Идёт набор NCT07479433

The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI

— Наблюдательное Coronary Artery Disease (CAD)

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: Heartflow PCI Navigator.
Кому может быть актуально: Состояния в реестре: Coronary Artery Disease (CAD). 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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Обзор

The objective of Heartflow's NAVIGATE-PCI Registry is to collect observational data about the management of patients before and after deployment of Heartflow's PCI Navigator.

Подробное описание

Heartflow's NAVIGATE-PCI Registry is a post-market, multi-center, data collection registry assessing confidence in procedure planning, time of procedure, contrast usage during procedure, radiation usage during procedure, invasive imaging (angiographic or other), and resource utilization. Sites will provide retrospective data from patients receiving an elective PCI prior to the deployment of PCI Navigator vs. after deployment and operator training on how to use the information provided by PCI Navigator. Baseline demographic, medical history, procedural, and in-hospital outcome information will be collected following the procedure. No post discharge follow-up data will be collected.

Вмешательства

Диагностический тест Heartflow PCI Navigator
Heartflow PCI Navigator is the only integrated, AI-driven PCI planning tool that gives interventional cardiologists a patient-specific 3D model, detailing anatomy, plaque composition, and lesion-specific physiology, all aligned to optimize potential stent placement. PCI Navigator delivers a streamlined view of essential information for cath lab decision-making by integrating all relevant measurements, including IVUS-like and FFR-like pullback visualizations, into one seamless experience, which t

Первичные конечные точки

Primary Endpoint [Срок оценки: 90 Days]

Вторичные конечные точки (6)

Changes in confidence with and without PCI Navigator (assessed in Groups 2 and 3 as two separate analyses) [Срок оценки: 90 days for Group 2, 18 months for Group 3]
Change in procedural time with and without PCI Navigator [Срок оценки: 90 days]
Change in contrast usage with and without PCI Navigator [Срок оценки: 90 days]
Change in radiation usage during PCI with and without PCI Navigator [Срок оценки: 90 days]
Change in invasive imaging (angiographic or other) with and without PCI Navigator [Срок оценки: 90 days]
Change in resource utilization with and without PCI Navigator [Срок оценки: 90 days]

Критерии участия

Inclusion Criteria (all must be present):

CCTA completed ≤90 days prior to elective PCI with acceptable image quality according to Heartflow's image quality requirements
Referred for elective PCI
Clinically stable without symptoms suggestive of acute coronary syndrome (ACS) at the time of the intervention

Exclusion Criteria (all must be present):