NCT04763200

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,252 (estimated)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Left Ventricular Dysfunction
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®	Impella CP / Impella CP with SmartAssist will be used in most patients randomized to the Impella arm. Impella 2.5 may be used in patients with small body size (BMI \<20 kg/m2 or body weight \<60 kg) or if the iliofemoral vasculature is able to accommodate the smaller Impella 2.5 device but not the Impella CP device.
DEVICE	IABP Intra-aortic balloon pump	IABP uses counterpulsation to provide 0.2L/min coronary flow

Timeline

• Start date: 2021-04-13
• Primary completion: 2026-03-01
• Completion: 2027-10-01
• First posted: 2021-02-21
• Last updated: 2026-03-06

Locations

99 sites across 7 countries: United States, Canada, Germany, Italy, Netherlands, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study