Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
1 other identifier
observational
5,000
1 country
14
Brief Summary
The left distal radial approach (DRA) has been introduced as a feasible and safe alternative route of the radial artery. However, there is still lack of evidence for DRA regarding the feasibility, safety, effective time for hemostasis and hemostasis method. This prospective multicenter registry aimed to investigate the safety and efficacy of DRA for CAG and PCI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2019
CompletedFirst Posted
Study publicly available on registry
September 6, 2019
CompletedStudy Start
First participant enrolled
September 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2022
CompletedMay 11, 2022
May 1, 2022
2.1 years
August 31, 2019
May 10, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Success rate of coronary angiography
Success rate of coronary angiography (%)
Through procedure completion, up to 6 hours
Success rate of percutaneous coronary intervention
Success rate of percutaneous coronary intervention (%)
Through procedure completion, up to 6 hours
Secondary Outcomes (7)
Success rate of distal radial artery puncture
Through procedure completion, up to 6 hours
Puncture time
Through procedure completion, up to 6 hours
Hemostasis time
Through procedure completion, up to 24 hours
Puncture-related complications
Up to 1 month
Total procedure time
Through procedure completion, up to 6 hours
- +2 more secondary outcomes
Interventions
Operator puncture the distal radial artery with open needle or venipuncture catheter needle for coronary angiography and percutaneous coronary intervention.
Eligibility Criteria
Patients who need coronary angiography will be enrolled.
You may qualify if:
- Patients aged ≥ 20 years who planned coronary angiography
- Patients with palpable distal radial artery
- Patients who give informed consent
You may not qualify if:
- Patients with small or non-palpable distal radial artery
- Positive result in modified Allen test (suspicious of single blood supply)
- Pregnant women, possible candidate for pregnancy, or breastfeeding women
- Patients who are deemed unsuitable by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Yongin Severance Hospital
Yongin-si, Kyeonggi-do, 17046, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Kosin Univeristy Gospel Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
GangNeung Asan Hospital
Gangneung, South Korea
Inje University Ilsan Paik Hospital
Goyang, South Korea
Dongguk University Gyeongju Hospital
Gyeongju, South Korea
Uvis Hospital
Incheon, South Korea
The Catholic university of Korea Uijeongbu St. Mary's hospital
Uijeongbu-si, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Related Publications (3)
Roh JW, Heo SJ, Lee OH, Im E, Cho DK, Lee JW, Lee BK, Yoo SY, Lee SY, Kim CJ, Jin HY, Park JS, Heo JH, Kim DH, Lee JB, Kim DK, Bae JH, Lee SY, Lee SH, Kim Y. Distal Radial Access and Women: Implications for Access Site Outcomes in Coronary Procedures. J Am Heart Assoc. 2025 Apr 15;14(8):e036285. doi: 10.1161/JAHA.124.036285. Epub 2025 Apr 10.
PMID: 40207479DERIVEDJin IT, Roh JW, Lee OH, Im E, Cho DK, Lee JW, Lee BK, Yoo SY, Lee SY, Kim CJ, Jin HY, Park JS, Heo JH, Kim DH, Lee JB, Kim DK, Bae JH, Lee SY, Lee SH, Kim Y. Feasibility of Distal Radial Access in High Bleeding Risk Patients Who Underwent Percutaneous Coronary Intervention. Korean Circ J. 2025 Apr;55(4):291-301. doi: 10.4070/kcj.2024.0239. Epub 2024 Nov 14.
PMID: 39733460DERIVEDLee JW, Kim Y, Lee BK, Yoo SY, Lee SY, Kim CJ, Jin HY, Park JS, Heo JH, Kim DH, Lee JB, Kim DK, Bae JH, Lee SY, Lee SH. Distal Radial Access for Coronary Procedures in a Large Prospective Multicenter Registry: The KODRA Trial. JACC Cardiovasc Interv. 2024 Feb 12;17(3):329-340. doi: 10.1016/j.jcin.2023.11.021.
PMID: 38355261DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Hwan Lee, MD, PhD
Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 31, 2019
First Posted
September 6, 2019
Study Start
September 9, 2019
Primary Completion
October 30, 2021
Study Completion
January 23, 2022
Last Updated
May 11, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share