Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures

Официальное название

Chronic Total Occlusion (CTO) Crossing, Re-entry and Imaging With the Acolyte™ Catheter System in Subjects Undergoing Percutaneous Coronary Interventional (PCI) Procedures

Обзор

This is a study to evaluate the safety and effectiveness of the Acolyte Catheter System used in CTO-PCI procedures. The system will be used for the placement and positioning of guidewires and catheters in the coronary vasculature for the treatment of patients with coronary chronic total occlusions with persistent symptoms following medical therapy.

Подробное описание

This is a study to evaluate the safety and effectiveness of the Acolyte™ Catheter System used in CTO-PCI procedures as follows:

* Evaluate angiographic confirmation of guidewire placement beyond the CTO, in the true vessel lumen, in which the investigational device was utilized to facilitate crossing and/or re-entry. * Evaluate in-hospital major adverse cardiac events (MACE).

Acolyte™ Optical Coherence Tomography (OCT) imaging will be utilized in all cases to inform guidewire advancement in the direction of true lumen. Additionally, Acolyte™ OCT imaging will be used to guide re-entry from the subintimal space to the true lumen.

Вмешательства

• Устройство CTO-PCI Procedure with Acolyte Catheter System
  Acolyte Catheter System is used to facilitate placement and positioning of guidewires and catheters within the coronary vasculature for the treatment of patients with coronary chronic total occlusions with persistent symptoms following medical therapy. The device provides real-time visualization of a coronary chronic total occlusion allowing for guidewire placement in the true lumen of the target vessel and subsequent revascularization.

Первичные конечные точки

• Procedure Success - Visualization of Guidewire [Срок оценки: From the beginning of the study procedure to the end of the study procedure]
• Procedure Success - Absence of Major Adverse Cardiac Events [Срок оценки: From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)]

Вторичные конечные точки (12)

• Successful Recanalization [Срок оценки: From the beginning of the study procedure to the end of the study procedure]
• In-Hospital: Frequency of Major Adverse Cardiac Events (MACE) [Срок оценки: From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)]
• 30-Day: Frequency of Major Adverse Cardiac Events (MACE) [Срок оценки: 30 Day Follow-up]
• Safety - Blood Vessel Perforation [Срок оценки: From the beginning of the study procedure to the end of the study procedure]
• Procedure: Serious Adverse Events Related to Study Device or Procedure [Срок оценки: From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)]
• 30-Day: Serious Adverse Events Related to Study Device or Procedure [Срок оценки: 30 Day Follow-up]
• 3-Month: Serious Adverse Events Related to Study Device or Procedure [Срок оценки: 3-Month Follow-up]
• Procedure: Non-serious Adverse Events Related to Study Device or Procedure [Срок оценки: From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)]
• 30-Day: Non-serious Adverse Events Related to Study Device or Procedure [Срок оценки: 30 Day Follow-up]
• Procedure: Time for Guidewire to Cross Chronic Total Occlusion (CTO) [Срок оценки: From the beginning of the study procedure to the end of the study procedure]
• Procedure: Fluoroscopy Time [Срок оценки: From the beginning of the study procedure to the end of the study procedure]
• Procedure: Technical Success [Срок оценки: From the beginning of the study procedure to the end of the study procedure]

Критерии участия

Критерии включения

• Subject is > 18 years of age at the time of consent
• Subject is on medical therapy and continues to experience clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization
• Female subjects of reproductive potential must have a negative pregnancy test per standard of care for PCI
• Subject is willing and able to provided written informed consent
• Subject is willing to and able to comply with the study protocol requirements including all follow up visits post-procedure

Критерии исключения

• Subject has history of allergy to iodinated contrast that cannot be managed medically
• Subject has evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment
• Subject has had previous coronary interventional procedure of any kind within 30 days prior to the investigational procedure
• Atherectomy procedure is planned for the target lesion
• History of stroke or transient ischemic attack within 6 months prior to procedure
• Active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to procedure
• History of bleeding diathesis or coagulopathy or refusal of blood transfusions
• Other pathology such as cancer, known mental illness, etc., or other condition which might, in the opinion of the Investigator, put the patient at risk or confound the results of the study
• Subject participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with this study's endpoints; or requires coronary angiography, intravascular ultrasound, or other coronary artery imaging procedures

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 · 5 центров

• Piedmont Heart Institute — Atlanta
• Emory University Hospital — Atlanta
• Minneapolis Heart Institute Foundation — Minneapolis
• St. Francis Hospital — Roslyn
• PharmaTex Research — Amarillo

Идентификаторы

NCT: NCT06795763 · CP24001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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