Coronary Artery DiseaseNCT04080700
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
An observational study of Coronary Artery Disease and Radial Artery, run by Wonju Severance Christian Hospital at 14 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease, Radial Artery, Puncture
- What is being tested?
- Distal radial approach
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 9 Sep 2019to 23 Jan 2022
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who need coronary angiography will be enrolled.
Who may be able to join
- Patients aged ≥ 20 years who planned coronary angiography
- Patients with palpable distal radial artery
- Patients who give informed consent
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Inje University Busan Paik Hospital
Busan
Inje University Haeundae Paik Hospital
Busan
Kosin Univeristy Gospel Hospital
Busan
Pusan National University Hospital
Busan
Chungbuk National University Hospital
Cheongju-si
Kangwon National University Hospital
Chuncheon
Daegu Catholic University Medical Center
Daegu
GangNeung Asan Hospital
Gangneung
Inje University Ilsan Paik Hospital
Goyang
Dongguk University Gyeongju Hospital
Gyeongju
Uvis Hospital
Incheon
The Catholic university of Korea Uijeongbu St. Mary's hospital
Uijeongbu-si
Wonju Severance Christian Hospital
Wŏnju
Yongin Severance Hospital
Yongin-si, Kyeonggi-do, 17046
About this study
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.
Read the detailed description
Based on the results that radial approach (RA) reduced mortality and bleeding complications compared with femoral approach (FA), RA has become the standard of care for coronary angiography (CAG) and percutaneous coronary intervention (PCI). RA provides better comfortability for the patients and immediate mobilization after CAG or PCI. Therefore, 2018 ESC/EACTS guidelines recommend RA as the standard approach, unless there are overriding procedural considerations.
Operators usually prefer right RA because most of the operators are right-handed and right hand of the patient is closer to the operator. In contrast, longer distance to the left radial artery cause neck or back sprain of the operators, especially when the height of the operator is short, or the patient is obese. Nevertheless, left RA might be easier to manipulate catheter because of less tortuosity compared to the right RA and similar approach curvature with FA. Left RA also gives a chance to the right-handed patients to use their right hand freely.
Recently, the left distal radial approach (DRA) has been introduced as a feasible and safe alternative route of the radial artery. The left hand in the prone position is placed either on the left groin or beside the left hip according to operator preference. The operator punctures the distal radial artery around the anatomical snuffbox. After the first report for the feasibility and safety of left DRA in 70 patients, Lee et al. demonstrated that the success rates of arterial puncture, CAG and PCI were 95.5% (191/200), 100% (187/187), and 98.9% (86/87), respectively. The complication rates were only 7.9% including 14 (7.4%) minor hematomas and one (0.5%) arterial dissection. No serious complications were occurred such as distal radial artery occlusion, perforation, pseudoaneurysm, or arteriovenous fistula. Several studies for DRA also showed similar favorable results regarding procedural success and bleeding complications.
Radial arterial occlusion after RA remains an unsolved problem. According to the Leipzig prospective vascular ultrasound registry, the occlusion rate of radial artery was 14.4% in case of 5Fr sheath and 33.1% in 6Fr sheath, respectively. In this point of view, DRA could be a promising solution to lower the incidence rate of arterial occlusion. Moreover, DRA can have a potential benefit in patients requiring arteriovenous fistula and in patients who need the radial artery as a conduit for coronary artery bypass graft because of the absence of radial injury.
There is still lack of evidence for DRA regarding the feasibility, safety, effective time for hemostasis and hemostasis method. Unknown complications related to DRA also should be addressed. Therefore, this prospective multicenter registry aimed to investigate the safety and efficacy of DRA for CAG and PCI.
- Conditions
- Coronary Artery Disease, Radial Artery, Puncture
- Being tested
- Distal radial approach
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal radial approachProcedure or surgery
Operator puncture the distal radial artery with open needle or venipuncture catheter needle for coronary angiography and percutaneous coronary intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of coronary angiography
Success rate of coronary angiography (%)
Measured: Through procedure completion, up to 6 hours
Success rate of percutaneous coronary intervention
Success rate of percutaneous coronary intervention (%)
Measured: Through procedure completion, up to 6 hours
Secondary outcomes (7)
Success rate of distal radial artery puncture
Success rate of distal radial artery puncture (%)
Measured: Through procedure completion, up to 6 hours
Puncture time
Puncture time (minute)
Measured: Through procedure completion, up to 6 hours
Hemostasis time
Hemostasis time (minute)
Measured: Through procedure completion, up to 24 hours
Puncture-related complications
Puncture-related complications (%)
Measured: Up to 1 month
Total procedure time
Total procedure time (minutes)
Measured: Through procedure completion, up to 6 hours
Total fluoroscopic time
Total fluoroscopic time (minute)
Measured: Through procedure completion, up to 6 hours
Total fluoroscopic dose
Total fluoroscopic dose (Gray/cm2)
Measured: Through procedure completion, up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start9 Sep 2019
- Primary completion30 Oct 2021
- Study completion23 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Hwan Lee, Wonju Severance Christian Hospital
- Investigators
- Seung-Hwan Lee, MD, PhD, Principal investigator, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080700
- Sponsor's protocol ID
- KODRA
- Status last verified
- May 2022
- First submitted
- 31 Aug 2019
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jo J, Yoon WS, Jung M, Cho JH, Won KB, Cho EJ, Jeong YH, Kim SW, Lee JW, Kim Y, Lee BK, Yoo SY, Jin HY, Park JS, Heo JH, Kim DH, Lee JB, Kim DK, Bae JH, Lee SY, Lee SH, Kim SM, Lee SY; KODRA Investigators. Feasibility of Distal Radial Access in the Use of a Large-Bore Sheath for Percutaneous Coronary Intervention: Real-World Evidence From the Nationwide Cohort. Korean Circ J. 2026 Apr 28. doi: 10.4070/kcj.2025.0478. Online ahead of print.
PubMed 42204742Roh 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. Impact of obesity on palpation-guided distal radial access for coronary procedures: subgroup analysis of the multicenter, prospective KODRA registry. Cardiol J. 2025;32(6):598-606. doi: 10.5603/cj.106255. Epub 2025 Sep 4.
PubMed 40905084Roh 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.
PubMed 40207479Jin 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.
PubMed 39733460Lee 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.
PubMed 38355261
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
- ClinicalTrials.gov ID
- NCT04080700
- Acronym / sponsor ID
- KODRA
- Conditions
- Coronary Artery Disease, Radial Artery, Puncture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 23 Jan 2022 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Based on the results that radial approach (RA) reduced mortality and bleeding complications compared with femoral approach (FA), RA has become the standard of care for coronary angiography (CAG) and percutaneous coronary intervention (PCI). RA provides better comfortability for the patients and immediate mobilization after CAG or PCI. Therefore, 2018 ESC/EACTS guidelines recommend RA as the standard approach, unless there are overriding procedural considerations.
Operators usually prefer right RA because most of the operators are right-handed and right hand of the patient is closer to the operator. In contrast, longer distance to the left radial artery cause neck or back sprain of the operators, especially when the height of the operator is short, or the patient is obese. Nevertheless, left RA might be easier to manipulate catheter because of less tortuosity compared to the right RA and similar approach curvature with FA. Left RA also gives a chance to the right-handed patients to use their right hand freely.
Recently, the left distal radial approach (DRA) has been introduced as a feasible and safe alternative route of the radial artery. The left hand in the prone position is placed either on the left groin or beside the left hip according to operator preference. The operator punctures the distal radial artery around the anatomical snuffbox. After the first report for the feasibility and safety of left DRA in 70 patients, Lee et al. demonstrated that the success rates of arterial puncture, CAG and PCI were 95.5% (191/200), 100% (187/187), and 98.9% (86/87), respectively. The complication rates were only 7.9% including 14 (7.4%) minor hematomas and one (0.5%) arterial dissection. No serious complications were occurred such as distal radial artery occlusion, perforation, pseudoaneurysm, or arteriovenous fistula. Several studies for DRA also showed similar favorable results regarding procedural success and bleeding complications.
Radial arterial occlusion after RA remains an unsolved problem. According to the Leipzig prospective vascular ultrasound registry, the occlusion rate of radial artery was 14.4% in case of 5Fr sheath and 33.1% in 6Fr sheath, respectively. In this point of view, DRA could be a promising solution to lower the incidence rate of arterial occlusion. Moreover, DRA can have a potential benefit in patients requiring arteriovenous fistula and in patients who need the radial artery as a conduit for coronary artery bypass graft because of the absence of radial injury.
There is still lack of evidence for DRA regarding the feasibility, safety, effective time for hemostasis and hemostasis method. Unknown complications related to DRA also should be addressed. Therefore, this prospective multicenter registry aimed to investigate the safety and efficacy of DRA for CAG and PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who need coronary angiography will be enrolled.
Key inclusion criteria (3 listed)
- Patients aged ≥ 20 years who planned coronary angiography
- Patients with palpable distal radial artery
- Patients who give informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal radial approachOperator puncture the distal radial artery with open needle or venipuncture catheter needle for coronary angiography and percutaneous coronary intervention. | Procedure or surgery | – |
Primary outcome
Success rate of coronary angiography
Time frame: Through procedure completion, up to 6 hours
Success rate of coronary angiography (%)
Success rate of percutaneous coronary intervention
Time frame: Through procedure completion, up to 6 hours
Success rate of percutaneous coronary intervention (%)
7 secondary outcomes
Success rate of distal radial artery puncture
Time frame: Through procedure completion, up to 6 hours
Puncture time
Time frame: Through procedure completion, up to 6 hours
Hemostasis time
Time frame: Through procedure completion, up to 24 hours
Puncture-related complications
Time frame: Up to 1 month
Total procedure time
Time frame: Through procedure completion, up to 6 hours
Total fluoroscopic time
Time frame: Through procedure completion, up to 6 hours
Total fluoroscopic dose
Time frame: Through procedure completion, up to 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Derived from this study: PubMed 42204742Jo J, Yoon WS, Jung M, Cho JH, Won KB, Cho EJ, Jeong YH, Kim SW, Lee JW, Kim Y, Lee BK, Yoo SY, Jin HY, Park JS, Heo JH, Kim DH, Lee JB, Kim DK, Bae JH, Lee SY, Lee SH, Kim SM, Lee SY; KODRA Investigators. Feasibility of Distal Radial Access in the Use of a Large-Bore Sheath for Percutaneous Coronary Intervention: Real-World Evidence From the Nationwide Cohort. Korean Circ J. 2026 Apr 28. doi: 10.4070/kcj.2025.0478. Online ahead of print.
- Derived from this study: PubMed 40905084Roh 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. Impact of obesity on palpation-guided distal radial access for coronary procedures: subgroup analysis of the multicenter, prospective KODRA registry. Cardiol J. 2025;32(6):598-606. doi: 10.5603/cj.106255. Epub 2025 Sep 4.
- Derived from this study: PubMed 40207479Roh 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.
- Derived from this study: PubMed 39733460Jin 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.
- Derived from this study: PubMed 38355261Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Hwan Lee, MD, PhD principal investigator
Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Radial Artery, run by Wonju Severance Christian Hospital at 14 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of coronary angiography (time frame: Through procedure completion, up to 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04080700, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.