Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI

Last updated: November 12, 2023
Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Cardiovascular Disease

Heart Defect

Treatment

percutaneous coronary intervention (PCI)

Radial Artery approach on percutaneous coronary intervention (PCI)

Clinical Study ID

NCT06013813
23-1367
  • Ages > 18
  • All Genders

Study Summary

This clinical trial aims to compare conventional radial access versus distal radial access in patients with STEMI undergoing PCI. The main question it aims to answer is:

• Mayor adverse cardiac events (MACE) at 30 days in STEMI patients treated by PCI are not inferior when comparing the distal radial approach versus the conventional radial approach ?

Participants will:

  • sign the informed consent to enroll in the clinical trial.

  • will agree to be treated by PCI

  • will be randomized 1:1 to perform PCI by conventional radial or distal radial approach.

If there is a comparison group:

Researchers will compare conventional radial access vs distal radial access to see if the distal approach is not inferior compared to the conventional radial access in order to offer less or equal MACE and a similar rate of a successful procedure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • STEMI patients underwent PCI.
  • Patent radial access (distal and conventional)
  • Patients who agree to participate in the study and sign the informed consent form.

Exclusion

Exclusion Criteria:

  • Cardiogenic shock.
  • Previous coronary artery bypass grafting (CABG).
  • Absence of palpable radial pulse.
  • Arteriovenous fistula for hemodialysis.
  • Previous radial artery occlusion.

Study Design

Total Participants: 2922
Treatment Group(s): 2
Primary Treatment: percutaneous coronary intervention (PCI)
Phase:
Study Start date:
September 07, 2023
Estimated Completion Date:
February 01, 2025

Connect with a study center

  • Instituto Nacional de Cardiología Ignacio Chávez

    Mexico City,
    Mexico

    Active - Recruiting

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