Abstract Body: Background: Transfemoral access (TFA) has traditionally been used for diagnostic cerebral angiography, but it is associated with several limitations and complications, such as pain, discomfort, retroperitoneal hemorrhage, pulmonary embolism, and increased hospital admissions. In contrast, transradial access (TRA) is a newer approach that offers several advantages, including reduced damage, easier hemostatic management, lower complication rates, and shorter bed rest requirements. While transradial cerebral angiography addresses many of the limitations of the TFA, it has not yet to become the primary option due to limited experience and the availability of relevant materials. Currently, TRA is typically considered when TFA is unsuccessful or challenging to perform. This randomized controlled trial aims to compare the safety and efficacy of TRA and TFA in cerebral angiography. The findings are expected to provide robust evidence to support the broader adoption of TRA in clinical practice.
Methods: TRACE is an investigator-initiated, multi-center, prospective, open-label parallel group trial with blinded outcome assessment (PROBE design) assessing superiority of TRA versus TFA for cerebral angiography. The study aimed to enroll and randomize a total of 858 subjects scheduled for diagnostic cerebral angiography in a 1:1 ratio between TRA (intervention) and TFA (control) across 13 centers in China. The primary outcome is the rate of successful diagnostic cerebral angiography. The secondary outcomes include the rate of successful and accurate diagnostic cerebral angiography, the duration of angiography and fluoroscopy, flat time and visual analogue scale (VAS) score between the randomized treatment groups.
Results: From September 2023 to October 2024, 858 subjects were enrolled. The primary endpoint evaluation for all subjects will be conducted by an independent core lab and clinical outcome committee. Data on demographics, intraoperative details, and available safety and effectiveness results will be presented at the time of this presentation.
Conclusion: TRA is a safe and effective approach for cerebral angiography, demonstrating a success rate comparable to TFA, while being associated with fewer complications.