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

Not Applicable

Completed

• Conditions: ST Segment Elevation Myocardial Infarction
• Interventions: Procedure: proximal radial aretry; Procedure: distal radial artery

• Registration Number: NCT05461781
• Lead Sponsor: Beijing Luhe Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2022-01-05
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-18
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 512

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
proximal radial artery	proximal radial aretry	Proximal radial aretry for primary percutaneous coronary intervention in STEMI patients
distal radial artery	distal radial artery	Distal radial aretry for primary percutaneous coronary intervention in STEMI patients

Primary Outcome Measures

Name	Time	Method
radial artery occlusion	at 24 hours after procedure	The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Luhe hospital; 🇨🇳 Beijing, Beijing, China