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Completed

NCT Number: NCT05461781

Distal Radial Access for Primary PCI in STEMI Patients to Prevent RAO

Randomized-controlled trial to compare early radial artery occlusion via distal vs. conventional transradial access among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Luhe hospital

Beijing, Beijing Municipality, 101149, China

About this study

Conventional transradial access (TRA) is recommended as the default approach for patients undergoing percutaneous coronary intervention (PCI) according to 2018 ESC guidelines. However, radial artery occlusion (RAO) remains the frequent complication, precluding the future use of the radial artery as an access point for repeat coronary recanalization or as a conduit for coronary artery bypass surgery. More than 50% of patients with ST segment elevation myocardial infarction (STEMI) present multiple vascular lesions, of which 50% require reprocessing non-culprit vessels. Therefore, the patency of the radial artery is crucial for STEMI patients. The distal radial access (DRA), located in the anatomical snuffbox or the dorsum of the hand, was introduced as a promising alternative. Three recent RCTs have shown significant reductions of RAO after DRA compared with TRA. Nevertheless, all of them excluded the patients presenting with STEMI. Therefore, we conduct a prospective, single-center, open-label randomized clinical trial to assess the superiority of preventing RAO at 24 h via DRA when compared TRA among STEMI patients for primary PCI.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • ST-segment elevation myocardial infarction for primary percuteous coronary intervention
  • Palpable pulses on both access sites of the radial artery
  • Informed consent

Exclusion criteria

  • Thrombolysis before primary percutaneous coronary intervention
  • Previous CABG or radio-cephalic fistula using radial artery
  • Cardiogenic shock
  • Severe arrhythmias
  • Severe liver and kidney dysfunction
  • Pregnancy
  • Enrolment in another study within 1 month
  • Inability to obtain written informed consent

Treatment and study plan

Distal radial access

Procedure

primary percutaneous coronary intervention via distal radial access

conventional transradial access

Procedure

primary percutaneous coronary intervention via conventional transradial access

Primary outcomes

  1. radial artery occlusion

    Time frame: at 24 hours after procedure

    The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound.

Secondary outcomes

  1. the rate of successful puncture

    Time frame: Immediately post-procedurally

    Successful puncture occurs when an introducer sheath can be properly placed through the punctured artery.

  2. puncture time

    Time frame: Immediately post-procedurally

    The puncture time was defined as the time interval between local anesthesia induction and successful sheath insertion.

  3. first medical contact to device (FMC2D) time

    Time frame: Immediately post-procedurally

    FMC2D time was defined as the time interval between the patient's initial contact with the first physician who made the diagnosis and the first angioplasty balloon inflation.

  4. procedural time

    Time frame: Immediately post-procedurally

    Procedural time defined as the time interval between local anesthesia to sheath removal.

  5. hemostasis time

    Time frame: at 24 hours after procedure

    Hemostasis time was defined as the time between sheath removal to complete hemostasis.

  6. access-related complications

    Time frame: at 24 hours after procedure

    Access-related complications include AV fistula formation, pseudoaneurysm, and local haematoma.

  7. hand function

    Time frame: 1 week after procedure

    Hand function was evaluated by QuickDASH questionnaire.

  8. radial artery occlusion

    Time frame: 30days after procedure

    The radial artery occlusion will be evaluated 1 month after procedure by ultrasound.

  9. radial aretry injury

    Time frame: Immediately post-procedurally

    Radial aretry injury including intimal tears, dissections, perforation and thrombosis was detected by optical coherence tomography.

  10. major adverse cardiovascular events(MACE)

    Time frame: 30 days after procedure

    MACE was defined as all-cause death, any myocardial infarction, stroke and major bleeding.

Sponsors and collaborators

Lead sponsor

Beijing Luhe Hospital

Other

Registry information

Official study title

Distal Radial Access for Primary Percutaneous Coronary Intervention in STEMI Patients to Prevent Acute Radial Artery Occlusion

Acronym: RAPIDIII

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2022
Registry last updated
Mar 11, 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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