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

NCT07686003 | Not Yet Recruiting

• 1 other identifier: CR326050
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemostasis of Arterial Punctures

Keywords

Distal radial access; Hemostasis

Outcome Measures

Primary Outcomes (1)

• Difference in end-diastolic velocity

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

  Periprocedural

Secondary Outcomes (8)

• Flow preservation ratio

  Periprocedural

• Blood flow volume

  Periprocedural

• Flow volume per beat

  Periprocedural

• Pulsatility index

  Periprocedural

• Resistance index

  Periprocedural

Study Arms (2)

Patent hemostasis of distal radial artery

Patent hemostasis of distal radial artery using TR band

Device: Air-filled hemostatic band

Patent hemostasis of proximal radial artery

Patent hemostasis of proximal radial artery using TR band

Device: Air-filled hemostatic band

Interventions

Air-filled hemostatic band DEVICE

Simulated patent hemostasis using air-filled TR band

Patent hemostasis of distal radial artery; Patent hemostasis of proximal radial artery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥19 years) scheduled for coronary angiography for atypical chest pain, stable angina, or acute coronary syndrome, undergoing pre-procedural transthoracic echocardiography, with palpable proximal and distal radial arteries; excluding those with cardiogenic shock, prior distal radial coronary angiography before echocardiography, inability/refusal to consent, ipsilateral arteriovenous fistula, or pregnancy/breastfeeding.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Whanin Pharmaceutical Company: collaborator
• Wonju Severance Christian Hospital: lead

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Study Officials

• Jung-Woo Son

  Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Woo Son

CONTACT

+82-33-741-0910; soneycar@gmail.com

Jun-Won Lee, MD, PhD

CONTACT

ljwcardio@yonsei.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Locations

KR (1)