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  • Status : Approved
    • First Submitted Date : 2021/03/30
    • Registered Date : 2021/04/08
    • Last Updated Date : 2021/04/08
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1. Background

Background Information
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 
Address 42, Jebong-ro, Dong-gu, Gwangju 
Telephone 062-220-5257 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
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 

4. Status

Status Information
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

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Chonnam National University Hospital 
Organization Type Medical Institute  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Yonsei University Health System, 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 
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 
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. <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
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

10. Outcome Measure(s)

Outcome Measure(s) Information
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 No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement No 
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