- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07686003
Flow Dynamics During Simulated Hemostasis at the Proximal and Distal Radial Arteries (FLOW-PRADA)
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.
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Jun-Won Lee, MD, PhD
- E-Mail: ljwcardio@yonsei.ac.kr
Studieren Sie die Kontaktsicherung
- Name: Jung-Woo Son
- Telefonnummer: +82-33-741-0910
- E-Mail: soneycar@gmail.com
Studienorte
-
-
Gangwon-do
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Wŏnju, Gangwon-do, Südkorea, 26426
- Wonju Severance Christian Hospital
-
Kontakt:
- Jung-Woo Son, MD
- Telefonnummer: +82-33-741-0920
- E-Mail: soneycar@gmail.com
-
Kontakt:
- Jun-Won Lee, MD, PhD
- Telefonnummer: +82-33-741-0920
- E-Mail: ljwcardio@yonsei.ac.kr
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Patent hemostasis of distal radial artery
Patent hemostasis of distal radial artery using TR band
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Simulated patent hemostasis using air-filled TR band
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Patent hemostasis of proximal radial artery
Patent hemostasis of proximal radial artery using TR band
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Simulated patent hemostasis using air-filled TR band
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Difference in end-diastolic velocity
Zeitfenster: Periprocedural
|
Difference in end-diastolic velocity between proximal and distal radial arteries during patent hemostasis by Doppler ultrasound
|
Periprocedural
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Flow preservation ratio
Zeitfenster: Periprocedural
|
Flow preservation ratio in proximal and distal radial arteries
|
Periprocedural
|
|
Blood flow volume
Zeitfenster: Periprocedural
|
Blood flow volume in proximal and distal radial arteries
|
Periprocedural
|
|
Flow volume per beat
Zeitfenster: Periprocedural
|
Flow volume per beat in proximal and distal radial arteries
|
Periprocedural
|
|
Pulsatility index
Zeitfenster: Periprocedural
|
Pulsatility index in proximal and distal radial arteries
|
Periprocedural
|
|
Resistance index
Zeitfenster: Periprocedural
|
Resistance index in proximal and distal radial arteries
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Periprocedural
|
|
Peak systolic velocity
Zeitfenster: Periprocedural
|
Peak systolic velocity in proximal and distal radial arteries
|
Periprocedural
|
|
Velocity time integral
Zeitfenster: Periprocedural
|
Velocity time integral in proximal and distal radial arteries
|
Periprocedural
|
|
Radial artery occlusion
Zeitfenster: up to 1 month
|
Radial artery occlusion
|
up to 1 month
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Jung-Woo Son, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- CR326050
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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