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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2021/03/30
    • Registered Date : 2021/04/08
    • Last Updated Date : 2021/04/08
Background Information
1.Background  
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
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
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  
- Address 42, Jebong-ro, Dong-gu, Gwangju 
- Telephone 062-220-5257 
Data Monitoring Committee No  
Contact Details
3.Contact Details  
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 Health System, 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 Health System, Yongin Severance Hospital 
- Address 363 Dongbaekjukjeon-daero, Giheung-gu, Yongin-si, Gyeonggi-do, 16995, Republic of Korea 
Status
4. Status Status  
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 Site Chonnam National University Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2021-03-02 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Chonnam National University Hospital 
- Organization Type Medical Institute  
- Project ID  
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Yonsei University Health System, Yongin Severance Hospital 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
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.  
Study Design 정보
8. Study Design  
Study Type Observational Study 
Observational Study Model Case-only 
Time Perspective Retrospective  
Target Number of Participant 106
Cohort/Group Number
Cohort/
Group 1
Cohort/
Group Label
Patients underwent bifurcation PCI via left distal radial artery 
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  
Subject Eligibility Information
9. Subject  
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. <br />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) * Diseases of the circulatory system
Coronary artery disease patients who underwent PCI for bifurcation lesions via left DRA  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 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
Outcome Measure(s) Information
10. Outcome Measure(s)  
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 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No