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Flow Dynamics During Simulated Hemostasis at the Proximal and Distal Radial Arteries

Flow Dynamics During Simulated Hemostasis at the Proximal and Distal Radial Arteries: The FLOW-PRADA Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07686003
Acronym
FLOW-PRADA
Enrollment
220
Registered
2026-07-06
Start date
2026-07-01
Completion date
2026-12-31
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemostasis of Arterial Punctures

Keywords

Distal radial access, Hemostasis

Brief summary

Transradial access (TRA) has been widely adopted for coronary angiography and percutaneous coronary intervention, as it has been shown to significantly reduce bleeding complications, vascular complications, and mortality compared with transfemoral access (TFA). Based on this evidence, recent international guidelines recommend TRA as the preferred access strategy. Radial artery occlusion (RAO), a potential complication following TRA, is often clinically silent and therefore underestimated. However, RAO has important clinical implications, particularly in patients who may require repeated coronary procedures, those in whom the radial artery may be used as a conduit for coronary artery bypass grafting, or patients with chronic kidney disease requiring arteriovenous fistula formation. Therefore, maintaining radial artery patency after the procedure is of considerable clinical importance. Distal radial access (DRA), which utilizes the radial artery at the anatomical snuffbox, is a relatively recent approach. Multiple studies and meta-analyses have demonstrated that DRA provides comparable procedural success rates to TRA while significantly reducing bleeding complications and the incidence of RAO. Notably, despite the generally accepted association between smaller vessel diameter and higher risk of occlusion, DRA paradoxically shows a lower incidence of RAO. The underlying mechanism for this observation remains incompletely understood. Sgueglia et al. evaluated peak systolic velocity using Doppler ultrasonography under conditions of arterial compression and reported that antegrade blood flow was better preserved during distal radial artery compression compared with proximal radial artery compression. This finding suggests a potential mechanistic explanation for the lower incidence of RAO observed with DRA. However, there is a paucity of studies that systematically evaluate hemodynamic changes under simulated real-world hemostatic conditions at both proximal and distal radial arteries. Therefore, the aim of this study is to quantitatively assess hemodynamic changes induced by simulated occlusive hemostasis at the proximal and distal radial arteries using Doppler ultrasonography, and to elucidate the mechanisms underlying the lower incidence of RAO observed with DRA.

Interventions

DEVICEAir-filled hemostatic band

Simulated patent hemostasis using air-filled TR band

Sponsors

Wonju Severance Christian Hospital
Lead SponsorOTHER
Whanin Pharmaceutical Company
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

A. Adults aged ≥19 years B. Patients scheduled for coronary angiography due to atypical chest pain, stable angina, or acute coronary syndrome C. Patients undergoing transthoracic echocardiography for assessment of cardiac function prior to coronary angiography D. Palpable proximal and distal radial arteries

Exclusion criteria

A. Cardiogenic shock B. Patients who have undergone coronary angiography via distal radial access prior to echocardiographic evaluation C. Refusal or inability to provide informed consent D. Presence of an ipsilateral arteriovenous fistula E. Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frameDescription
Difference in end-diastolic velocityPeriproceduralDifference in end-diastolic velocity between proximal and distal radial arteries during patent hemostasis by Doppler ultrasound

Secondary

MeasureTime frameDescription
Flow preservation ratioPeriproceduralFlow preservation ratio in proximal and distal radial arteries
Blood flow volumePeriproceduralBlood flow volume in proximal and distal radial arteries
Flow volume per beatPeriproceduralFlow volume per beat in proximal and distal radial arteries
Pulsatility indexPeriproceduralPulsatility index in proximal and distal radial arteries
Resistance indexPeriproceduralResistance index in proximal and distal radial arteries
Peak systolic velocityPeriproceduralPeak systolic velocity in proximal and distal radial arteries
Velocity time integralPeriproceduralVelocity time integral in proximal and distal radial arteries
Radial artery occlusionup to 1 monthRadial artery occlusion

Countries

South Korea

Contacts

CONTACTJung-Woo Son
soneycar@gmail.com+82-33-741-0910
CONTACTJun-Won Lee, MD, PhD
ljwcardio@yonsei.ac.kr
PRINCIPAL_INVESTIGATORJung-Woo Son

Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026