Transradial versus Transfemoral access for Cerebral Angiography (TRACE): study protocol for a multicenter randomized trial

Background : Transfemoral access (TFA) has been the traditional approach for diagnostic cerebral angiography, but it is associated with several limitations and complications, including pain, discomfort, retroperitoneal hemorrhage, pulmonary embolism, and increased hospital admissions. Transradial cerebral angiography (TRA) offers a promising alternative to address these issues, though its application in cerebral angiography has not been widely studied. Methods : TransRadial versus transfemoral Access for CErebral angiography (TRACE) study is a multicenter, randomized, open-label trial with blinded outcome assessment, comparing TRA and TFA for diagnostic cerebral angiography. A total of 858 participants were randomized 1:1 to TRA or TFA across 13 sites in China. The primary outcome was the success rate of diagnostic cerebral angiography, with secondary outcomes including accurate diagnosis rate, procedure duration, fluoroscopy time, flat time, and Visual Analogue Scale (VAS) score within 24 hours. Safety outcomes focused on angiographic complications. The study was powered for non-inferiority (97% TRA vs. 98% TFA success rate, -5% margin) and included an interim analysis of 430 participants reviewed by an independent Data and Safety Monitoring Board (DSMB). Recruitment ran from September 15, 2023, to November 4, 2024. Discussion : This trial will assess and compare the safety and efficacy of TRA versus TFA for diagnostic cerebral angiography. A total of 858 subjects are planned to be enrolled in this study, and randomized to the treatment group (cerebral angiography via TRA) and the control group (cerebral angiography via TFA) at the ratio of 1:1. The primary outcome is the rate of successful diagnostic cerebral angiography. Trial registration : ClinicalTrials.gov. Identifier: NCT05401669.