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Comparison of Clinical outcomes between angio-guided spot stenting and angio-guided entire stenting using Zotarolimus eluting stent with the patients with diffuse long coronary lesions.

Status Approved

  • First Submitted Date

    2017/12/13

  • Registered Date

    2018/08/13

  • Last Updated Date

    2018/07/18

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003082
    Unique Protocol ID MD16034
    Public/Brief Title Comparison of Clinical outcomes between angio-guided spot stenting and angio-guided entire stenting using Zotarolimus eluting stent with the patients with diffuse long coronary lesions.
    Scientific Title Comparison of Clinical outcomes between angio-guided spot stenting and angio-guided entire stenting using Zotarolimus eluting stent with the patients with diffuse long coronary lesions.
    Acronym SPOT trial
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number MD16034-002
    Approval Date 2016-08-10
    Institutional Review Board Name Korea University Guro hospital Institutional Review Board
    Institutional Review Board Address IRB Office, 4th Floor, Life Research Center, Korea University Guro Hospital, 148, Guro-dong, Guro-gu, Seoul, Korea
    Institutional Review Board Telephone 02-2626-1858
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Seung Woon Rha
    Title Professor
    Telephone +82-2-2626-3020
    Affiliation Koera University Guro Hospital
    Address Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea
    Contact Person for Public Queries
    Name Seung Woon Rha
    Title Professor
    Telephone +82-2-2626-3020
    Affiliation Koera University Guro Hospital
    Address Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea
    Contact Person for Updating Information
    Name Seung Woon Rha
    Title Professor
    Telephone +82-2-2626-3020
    Affiliation Koera University Guro Hospital
    Address Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 9
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2016-09-30 Actual
    Target Number of Participant 470
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Cheongju ST.Mary's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2016-11-23 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Hallym University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2017-03-02 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Soon Chun Hyang University Hospital Cheonan
    Recruitment Status Recruiting
    Date of First Enrollment 2017-03-14 ,
    Recruitment Status by Participating Study Site 4
    Name of Study The Catholic University of Korea, St. Paul's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2017-09-15 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Chonnam National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2016-12-20 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Eulji University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2016-09-30 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Seoul National University Bundang Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2017-10-23 ,
    Recruitment Status by Participating Study Site 8
    Name of Study Kangwon National University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-10-01 ,
    Recruitment Status by Participating Study Site 9
    Name of Study Koera University Guro Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2016-10-25 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Medtronic Korea
    Organization Type Pharmaceutical Company
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Koera University Guro Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    1. Purpose of Study
        The purpose of this study was to evaluate the efficacy and safety of intracoronary stent implantation for the treatment of diffuse long-term lesions, based on angiographic findings, with stent insertion centered on the most severe stenosis, We aimed to compare the clinical results up to 1 year among patients undergoing extensive stenting without residual lesions by performing a total stenting in the area.
    
    
    
    
    
    2. Research Background
      Stent length was known to be a cause of strong stent restenosis in the past, but the effect of stent length on stent restenosis after the emergence of drug-eluting stent was greatly reduced. , It is recommended that large stents be inserted where there is no atherosclerosis as much as possible in fear of stent length during drug-releasing stent implantation. An intravenous ultrasound intervention should be considered as an ideal stent insertion site of less than 40% plaque burden Is recommended.
    However, it has been reported that a long stent implantation of 31.5 mm or longer may increase the risk of stent thrombosis in a diffuse long lesion, which leads to an excessively long stent length. In the case of a diffuse lesion with a stent length of 80 ± 20 mm, a 6-month restenosis rate of more than 19% was reported.In addition, the use of an overstaged stent implantation for long- And 23% of infarcts, suggesting concern about the safety of long stenting in long lesions.
    In addition, the results of the second- or third-generation DES recently introduced due to the rapid development of DES are less known. In contrast, stent implantation with a partial bovine stent placement, which would leave a residual lesion on both ends of the stent, is associated with restenosis or intra-segmental restenosis. The larger diameter of the network compared to the distal and proximal portions of the stent, Is known to be a predictor of endosteal stenosis. In addition, stent thrombosis is the most common cause of stent thrombosis.
    According to Demosthenes G, 2009, preliminary studies have shown that the use of a first-generation stent for lower-stent restenosis and angina pectoris recurrence is more advantageous than for long-stenting stent implantation, but a clearer result is required. Therefore, in the actual clinical practice, the choice of the two procedures is difficu- larly selected by the practitioner according to the individual clinical situation in the diffuse long lesion.
    
    3. Research hypothesis
       In a similar study of the study, Am J Cardiol 2009; 104: 786-790 by DEMOSTHENES G. KATRITSIS reported that the spot stenting group compared to the entire stenting group There is no significant difference in 1-year target vessel failure rate. The overall hypothesis was that when the 1-year target vessel failure rate was 7% in the control group, the entire stenting group, the allergic hypothesis was "one-year target vessel failure rate in the spot stenting group, The difference in the 1-year target vessel failure rate of stenting will be within 6% of the non-inferiority margin. "
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase4
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Medical Device  
    Intervention Description
    In angio-guided angio-guided stent implantation with diffuse long lesion, stent placement with the stenosis centered on the most severe stenosis was performed and spot stenting was performed, leaving a residual lesion in the proximal or distal portion of the stent. And to compare the clinical results between the patients who underwent extensive stenting and the patients who underwent total stenting without residual lesion.
    Number of Arms 2
    Arm 1

    Arm Label

    Spot Stenting group

    Target Number of Participant

    235

    Arm Type

    Experimental

    Arm Description

    Stent insertion with angio-guided angiography in the diffuse long lesion with stent insertion centered on the most severe stenosis in the proximal or distal portion of the stent
    Arm 2

    Arm Label

    Entire stenting group

    Target Number of Participant

    235

    Arm Type

    Active comparator

    Arm Description

    In angio-guided angio-guided diffuse long lesions, extensive stenting was performed in the entire area of ​​the lesion centered on the most severe stenosis, resulting in complete stenting without residual lesion.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I20.88)Other forms of angina pectoris 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    1. Age Only patients with stable angina or unstable angina over 19 years
    2. Reference diameter ≥ 2.5 mm lesion length ≥ 25 mm
    3. De novo lesions with% Diameter stenosis ≥50%
    4. Patient with Core lesion for spot stenting
    For definitions of core lesions, see Clinical Trial Methods.
    Exclusion Criteria
    1. Ascitic (aspirin), clopidogrel (Clopidogrel) and anti-platelet agents, such as those who are contraindicated
    2. Left-sided lesions (left main lesion, internal diameter stenosis (diameter stenosis) ≥50%)
    3. A recent hematologic disease or white blood cell count of 3000 / mm3 and / or platelet count of 100,000 / mm3. Who show less
    4. Severe epicardial disease with a longevity of less than 1 year
    5. Those who plan to perform two stenting operations on branch vessels and branch lesions with basilar lesions
    6. Patients who underwent emergency stenting after a diagnosis of myocardial infarction within 24 hours (STEMI, NSTEMI can be enrolled after 24 hours)
    7. Who can not comply with the research plan
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    cardiac death
    Timepoint
    target vessel failure for 12 months
    Primary Outcome(s) 2
    Outcome
    Target vessel myocardial infarction
    Timepoint
    target vessel failure for 12 months
    Primary Outcome(s) 3
    Outcome
    STEMI and NSTEMI- Including periprocedural myocardial infarction
    Timepoint
    target vessel failure for 12 months
    Primary Outcome(s) 4
    Outcome
    Ischemic driven target vessel revascularization
    Timepoint
    target vessel failure for 12 months
    Secondary Outcome(s) 1
    Outcome
    All death
    Timepoint
    for 12 months
    Secondary Outcome(s) 2
    Outcome
    STEMI and NSTEMI-periprocedural MI
    Timepoint
    for 12 months
    Secondary Outcome(s) 3
    Outcome
    Target lesion revascularization (TLR)
    Timepoint
    for 12 months
    Secondary Outcome(s) 4
    Outcome
    target vessel revascularization (Non-TVR),
    Timepoint
    for 12 months
    Secondary Outcome(s) 5
    Outcome
    Stent thrombosis
    Timepoint
    for 12 months
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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