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Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function — PROTECT IV  

Coronary Artery Disease Clinical Trial

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

Clinical Trial Summary

The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.

Clinical Trial Description

To demonstrate that in high-risk patients with complex CAD and reduced left ventricular function undergoing PCI, PCI with Impella MCS is superior to PCI without Impella MCS in reducing the composite rate of all-cause death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular causes at 3-year follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04763200
Study type Interventional
Source Abiomed Inc.
Contact Charles (Chuck) Simonton, MD FACC FSCAI
Phone 978-646-1597
Email csimonton@abiomed.com
Status Recruiting
Phase N/A
Start date April 13, 2021
Completion date October 2027
View Details
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