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

NCT03611725 | Completed

• 1 other identifier: DRAMI
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 3

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

Keywords

Distal radial approach; ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Puncture success rate (%)

  The success rate (%) of arterial puncture will be compared between distal radial artery approach and radial artery approach group.

  Through procedure completion, up to 6 hours

Secondary Outcomes (9)

• Success rate of coronary angiography (%)

  Through procedure completion, up to 6 hours

• Success rate of percutaneous coronary intervention (%)

  Through procedure completion, up to 6 hours

• Procedure success rate (%)

  Through procedure completion, up to 6 hours

• Bleeding complication rate (%)

  During hospitalization, up to 1 month

• Total procedure time (minutes)

  Through procedure completion, up to 6 hours

Study Arms (2)

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.

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.

Procedure: Radial artery

Interventions

Distal radial artery PROCEDURE

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

Distal radial artery

Radial artery PROCEDURE

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

Radial artery

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead
• Hanmi Pharmaceutical co., ltd.: collaborator

Study Sites (3)

Kangwon National University College of Medicine

Chuncheon, Gangwon-do, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

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

Uijeongbu-si, Gyeonggi-do, South Korea

Location

Related Publications (1)

• 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.

  PMID: 41027079 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Seung-Hwan Lee, MD

  Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomized either distal radial approach or radial approach.

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 2, 2018
• Study Start: August 15, 2018
• Primary Completion: March 7, 2023
• Study Completion: December 13, 2023
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)