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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorWonju Severance Christian Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Air-filled hemostatic band

    Device

    Simulated patent hemostasis using air-filled TR band

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Patent hemostasis of distal radial artery1 intervention
Group B: Patent hemostasis of proximal radial artery1 intervention

Trial outcomes

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

Time frame
Periprocedural

Secondary outcomes

1

Flow preservation ratio

Flow preservation ratio in proximal and distal radial arteries

Time frame
Periprocedural
2

Blood flow volume

Blood flow volume in proximal and distal radial arteries

Time frame
Periprocedural
3

Flow volume per beat

Flow volume per beat in proximal and distal radial arteries

Time frame
Periprocedural
4

Pulsatility index

Pulsatility index in proximal and distal radial arteries

Time frame
Periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wonju Severance Christian Hospital

Lead sponsor

Whanin Pharmaceutical Company

Collaborator

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