Distal Radial Artery Access With 6F and 7F Thin-Walled Sheaths for Coronary Intervention: A Multicentre, Randomized,...

Distal radial artery access (dTRA) reduces radial artery occlusion (RAO) and improves safety compared with conventional transradial access, yet its use in complex coronary interventions necessitating larger guiding catheters remains limited. Thin-walled 7F sheaths with reduced external diameter may overcome this barrier. We present the protocol for a multicentre, randomized, open-label, noninferiority trial enrolling 574 patients aged 18 to 80 years with distal radial artery diameter ≥ 1.7 mm who are scheduled for elective percutaneous coronary intervention (PCI) across 5 Chinese centres. Participants are centrally randomized 1:1 to receive either a 7F thin-walled sheath (experimental) or a 6F thin-walled sheath (control) via dTRA. The primary endpoint is RAO and distal RAO at 24 hours, evaluated by Doppler ultrasound. Secondary endpoints include cannulation and procedural success, crossover to alternative access, RAO and distal RAO at 30 days, hematoma (EASY scale), major bleeding (BARC), pain (VAS), functional status (Barthel Index), length of stay, and total hospitalization costs. Data are collected pre-, intra-, and postprocedure, with follow-up at 24 hours and 30 days. Results will provide robust evidence on the safety and efficacy of 7F thin-walled sheaths in dTRA for complex PCI, informing optimal equipment selection and procedural strategies. CLINICAL TRIAL REGISTRATION: NCT06585917.