Impella -Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial

Brief description of study

The primary objective of the PROTECT IV Trial is to demonstrate the superiority of percutaneous coronary intervention (PCI) performed with Impella mechanical circulatory support (MCS; Impella CP®, Impella CP® with SmartAssist® or Impella 2.5® devices) compared with PCI without Impella in high-risk patients with reduced left ventricular ejection fraction undergoing percutaneous intervention of complex coronary artery disease (CAD). The principal hypothesis is that by providing effective hemodynamic support in high-risk patients with reduced left ventricular systolic function and complex CAD undergoing high-risk PCI, Impella mechanical circulatory support will facilitate a safer procedure with higher rates of optimal and complete revascularization, which will lead to improved event-free survival, quality of life (QoL) and functional outcomes at 3-year followup.


Clinical Study Identifier: s21-00560
ClinicalTrials.gov Identifier: NCT04763200
Principal Investigator: Louai Razzouk.
Other Investigators: Dimitrios Bliagos, Alexander Slotwiner, Stylianos P Papadakos, Michael Divita, Atul Sharma, Binita Shah, Justine Lachmann, Bernard Shown Kadosh, Rafael Harari, Tajinderpal Saraon, Rebecca Reich, Sripal Bangalore, Amit H. Alam, Michael J Attubato, Randal Ian Goldberg, Claudia C Serrano-Gomez, Sunil Rao.


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