Distal Radial Artery ApproachNCT03611725
Comparison of Success Rate Between Distal Radial Approach and Radial Approach in STEMI
A study testing Distal radial artery and Radial artery in people with Distal Radial Artery Approach and ST Elevation Myocardial Infarction, run by Wonju Severance Christian Hospital at 3 sites in South Korea.
Trial summary
ST-segment elevation myocardial infarction (STEMI) is an emergent disease to treat as soon as possible. 2017 ESC guidelines for the management of STEMI recommend using radial approach (RA) rather than femoral approach (FA) to reduce mortality and bleeding complications if the operators are expert for RA. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Distal Radial Artery Approach, ST Elevation Myocardial Infarction
- What is being tested?
- Distal radial artery and Radial artery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 15 Aug 2018to 13 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 20 years
- ST-segment elevation myocardial infarction
- Palpable unilateral distal radial and radial artery
Who cannot join
- Cardiogenic shock
- Thrombolysis before primary percutaneous coronary intervention
- Inability to obtain written informed consent
- Patient with ipsilateral arteriovenous fistula
- Participation in another ongoing clinical trial
- Pregnancy
Show all 9Show fewer
- Expected lifespan <12 months
- Eligible operator criteria
- Qualified operator who had experienced ≥ 100 cases of distal radial artery puncture
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Kangwon National University College of Medicine
Chuncheon, Gangwon-do
The Catholic university of Korea Uijeongbu St. Mary's hospital
Uijeongbu-si, Gyeonggi-do
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
About this study
Official title: Comparison of Success Rate Between Distal Radial Approach and Radial Approach in ST-segment Elevation Myocardial Infarction
ST-segment elevation myocardial infarction (STEMI) is an emergent disease to treat as soon as possible. 2017 ESC guidelines for the management of STEMI recommend using radial approach (RA) rather than femoral approach (FA) to reduce mortality and bleeding complications if the operators are expert for RA. Recently, Ferdinand Kiemeneij reported that distal radial approach (DRA) could be a feasible and safe route for coronary angiography (CAG) and percutaneous coronary intervention (PCI) in 70 patients. The right-handed patient could feel more comfortable in left DRA than right RA. Left DRA also could provide a better comfortable position for the operator compared to left RA. Distal radial artery is located around the anatomical snuffbox, which doesn't contain nerve and vein beside artery. Therefore, the possibility of procedure-related complications such as nerve injury or arteriovenous fistula is very low. Also, the superficial location of DRA could make easier hemostasis. There were no vascular-related complications from the report of Kiemeneij. But, the rate of puncture failure was 11%, which was higher than RA-based study (5.34% in STEMI patients of RIVAL trial, 6% in RIFLESTEACS trial and 5.8% in MATRIX trial). Nevertheless, this study was a pilot study with a small number of patients. There is no clinical study to compare the feasibility and safety for CAG and PCI between DRA and RA in patients with STEMI. Therefore, this study aimed to evaluate whether DRA is feasible and safe compared to RA in STEMI setting.
- Being tested
- Distal radial artery, Radial artery
- Keywords
- Distal radial approach, ST Elevation Myocardial Infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal radial arteryProcedure or surgery
The distal radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.
Radial arteryProcedure or surgery
The radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Distal radial artery | Active comparator | After subcutaneous injection of lidocaine, the distal radial artery around the bony surface area is punctured with a 20-gauge venipuncture catheter needle or steel needle according to the operator's discretion. After successful puncture, flexible, straight plastic 0.025" mini-guidewire is inserted through the hole of the puncture needle. Then, Radifocus® introducer sheath (Terumo, Tokyo, Japan) is inserted into the distal radial artery. Receives: Procedure: Distal radial artery |
| Radial artery | Placebo comparator | After subcutaneous injection of lidocaine, the radial artery is punctured with a 20-gauge venipuncture catheter needle or steel needle according to the operator's discretion. After successful puncture, flexible, straight plastic 0.025" mini-guidewire is inserted through the hole of the puncture needle. Then, Radifocus® introducer sheath (Terumo, Tokyo, Japan) is inserted into the radial artery. Receives: Procedure: Radial artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puncture success rate (%)
The success rate (%) of arterial puncture will be compared between distal radial artery approach and radial artery approach group.
Measured: Through procedure completion, up to 6 hours
Secondary outcomes (9)
Success rate of coronary angiography (%)
The success rate (%) of coronary angiography will be compared between distal radial artery approach and radial artery approach group.
Measured: Through procedure completion, up to 6 hours
Success rate of percutaneous coronary intervention (%)
The success rate (%) of percutaneous coronary intervention will be compared between distal radial artery approach and radial artery approach group.
Measured: Through procedure completion, up to 6 hours
Procedure success rate (%)
The success rate (%) of final procedure will be compared between distal radial artery approach and radial artery approach group.
Measured: Through procedure completion, up to 6 hours
Bleeding complication rate (%)
The bleeding complication rate (%) will be compared between distal radial artery approach and radial artery approach group.
Measured: During hospitalization, up to 1 month
Total procedure time (minutes)
Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups.
Measured: Through procedure completion, up to 6 hours
Total fluoroscopic time (minute)
Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups.
Measured: Through procedure completion, up to 6 hours
Total fluoroscopic dose (Gray/cm2)
Scale range: 0 - 500 Gray/cm2 Lesser fluoroscopic dose is better. An averaged value will be compared and reported between two groups.
Measured: Through procedure completion, up to 6 hours
MACE (%)
Incidence rate (%) of composite endpoints defined as all-cause death, any myocardial infarction, and any revascularization
Measured: 1 month
Puncture time (minute)
Scale range: 0 - 60 minutes Shorter time is considered better result. An averaged time value will be compared and reported between two groups.
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 posted2 Aug 2018
- Study start15 Aug 2018
- Primary completion7 Mar 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radial Artery ApproachStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized either distal radial approach or radial approach.
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanmi Pharmaceutical co., ltd.
- Responsible party
- Principal investigator, Seung Hwan Lee, Wonju Severance Christian Hospital
- Investigators
- Seung-Hwan Lee, MD, Principal investigator, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611725
- Sponsor's protocol ID
- DRAMI
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2018
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JW, Kim CJ, Lee BK, Ahn SG, Youn YJ, Lee JH, Jeon HS, Kim SY, Jang J, Bu S, Ahn HS, Lim S, Yim HW, Lee SH. Distal Radial Access vs Transradial Access in Patients With ST-Segment Elevation Myocardial Infarction: The DRAMI Trial. JACC Adv. 2025 Nov;4(11 Pt 1):102200. doi: 10.1016/j.jacadv.2025.102200. Epub 2025 Sep 29.
PubMed 41027079
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Success Rate Between Distal Radial Approach and Radial Approach in ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03611725
- Acronym / sponsor ID
- DRAMI
- Keywords
- Distal radial approach, ST Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Collaborators
- Hanmi Pharmaceutical co., ltd.
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 2 Aug 2018 (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.
ST-segment elevation myocardial infarction (STEMI) is an emergent disease to treat as soon as possible. 2017 ESC guidelines for the management of STEMI recommend using radial approach (RA) rather than femoral approach (FA) to reduce mortality and bleeding complications if the operators are expert for RA. Recently, Ferdinand Kiemeneij reported that distal radial approach (DRA) could be a feasible and safe route for coronary angiography (CAG) and percutaneous coronary intervention (PCI) in 70 patients. The right-handed patient could feel more comfortable in left DRA than right RA. Left DRA also could provide a better comfortable position for the operator compared to left RA. Distal radial artery is located around the anatomical snuffbox, which doesn't contain nerve and vein beside artery. Therefore, the possibility of procedure-related complications such as nerve injury or arteriovenous fistula is very low. Also, the superficial location of DRA could make easier hemostasis. There were no vascular-related complications from the report of Kiemeneij. But, the rate of puncture failure was 11%, which was higher than RA-based study (5.34% in STEMI patients of RIVAL trial, 6% in RIFLESTEACS trial and 5.8% in MATRIX trial). Nevertheless, this study was a pilot study with a small number of patients. There is no clinical study to compare the feasibility and safety for CAG and PCI between DRA and RA in patients with STEMI. Therefore, this study aimed to evaluate whether DRA is feasible and safe compared to RA in STEMI setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized either distal radial approach or radial approach.
| Arm | Type | Receives |
|---|---|---|
| Distal radial artery | Active comparator | Procedure: Distal radial arteryAfter subcutaneous injection of lidocaine, the distal radial artery around the bony surface area is punctured with a 20-gauge venipuncture catheter needle or steel needle according to the operator's discretion. After successful puncture, flexible, straight plastic 0.025" mini-guidewire is inserted through the hole of the puncture needle. Then, Radifocus® introducer sheath (Terumo, Tokyo, Japan) is inserted into the distal radial artery. |
| Radial artery | Placebo comparator | Procedure: Radial arteryAfter subcutaneous injection of lidocaine, the radial artery is punctured with a 20-gauge venipuncture catheter needle or steel needle according to the operator's discretion. After successful puncture, flexible, straight plastic 0.025" mini-guidewire is inserted through the hole of the puncture needle. Then, Radifocus® introducer sheath (Terumo, Tokyo, Japan) is inserted into the radial artery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 20 years
- ST-segment elevation myocardial infarction
- Palpable unilateral distal radial and radial artery
Key exclusion criteria (9 listed)
- Cardiogenic shock
- Thrombolysis before primary percutaneous coronary intervention
- Inability to obtain written informed consent
- Patient with ipsilateral arteriovenous fistula
- Participation in another ongoing clinical trial
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 arteryThe distal radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed. | Procedure or surgery | Distal radial artery |
| Radial arteryThe radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed. | Procedure or surgery | Radial artery |
Primary outcome
Puncture success rate (%)
Time frame: Through procedure completion, up to 6 hours
The success rate (%) of arterial puncture will be compared between distal radial artery approach and radial artery approach group.
9 secondary outcomes
Success rate of coronary angiography (%)
Time frame: Through procedure completion, up to 6 hours
Success rate of percutaneous coronary intervention (%)
Time frame: Through procedure completion, up to 6 hours
Procedure success rate (%)
Time frame: Through procedure completion, up to 6 hours
Bleeding complication rate (%)
Time frame: During hospitalization, up to 1 month
Total procedure time (minutes)
Time frame: Through procedure completion, up to 6 hours
Total fluoroscopic time (minute)
Time frame: Through procedure completion, up to 6 hours
Total fluoroscopic dose (Gray/cm2)
Time frame: Through procedure completion, up to 6 hours
MACE (%)
Time frame: 1 month
Puncture time (minute)
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 22 Aug 2025.
- Derived from this study: PubMed 41027079Lee JW, Kim CJ, Lee BK, Ahn SG, Youn YJ, Lee JH, Jeon HS, Kim SY, Jang J, Bu S, Ahn HS, Lim S, Yim HW, Lee SH. Distal Radial Access vs Transradial Access in Patients With ST-Segment Elevation Myocardial Infarction: The DRAMI Trial. JACC Adv. 2025 Nov;4(11 Pt 1):102200. doi: 10.1016/j.jacadv.2025.102200. Epub 2025 Sep 29.
- Individual participant dataSharing planned: No
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 principal investigator
Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal radial artery and Radial artery in people with Distal Radial Artery Approach and ST Elevation Myocardial Infarction, run by Wonju Severance Christian Hospital at 3 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 9 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 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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?
Puncture success rate (%) (time frame: Through procedure completion, up to 6 hours). 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 NCT03611725, which also lists 1 linked publication.
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 22 Aug 2025.