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

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

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.

Study Overview

• Status: Completed
• Conditions: ST Segment Elevation Myocardial Infarction
• Intervention / Treatment: Procedure: distal radial access; Procedure: conventional transradial access

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 512
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 101149
      • Beijing Luhe hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: distal radial access; Distal radial access for primary percutaneous coronary intervention in STEMI patients	Procedure: distal radial access; primary percutaneous coronary intervention via distal radial access
Active Comparator: conventional transradial access; conventional transradial access for primary percutaneous coronary intervention in STEMI patients	Procedure: conventional transradial access; primary percutaneous coronary intervention via conventional transradial access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radial artery occlusion	The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound.	at 24 hours after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of successful puncture	Successful puncture occurs when an introducer sheath can be properly placed through the punctured artery.	Immediately post-procedurally
puncture time	The puncture time was defined as the time interval between local anesthesia induction and successful sheath insertion.	Immediately post-procedurally
first medical contact to device (FMC2D) time	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.	Immediately post-procedurally
procedural time	Procedural time defined as the time interval between local anesthesia to sheath removal.	Immediately post-procedurally
hemostasis time	Hemostasis time was defined as the time between sheath removal to complete hemostasis.	at 24 hours after procedure
access-related complications	Access-related complications include AV fistula formation, pseudoaneurysm, and local haematoma.	at 24 hours after procedure
hand function	Hand function was evaluated by QuickDASH questionnaire.	1 week after procedure
radial artery occlusion	The radial artery occlusion will be evaluated 1 month after procedure by ultrasound.	30days after procedure
radial aretry injury	Radial aretry injury including intimal tears, dissections, perforation and thrombosis was detected by optical coherence tomography.	Immediately post-procedurally
major adverse cardiovascular events(MACE)	MACE was defined as all-cause death, any myocardial infarction, stroke and major bleeding.	30 days after procedure

Collaborators and Investigators

• Sponsor: Beijing Luhe Hospital
• Investigators: Study Chair: Jincheng Guo, Beijing Luhe hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: radial artery occlusion; primary percutaneous coronary intervention; distal radial access; conventional transradial access
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; ST Elevation Myocardial Infarction; Myocardial Infarction; Infarction
• Other Study ID Numbers: Beijing LH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No