, Wijns W, Byrne RA, Guagliumi G; ESC Scientific Document Group. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018 Sep 14;39(35):3281-3300. doi: 10.1093/eurheartj/ehy285. Erratum In: Eur Heart J. 2019 Jan 14;40(3):308.
  PMID: 29790954
  responsible party type: Principal Investigator
  investigator affiliation: Zunyi Medical College
  investigator full name: Cai De Jin, MD
  investigator title: Principal Investigator
  mesh term: Acute Coronary Syndrome