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

National Institute of Cardiology Ignacio Chavez

Status: Enrolling

Conditions: Acute Coronary Syndrome; Myocardial Infarction; STEMI - ST Elevation Myocardial Infarction

Treatments: Procedure: Radial Artery approach on percutaneous coronary intervention (PCI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06013813

23-1367

Details and patient eligibility

About

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.

Enrollment: 2,922 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,922 participants in 2 patient groups

Distal radial approach

Experimental group

Description:

* Clean and dry the puncture site. * Simple lidocaine 2% is infiltrated. * The artery is punctured in the radial distal zone, and a 6 Fr hydrophilic radial introducer is placed with the Seldinger technique. * Verapamil 2.5 mg and Heparin 5000 IU are administered. * PCI is performed. * Finally, the introducer is withdrawn with the patent hemostasis technique, and a radial compression device is placed (prelude mostly or terumo).

Treatment:

Procedure: Radial Artery approach on percutaneous coronary intervention (PCI)

Conventional radial approach (proximal radial approach).

Active Comparator group

Description:

* Clean and dry the puncture site. * Simple lidocaine 2% is infiltrated. * The artery is punctured in the radial proximal zone, and a 6 Fr hydrophilic radial introducer is placed with the Seldinger technique. * Verapamil 2.5 mg and Heparin 5000 IU are administered. * PCI is performed. * Finally, the introducer is withdrawn with the patent hemostasis technique, and a radial compression device is placed (terumo).

Treatment:

Procedure: Radial Artery approach on percutaneous coronary intervention (PCI)