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Completed

NCT Number: NCT03611725

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangwon National University College of Medicine, Chuncheon, Gangwon-do, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

radial artery

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. MACE (%)

    Time frame: 1 month

    Incidence rate (%) of composite endpoints defined as all-cause death, any myocardial infarction, and any revascularization

  9. 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.

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Collaborators

  • Hanmi Pharmaceutical co., ltd.

Registry information

Official study title

Comparison of Success Rate Between Distal Radial Approach and Radial Approach in ST-segment Elevation Myocardial Infarction

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2018
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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