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Идёт набор NCT06193954

VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions

Без фазы С лечением Chronic Total Occlusion of Coronary Artery Chronic Angina

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: VasoStar guidewire system.
Кому может быть актуально
Состояния в реестре: Chronic Total Occlusion of Coronary Artery, Chronic Angina. 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

Evaluation of a Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions in Patients With Chronic Angina Refractory to Maximally Tolerated Guideline Directed Medical Therapy

Обзор

The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.

Подробное описание

This Early Feasibility Study (EFS) is proposed to evaluate the initial safety and efficacy of the VasoStar guidewire system to cross complex coronary vascular lesions in non-tortuous arterial segments which are resistant to crossing with a traditional interventional guidewire.

Вмешательства

  • Устройство VasoStar guidewire system
    The VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a wire with an electromagnetic source.

Первичные конечные точки

  • Number of participants with successful crossing of the target lesion with the VasoStar guidewire system [Срок оценки: 1 day]
  • Incidence of Treatment-Emergent Serious Adverse Events [Срок оценки: 30 days]
Вторичные конечные точки (6)
  • Improved 6-minute walk distance at 6 months following the VasoStar successful procedure [Срок оценки: 6 months]
  • Improved 6-minute walk distance at 12 months following the VasoStar successful procedure [Срок оценки: 12 months]
  • Improved score on the Seattle Angina Questionnaire at the 6-month visit compared to the score at baseline [Срок оценки: 6 months]
  • Improved score on the Seattle Angina Questionnaire at the 12-month visit compared to the score at baseline [Срок оценки: 12 months]
  • Reduced number of hospitalizations for cardiac symptoms within 1 year following the VasoStar procedure, compared to the reported number of hospitalizations following standard CTO procedures. [Срок оценки: 1 year]
  • Reduced number of emergency room visits for cardiac symptoms within 1 year following the VasoStar procedure, compared to the reported number of hospitalizations following standard CTO procedures. [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Male or female, over 18 years of age, presenting with at least one ischemia inducing lesion in a native coronary artery that is refractory to standard guidewire crossing. Chronic total occlusion (CTO) is defined as 100% coronary blockage for over a 3-month duration documented either by prior catheterization or by clinical evaluation
  • Suitable candidate for non-emergent, coronary angioplasty
  • Documented de-novo or restenotic coronary chronic total occlusion defined as a lesion with TIMI 0 flow for at least 90 days refractory to conventional guidewire crossing
  • Left ventricle ejection fraction > 20% within the last 12 months.
  • For antegrade chronic total occlusion procedures, activated clotting time (ACT) should be > 300 sec
  • Chronic total occlusion in a non-tortuous arterial segment
  • Voluntarily sign a Patient Informed Consent Form specific to the study.
  • Physically and mentally willing to comply with all study requirements.

Критерии исключения

  • Successful target lesion crossing with a conventional wire system prior to enrollment
  • Prisoners.
  • Pregnancy
  • Patient has an active implantable.
  • Extensive dissection created by refractory guidewire
  • Severe ongoing congestive heart failure (New York Heart Association Class IV symptoms)
  • Active infection
  • Uncontrolled Hypertension (Systolic blood pressure > 180 mm) at the time of the procedure
  • History of severe reaction to contrast media
  • Recent myocardial infarction (within 2 weeks)
  • In-stent target lesion
  • Severe cerebrovascular disease including history of prior stroke or transient ischemic attack within 1 month at the time of the procedure
  • Saphenous vein graft (SVG) chronic total occlusion or an in-stent chronic total occlusion
  • Short life expectancy due to other illnesses such as cancer or pulmonary, hepatic or renal disease
  • Participation in another investigational protocol at the time of the procedure

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Emory University — Atlanta
  • Summa Health — Akron

Идентификаторы

NCT: NCT06193954 · VST100

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗