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

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

Abstract:

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.

Introduction

Transradial access (TRA) is currently the standard vascular access site for coronary angiography and intervention, endorsed by international guidelines due to its superior safety profile over transfemoral access [1]. Advantages include significant reductions in access-site bleeding, vascular complications, and reduction of mortality, especially in higher risk patients [2], along with improved patient comfort and cost-effectiveness [1].

Methods

The central hypothesis of this study is grounded in the following pathophysiological principle: effective hemostasis at the radial artery puncture site requires maintaining external compression pressure within a precise “therapeutic window” [2].

Discussion

TRA is the established default strategy for coronary procedures, given its demonstrated advantages in safety and patient outcomes over transfemoral access [1,2]. Despite this, forearm RAO remains the most common procedural complication [1,2], and a significant “efficacy-effectiveness gap” persists: while optimized research protocols [1] can achieve RAO rates below 5% under controlled conditions, the real-world incidence remains as high as 33% [3].

Conclusion

This trial addresses a central paradox in interventional cardiology: specifically, the reliance on a subjective, operator-dependent technique (patent hemostasis) to protect a vessel critical for future access.

Citation: Zhang X, Zou L, Zhang D, Yao B, Chen J, Wei T, et al. (2026) Balloon pressure monitoring for radial artery hemostasis after transradial coronary procedures: protocol for a randomized controlled trial. PLoS One 21(6): e0350563. https://doi.org/10.1371/journal.pone.0350563

Editor: R. Jay Widmer, Baylor Scott and White, Texas A&M College of Medicine, UNITED STATES OF AMERICA

Received: February 2, 2026; Accepted: May 13, 2026; Published: June 4, 2026

Copyright: © 2026 Zhang et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.

Funding: The funding for the trial received support from Special Research Startup Funding for Introduced Personnel of Nanjing Lishui People’s Hospital [grant number: KY07] and Nanjing Health Science and Technology Development Special Fund Project [grant number: ZDXX25202]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.