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Feasibility of percutaneous coronary intervention via left snuffbox approach in patients with coronary bifurcation lesions

Status Approved

  • First Submitted Date

    2021/03/30

  • Registered Date

    2021/04/08

  • Last Updated Date

    2021/04/08

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
    KCT0006072
    Unique Protocol ID CNUH-2021-046
    Public/Brief Title Feasibility of percutaneous coronary intervention via left snuffbox approach in patients with coronary bifurcation lesions
    Scientific Title Feasibility of percutaneous coronary intervention via left snuffbox approach in patients with coronary bifurcation lesions
    Acronym
    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 CNUH-2021-046
    Approval Date 2021-02-22
    Institutional Review Board Name Chonnam national university hospital institutional review board
    Institutional Review Board Address 42, Jebong-ro, Dong-gu, Gwangju
    Institutional Review Board Telephone 062-220-5257
    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 Myung Ho Jung
    Title Pf.
    Telephone +82-31-5189-8967
    Affiliation Chonnam National University Hospital
    Address 363 Dongbaekjukjeon-daero, Giheung-gu, Yongin-si, Gyeonggi-do, 16995, Republic of Korea
    Contact Person for Public Queries
    Name Oh-Hyun Lee
    Title Pf
    Telephone +82-31-5189-8786
    Affiliation Yonsei University Yongin Severance Hospital
    Address 363 Dongbaekjukjeon-daero, Giheung-gu, Yongin-si, Gyeonggi-do, 16995, Republic of Korea
    Contact Person for Updating Information
    Name Oh-Hyun Lee
    Title Pf.
    Telephone +82-31-5189-8786
    Affiliation Yonsei University Yongin Severance Hospital
    Address 363 Dongbaekjukjeon-daero, Giheung-gu, Yongin-si, Gyeonggi-do, 16995, Republic of 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 Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2021-03-02 Actual
    Target Number of Participant 106
    Primary Completion Date 2021-03-30 , Actual
    Study Completion Date 2022-03-01 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Chonnam National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2021-03-02 ,
  • 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 Chonnam National University Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University Yongin Severance Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Transradial approach (TRA) is widely accepted and recommended as the standard approach for coronary angiography and any percutaneous coronary intervention (PCI) irrespective of clinical presentation. Trans-radial cardiac catheterization has been reported to be more beneficial compared to femoral approaches with easier hemostasis, better patient comfort, earlier ambulation, shorter hospital stay and less occurrence of short-term cardiac death, myocardial infarction and access-site complications. However, the use of TRA is not free of limitations, as the radial artery is prone to spasm and often presents  anatomical variation including severe tortuosity or loop formation, which can lead to obligatory crossover to other arterial access. 
    Although previous studies have shown significantly lower rates of subclavian tortuosity and slightly shorter fluoroscopy times with left radial access compared to the right., left radial access is used less often, as it is not as ergonomic for the operator, especially for prolonged or complex PCI and in obese patients. Kiemeneji has recently proposed the radial artery cannulation in the anatomical snuffbox as an alternative radial artery cannulation. This new approach can overcome some drawbacks of standard radial artery approach in several aspects. Since the first publication in May 2017, several studies reported the safety and feasibility of the distal radial approach (DRA).
    Coronary bifurcation lesions are involved in 15-20% of all PCI and remain one of the most complex and challenging lesions in terms of procedural success rate as well as long-term cardiac event. (9) However, there is a paucity of data regarding the feasibility of the DRA for the bifurcation PCI. This study sought to investigate the efficacy and safety of the distal radial approach in PCI for bifurcation lesion.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-only
    Time Perspective Retrospective  
    Target Number of Participant 106
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Patients underwent bifurcation PCI via left distal radial artery

    Cohort/Group Description

    We performed a single center, retrospective cohort study of patients who underwent PCI for bifurcation lesions via left DRA. From the medical records of 1,041 consecutive patients with Snuffbox approach in Chonnam National University Hospital (Dec 2017 to Dec 2019), we identified 446 patients with successfully treated the coronary artery disease. Among them, we enrolled 106 patients who were treated with bifurcation PCI via left DRA
    
    We will evaluate the success rate of PCI, cross-over rate of the puncture site for pci, access-site complications including major bleeding requiring surgery or transfusion, hematoma, distal and forearm radial artery occlusion, and 30-day mortality.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    1,041 consecutive patients in the Snuffbox registry of Chonnam National University Hospital (Dec 2017 to Dec 2019)
    Sampling Method
    We performed a single center, retrospective cohort study of patients who underwent PCI for bifurcation lesions via left DRA.
    From the medical records of 1,041 consecutive patients in the Snuffbox database of Chonnam National University Hospital (Dec 2017 to Dec 2019), we identified 446 patients with successfully treated the coronary artery disease. Among them, we enrolled 106 patients who were treated with bifurcation PCI via left DRA.
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I25.1)Atherosclerotic heart disease 

    Coronary artery disease patients who underwent PCI for bifurcation lesions via left DRA
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    patients in the Snuffbox registry of Chonnam National University Hospital (Dec 2017 to Dec 2019)
    Exclusion Criteria
    no specific exclusion criteria
    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
    Success rate of percutaneous coronary intervention
    Timepoint
    just after procedure
    Secondary Outcome(s) 1
    Outcome
    Cross over rate of puncture site
    Timepoint
    just after procedure
    Secondary Outcome(s) 2
    Outcome
    30day mortality
    Timepoint
    one month after index procedure
    Secondary Outcome(s) 3
    Outcome
    radial artery occlusion
    Timepoint
    one month after index procedure
    Secondary Outcome(s) 4
    Outcome
    major bleeding requiring admission or surgery
    Timepoint
    one month after index procedure
    Secondary Outcome(s) 5
    Outcome
    access-site complication
    Timepoint
    one month after index procedure
  • 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 No
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