Hemostasis of Arterial PuncturesFLOW-PRADANCT07686003
Flow Dynamics During Simulated Hemostasis at the Proximal and Distal Radial Arteries
An observational study of Hemostasis of Arterial Punctures, run by Wonju Severance Christian Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hemostasis of Arterial Punctures
- What is being tested?
- Air-filled hemostatic band
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jun-Won Lee, MD, PhD contact
South Korea1 site
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Jung-Woo Son, MD, +82-33-741-0920, soneycar@gmail.com
Jun-Won Lee, MD, PhD, +82-33-741-0920, ljwcardio@yonsei.ac.kr
About this study
Official title: Flow Dynamics During Simulated Hemostasis at the Proximal and Distal Radial Arteries: The FLOW-PRADA Study
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.
Read more
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
- Being tested
- Air-filled hemostatic band
- Keywords
- Distal radial access, Hemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-filled hemostatic bandDevice
Simulated patent hemostasis using air-filled TR band
| Study group | Role | What they receive |
|---|---|---|
| Patent hemostasis of distal radial artery | Patent hemostasis of distal radial artery using TR band Receives: Device: Air-filled hemostatic band | |
| Patent hemostasis of proximal radial artery | Patent hemostasis of proximal radial artery using TR band Receives: Device: Air-filled hemostatic band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in end-diastolic velocity
Difference in end-diastolic velocity between proximal and distal radial arteries during patent hemostasis by Doppler ultrasound
Measured: Periprocedural
Secondary outcomes (8)
Flow preservation ratio
Flow preservation ratio in proximal and distal radial arteries
Measured: Periprocedural
Blood flow volume
Blood flow volume in proximal and distal radial arteries
Measured: Periprocedural
Flow volume per beat
Flow volume per beat in proximal and distal radial arteries
Measured: Periprocedural
Pulsatility index
Pulsatility index in proximal and distal radial arteries
Measured: Periprocedural
Resistance index
Resistance index in proximal and distal radial arteries
Measured: Periprocedural
Peak systolic velocity
Peak systolic velocity in proximal and distal radial arteries
Measured: Periprocedural
Velocity time integral
Velocity time integral in proximal and distal radial arteries
Measured: Periprocedural
Radial artery occlusion
Radial artery occlusion
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemostasis of Arterial PuncturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Whanin Pharmaceutical Company
- Responsible party
- Principal investigator, Jung-Woo Son, Wonju Severance Christian Hospital
- Investigators
- Jung-Woo Son, Principal investigator, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686003
- Sponsor's protocol ID
- CR326050
- Acronym
- FLOW-PRADA
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Dynamics During Simulated Hemostasis at the Proximal and Distal Radial Arteries: The FLOW-PRADA Study
- ClinicalTrials.gov ID
- NCT07686003
- Acronym / sponsor ID
- FLOW-PRADA / CR326050
- Conditions
- Hemostasis of Arterial Punctures
- Keywords
- Distal radial access, Hemostasis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Collaborators
- Whanin Pharmaceutical Company
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patent hemostasis of distal radial artery | – | Device: Air-filled hemostatic bandPatent hemostasis of distal radial artery using TR band |
| Patent hemostasis of proximal radial artery | – | Device: Air-filled hemostatic bandPatent hemostasis of proximal radial artery using TR band |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air-filled hemostatic bandSimulated patent hemostasis using air-filled TR band | Device | Patent hemostasis of distal radial artery, Patent hemostasis of proximal radial artery |
Primary outcome
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
8 secondary outcomes
Flow preservation ratio
Time frame: Periprocedural
Blood flow volume
Time frame: Periprocedural
Flow volume per beat
Time frame: Periprocedural
Pulsatility index
Time frame: Periprocedural
Resistance index
Time frame: Periprocedural
Peak systolic velocity
Time frame: Periprocedural
Velocity time integral
Time frame: Periprocedural
Radial artery occlusion
Time frame: up to 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hemostasis of Arterial Punctures
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Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture
Femoral Artery Puncture, Vascular Closure Device
Not yet recruiting
Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure
Hemostasis of Arterial Punctures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun-Won Lee, MD, PhD contact
Jung-Woo Son principal investigator
Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemostasis of Arterial Punctures, run by Wonju Severance Christian Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-Woo Son (+82-33-741-0910, soneycar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in end-diastolic velocity (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.