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Идёт набор NCT04077762

Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)

Без фазы С лечением Patient Satisfaction Vascular Access Complication

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: Radial Access, State-of-the-art femoral access with 18 gauge needle, State-of-the-art femoral access with 21 gauge needle.
Кому может быть актуально
Состояния в реестре: Patient Satisfaction, Vascular Access Complication. Базовые параметры: от 18 лет · 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access SIte Complication Reduction in Cardiac Catheterization (REBIRTH)

Обзор

This is a phase IV, prospective, open label, randomized-controlled study that will compare radial access with state-of-the-art femoral access in patients without ST-segment elevation acute myocardial infarction undergoing cardiac catheterization. Subjects will be randomized 1:1 into 2 treatment groups: radial access and state-of-the-art femoral access. Randomization will be performed in blocks of 50 per site. Similarly, a second sub-randomization will be performed in the femoral access group into use of 18 vs 21 gauge needles, also in a 1:1 fashion.

Вмешательства

  • Процедура Radial Access
    Radial Access
  • Процедура State-of-the-art femoral access with 18 gauge needle
    State-of-the-art femoral access with 18 gauge needle
  • Процедура State-of-the-art femoral access with 21 gauge needle
    State-of-the-art femoral access with 21 gauge needle. For patients randomized to micropuncture (21G) the micropuncture wire must be advanced under fluoroscopy to avoid inadvertent wiring of side-branches.

Первичные конечные точки

  • Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5) [Срок оценки: Evaluations will occur up to 30 days]
Вторичные конечные точки (12)
  • Total number of BARC type 2, 3, or 5 bleeding events [Срок оценки: Evaluations will occur up to 30 days]
  • Number of Vascular access complications defined as the composite of arteriovenous fistula, arterial pseudoaneurysm, or arterial occlusion requiring intervention; [Срок оценки: Evaluations will occur up to 30 days]
  • Number of participants with Radial artery occlusion [Срок оценки: Evaluations will occur up to 30 days]
  • Number of participants with Access site crossover [Срок оценки: Measured during procedure]
  • Number of other vascular access related complications [Срок оценки: Evaluations will occur up to 30 days]
  • Total procedure time [Срок оценки: Measured during procedure]
  • Time to ambulation [Срок оценки: Measured up to 24 hours after procedure completion]
  • Number of all cause death and cardiac death [Срок оценки: Evaluations will occur up to 30 days]
  • Number of participants with Myocardial Infarction [Срок оценки: Evaluations will occur up to 30 days]
  • Number of participants with Stroke [Срок оценки: Evaluations will occur up to 30 days]
  • Number of participants with unplanned coronary revascularization [Срок оценки: Evaluations will occur up to 30 days]
  • Measure of Radiation Dose [Срок оценки: Measured during procedure]

Критерии участия

Критерии включения

  • Age 18 years and older
  • Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or undergoing planned urgent or elective PCI
  • Has provided informed consent and agrees to participate
  • Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access

Критерии исключения

  • Primary PCI for STEMI
  • Planned right heart catheterization
  • Valvular heart disease requiring valve surgery within 30 days after the index procedure
  • Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (the opposite arm may be used for radial access if a dialysis graft is present in one)
  • Peripheral arterial disease prohibiting vascular access
  • Presence of bilateral internal mammary artery coronary bypass grafts
  • International normalized ratio ≥1.5 while treated with oral vitamin K antagonists (i.e. warfarin) Receipt of oral factor Xa or IIa inhibitors ≤24 h before procedure
  • Planned staged PCI within 30 days after index procedure.
  • Any planned surgeries within 30 days after index procedure
  • Planned dual arterial access (for example for chronic total occlusion PCI)
  • Coexisting conditions that limit life expectancy to less than 30 days
  • Positive pregnancy test

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 6 центров
  • San Francisco VA Medical Center — San Francisco
  • Mayo Clinic Florida — Jacksonville
  • Joseph Maxwell Cleland Atlanta VA Medical Center — Decatur
  • Henry Ford Hospital — Detroit
  • Minneapolis Heart Institute Foundation — Minneapolis
  • Oklahoma Heart Hospital — Oklahoma City

Публикации

  • Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2. PMID 34637140

Идентификаторы

NCT: NCT04077762 · REBIRTH

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗