Balloon pressure monitoring for radial artery hemostasis after transradial coronary procedures: protocol for a randomized controlled trial

by Xiaodong Zhang, Lan Zou, Dunfu Zhang, Bangtao Yao, Junge Chen, Tianfeng Wei, Zhouping Fu, Xin Chang, Lijuan Chen, Yan Geng

Background

Forearm radial artery occlusion (RAO) is a common complication after transradial coronary procedures. Traditional patent hemostasis, relying on operator-dependent assessment, results in labor-intensive processes and inconsistent RAO rates.

Methods

This is a single-center, prospective, randomized, open-label, parallel-group superiority trial. We plan to enroll 818 patients scheduled for transradial coronary angiography. Participants will be randomly assigned (1:1) to either a novel balloon pressure monitoring system (integrating high-precision digital manometry with physiologically-phased decompression) or traditional patent hemostasis. The primary outcome is the incidence of ultrasound-confirmed forearm RAO at 24 hours post-procedure. Key secondary outcomes include rates of access-site vascular complications and bleeding events, as well as objective metrics of hemostasis efficiency. Recruitment Status: Recruitment commenced in September 2024 and is ongoing; the target sample size is anticipated to be reached by May 2026. Analysis will follow the intention-to-treat principle.

Results/ Trial Status

As a protocol paper, no results are reported. The trial is currently in the recruitment phase.

Conclusions

This trial will provide the first large-scale randomized evidence on whether digital manometry-guided compression reduces RAO, potentially bridging the efficacy-effectiveness gap between optimized research protocols and routine practice.

Trial registration

The trial was registered with the Chinese Clinical Trial Registry (ChiCTR) in August 2024, under the registration number ChiCTR2400088258.