Набор скоро начнётся NCT07588399

STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI

Без фазы С лечением Coronary Artery Disease Heart Failure With Reduced Ejection Fraction

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: Impella CP.
Кому может быть актуально: Состояния в реестре: Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction. 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: Австрия
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

Randomized Pilot Study to Mechanistically Evaluate Automatic Flow Mode on Impella CP Device During Protected Complex Percutaneous Coronary Intervention

Обзор

STRATUS-PCI is a pilot clinical trial that compares two ways of running a small heart pump called Impella CP during a high-risk procedure to open blocked heart arteries (percutaneous coronary intervention, or PCI) in patients with weakened heart muscle. The pump is placed temporarily through an artery in the leg and sits across the aortic valve to help maintain blood flow during the procedure. Fifty patients will be randomly assigned in equal numbers to one of two pump settings: an automatic mode that adjusts flow up to higher levels as needed, or a fixed lower-flow mode (P-2). The doctor performing the heart procedure will not know which setting is being used (double-blind). A separate doctor monitors blood pressure and is allowed to change the pump setting at any time if the patient becomes unstable. The main question is whether the automatic mode helps doctors complete the planned heart procedure more successfully and without drops in blood pressure or other complications. Results will help design a larger future trial.

Подробное описание

STRATUS-PCI is an investigator-initiated, double-blind, randomized controlled pilot study evaluating two operating modalities of the Impella CP transvalvular axial-flow pump in patients undergoing protected complex high-risk percutaneous coronary intervention (PCI). Eligible participants are randomized 1:1 to either Impella CP Auto-mode (experimental) or Impella CP P-2 mode (active comparator, 1.3-2.1 L/min).

Вмешательства

Устройство Impella CP
The Impella CP is a transvalvular axial-flow micro-pump for temporary mechanical circulatory support, inserted via a 14F sheath into the femoral artery and positioned across the aortic valve. The pump draws blood from the left ventricle and delivers it to the ascending aorta, providing forward flow up to approximately 4.3 L/min while reducing left ventricular work and end-diastolic pressure. In this study, the device is used in all participants undergoing protected high-risk PCI, with the operat

Первичные конечные точки

Strategy Success [Срок оценки: 48 hours]

Вторичные конечные точки (4)

All-cause mortality [Срок оценки: 30 days]
Target lesion revascularization (TLR) [Срок оценки: 30 days]
Target vessel myocardial infarction (TV-MI) [Срок оценки: 30 days]
Early stent thrombosis [Срок оценки: 30 days]

Критерии участия

Критерии включения

signed written informed consent
age ≥ 18 years
presentation in chronic coronary syndrome or acute coronary syndrome (STEMI ≥ 24h)
LV-EF ≤ 40 % and one of the following parameters:

Last remaining artery Unprotected LM-PCI + severe RCA stenosis or CTO Unprotected LM-PCI + left dominance Unprotected LM-PCI + severe aortic stenosis Unprotected LM-PCI + severe mitral regurgitation RCA PCI + unprotected severe LM stenosis RCA PCI + proximal LAD stenosis + proximal LCx stenosis