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

August 16, 2025 updated by: Seung Hwan Lee, Wonju Severance Christian Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

352

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangwon-do
      • Chuncheon, Gangwon-do, Korea, Republic of
        • Kangwon National University College of Medicine
      • Wonju, Gangwon-do, Korea, Republic of, 26426
        • Wonju Severance Christian Hospital
    • Gyeonggi-do
      • Uijeongbu, Gyeonggi-do, Korea, Republic of
        • The Catholic University of Korea Uijeongbu St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Distal radial artery
The distal radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.
Placebo Comparator: 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.
Procedure: Radial artery
The radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through procedure completion, up to 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of coronary angiography (%)
Time Frame: Through procedure completion, up to 6 hours
The success rate (%) of coronary angiography will be compared between distal radial artery approach and radial artery approach group.
Through procedure completion, up to 6 hours
Success rate of percutaneous coronary intervention (%)
Time Frame: Through procedure completion, up to 6 hours
The success rate (%) of percutaneous coronary intervention will be compared between distal radial artery approach and radial artery approach group.
Through procedure completion, up to 6 hours
Procedure success rate (%)
Time Frame: Through procedure completion, up to 6 hours
The success rate (%) of final procedure will be compared between distal radial artery approach and radial artery approach group.
Through procedure completion, up to 6 hours
Bleeding complication rate (%)
Time Frame: During hospitalization, up to 1 month
The bleeding complication rate (%) will be compared between distal radial artery approach and radial artery approach group.
During hospitalization, up to 1 month
Total procedure time (minutes)
Time Frame: Through procedure completion, up to 6 hours
Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups.
Through procedure completion, up to 6 hours
Total fluoroscopic time (minute)
Time Frame: Through procedure completion, up to 6 hours
Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups.
Through procedure completion, up to 6 hours
Total fluoroscopic dose (Gray/cm2)
Time Frame: Through procedure completion, up to 6 hours
Scale range: 0 - 500 Gray/cm2 Lesser fluoroscopic dose is better. An averaged value will be compared and reported between two groups.
Through procedure completion, up to 6 hours
Puncture time (minute)
Time Frame: Through procedure completion, up to 6 hours
Scale range: 0 - 60 minutes Shorter time is considered better result. An averaged time value will be compared and reported between two groups.
Through procedure completion, up to 6 hours
MACE (%)
Time Frame: 1 month
Incidence rate (%) of composite endpoints defined as all-cause death, any myocardial infarction, and any revascularization
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wonju Severance Christian Hospital

Collaborators

Hanmi Pharmaceutical co., ltd.

Investigators

  • Principal Investigator: Seung-Hwan Lee, MD, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2018

Primary Completion (Actual)

March 7, 2023

Study Completion (Actual)

December 13, 2023

Study Registration Dates

First Submitted

July 17, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 16, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRAMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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