Balloon pressure monitoring for radial artery hemostasis after transradial coronary procedures: protocol for a randomized controlled trial.
X, Z., L, Z., D, Z., B, Y., J, C., T, W., Z, F., X, C., L, C., & Y, G. (2026). Balloon pressure monitoring for radial artery hemostasis after transradial coronary procedures: protocol for a randomized controlled trial.. PloS one. https://doi.org/10.1371/journal.pone.0350563
X Z, L Z, D Z, B Y, J C, T W, et al. Balloon pressure monitoring for radial artery hemostasis after transradial coronary procedures: protocol for a randomized controlled trial.. PloS one. 2026; doi: 10.1371/journal.pone.0350563
X Z, L Z, D Z, et al. Balloon pressure monitoring for radial artery hemostasis after transradial coronary procedures: protocol for a randomized controlled trial.[J]. PloS one. 2026. DOI: 10.1371/journal.pone.0350563.
@article{x2026,
author = {Zhang X and Zou L and Zhang D and Yao B and Chen J and Wei T and Fu Z and Chang X and Chen L and Geng Y},
title = {Balloon pressure monitoring for radial artery hemostasis after transradial coronary procedures: protocol for a randomized controlled trial.},
journal = {PloS one},
year = {2026},
doi = {10.1371/journal.pone.0350563},
note = {PMID: 42241412},
}
TY - JOUR AU - Zhang X AU - Zou L AU - Zhang D AU - Yao B AU - Chen J AU - Wei T AU - Fu Z AU - Chang X AU - Chen L AU - Geng Y TI - Balloon pressure monitoring for radial artery hemostasis after transradial coronary procedures: protocol for a randomized controlled trial. T2 - PloS one PY - 2026 DO - 10.1371/journal.pone.0350563 AN - PMID:42241412 ER -
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.