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Набор скоро начнётся NCT07686003

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

— Наблюдательное Hemostasis of Arterial Punctures

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Air-filled hemostatic band.
Кому может быть актуально
Состояния в реестре: Hemostasis of Arterial Punctures. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство Air-filled hemostatic band
    Simulated patent hemostasis using air-filled TR band

Первичные конечные точки

  • Difference in end-diastolic velocity [Срок оценки: Periprocedural]
Вторичные конечные точки (8)
  • Flow preservation ratio [Срок оценки: Periprocedural]
  • Blood flow volume [Срок оценки: Periprocedural]
  • Flow volume per beat [Срок оценки: Periprocedural]
  • Pulsatility index [Срок оценки: Periprocedural]
  • Resistance index [Срок оценки: Periprocedural]
  • Peak systolic velocity [Срок оценки: Periprocedural]
  • Velocity time integral [Срок оценки: Periprocedural]
  • Radial artery occlusion [Срок оценки: up to 1 month]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 1 центр
  • Wonju Severance Christian Hospital — Wŏnju

Идентификаторы

NCT: NCT07686003 · CR326050

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗