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

Capital Medical University

Status: Completed

Conditions: ST Segment Elevation Myocardial Infarction

Treatments: Procedure: conventional transradial access; Procedure: distal radial access

Study type: Interventional

Funder types: Other

Identifiers

NCT05461781

Beijing LH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 512 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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512 participants in 2 patient groups

distal radial access

Experimental group

Description:

Distal radial access for primary percutaneous coronary intervention in STEMI patients

Treatment:

Procedure: distal radial access

conventional transradial access

Active Comparator group

Description:

conventional transradial access for primary percutaneous coronary intervention in STEMI patients

Treatment:

Procedure: conventional transradial access