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NCT Number: NCT07686003

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Air-filled hemostatic band

Device

Simulated patent hemostasis using air-filled TR band

Primary outcomes

  1. Difference in end-diastolic velocity

    Time frame: Periprocedural

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

Secondary outcomes

  1. Flow preservation ratio

    Time frame: Periprocedural

    Flow preservation ratio in proximal and distal radial arteries

  2. Blood flow volume

    Time frame: Periprocedural

    Blood flow volume in proximal and distal radial arteries

  3. Flow volume per beat

    Time frame: Periprocedural

    Flow volume per beat in proximal and distal radial arteries

  4. Pulsatility index

    Time frame: Periprocedural

    Pulsatility index in proximal and distal radial arteries

  5. Resistance index

    Time frame: Periprocedural

    Resistance index in proximal and distal radial arteries

  6. Peak systolic velocity

    Time frame: Periprocedural

    Peak systolic velocity in proximal and distal radial arteries

  7. Velocity time integral

    Time frame: Periprocedural

    Velocity time integral in proximal and distal radial arteries

  8. Radial artery occlusion

    Time frame: up to 1 month

    Radial artery occlusion

Study contacts

Contact information is provided by the study sponsor or research team.

Jun-Won Lee, MD, PhD

CONTACT

[email protected]

Jung-Woo Son

CONTACT

[email protected]

+82-33-741-0910

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Collaborators

  • Whanin Pharmaceutical Company

Registry information

Official study title

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

Acronym: FLOW-PRADA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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