Comparison of Success Rate Between Distal Radial Approach and Radial Approach in STEMI

NCT ID: NCT03611725

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2023-12-13

Brief 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. 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.

Conditions

Distal Radial Artery Approach; ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Distal radial artery

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.

Group Type: ACTIVE_COMPARATOR

Distal radial artery

Intervention Type: PROCEDURE

The distal radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.

Radial artery

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.

Group Type: PLACEBO_COMPARATOR

Radial artery

Intervention Type: PROCEDURE

The radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.

Interventions

Distal radial artery

The distal radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.

Intervention Type: PROCEDURE

Radial artery

The radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 20 years
• ST-segment elevation myocardial infarction
• Palpable unilateral distal radial and radial artery

Exclusion Criteria

• 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
• Expected lifespan <12 months

• Eligible operator criteria
• Qualified operator who had experienced ≥ 100 cases of distal radial artery puncture

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical co., ltd.

OTHER

Sponsor Role: collaborator

Wonju Severance Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seung Hwan Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seung-Hwan Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

Locations

Kangwon National University College of Medicine

Chuncheon, Gangwon-do, South Korea

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

The Catholic university of Korea Uijeongbu St. Mary's hospital

Uijeongbu-si, Gyeonggi-do, South Korea

Countries

South Korea

References

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 Sep 29;4(11 Pt 1):102200. doi: 10.1016/j.jacadv.2025.102200. Online ahead of print.

Reference Type: DERIVED

PMID: 41027079 (View on PubMed)

Other Identifiers

DRAMI

Identifier Type: -

Identifier Source: org_study_id