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OpenTrials
Completed

NCT Number: NCT05605288

Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI

Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed for undertaking percutaneous coronary angiography and interventions. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium

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About this study

Gaining vascular access is the first, mandatory step for undertaking percutaneous coronary angiography and interventions. The recent guidelines, published by European Society of Cardiology (ESC), American College of Cardiology (ACC), American Heart Association (AHA) and Society for Cardiovascular Angiography and Interventions (SCAI), propose TRA as the gold standard for acute coronary syndromes (ACS), chronic coronary syndrome (CCS) percutaneous coronary interventions (PCI). Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Mutual point of all the previous RCTs is that excluded patients suffering from ST-elevation Myocardial Infraction (STEMI). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years old
  • Indication: ST-Elevation Myocardial Infraction

Exclusion criteria

  • Non-palpable radial artery
  • Previous CABG
  • Anatomical restrictions for forearm approach
  • Hemodynamic instability
  • Previous radial artery catheterization from the same arm during the last 30-days

Treatment and study plan

Coronary angiography +/- percutaneous coronary intervention

Procedure

Coronary angiography +/- percutaneous coronary intervention

Primary outcomes

  1. needle-to-wire time

    Time frame: Immediately post-procedurally

    needle-to-wire time

Secondary outcomes

  1. Radial artery occlusion using Doppler examination prior to hospital discharge

    Time frame: The evaluation will be performed during hospitalization for STEMI and prior discharge, typically the 4th day after PCI

    Radial artery patency evaluation with Doppler ultrasound prior to hospital discharge for detecting possible occlusion after cannulation

  2. Access site crossover rate

    Time frame: Immediately post-procedurally

    Crossover rate from distal transradial artery access to other access point

  3. Sheath insertion time

    Time frame: Immediately post-procedurally

    Duration required from the beginning of puncture until sheath insertion

  4. Total procedure time

    Time frame: Immediately post-procedurally

    Total duration of coronary angiography and angioplasty

  5. The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI

    Time frame: Immediately post-procedurally

    The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI

  6. Required time for coronary angiography completion, after sheath insertion

    Time frame: Immediately post-procedurally

    Required time for coronary angiography completion, after sheath insertion

  7. Required time percutaneous coronary intervention completion

    Time frame: Immediately post-procedurally

    Required time percutaneous coronary intervention completion

  8. Total fluoroscopy time

    Time frame: Immediately post-procedurally

    Total fluoroscopy time

  9. Total Dose Area Product (DAP)

    Time frame: Immediately post-procedurally

    Total Dose Area Product (DAP)

  10. Air Kerma

    Time frame: Immediately post-procedurally

    Air Kerma

  11. Hemostasis time

    Time frame: 3 hours

    Time required for achieving hemostasis

  12. Vascular complications

    Time frame: 24 hours

    Vascular complications

  13. Hematomas classification (modified EASY classification)

    Time frame: 24 hours

    Hematomas classification using modified EASY which is compatible with dTRA

  14. 30-days Clinical follow-up (on site or via telephone call)

    Time frame: 30 days

    30-days Clinical follow-up (on site or via telephone call)

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Official study title

Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With ST-elevation Myocardial Infraction (STEMI): The DR-STEMI Trial

Acronym: DR-STEMI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2022
Registry last updated
Jul 6, 2026

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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