PROTECT IV RCT
Impella 2.5® or Impella CP® Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function
Trial Objective:
To demonstrate that in high-risk patients with complex CAD and reduced left ventricular function undergoing PCI, PCI with Impella 2.5 or Impella CP is superior to PCI without Impella 2.5 or Impella CP 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 three-year follow-up.
Impella 2.5® is no longer commercially available in the United States.
Study Design
The intent of the PROTECT IV RCT is to leverage and validate the best practices that we have learned over the past 10 years in the PROTECT series and cVAD studies that led to the FDA PMA approval of Impella 2.5® or Impella CP® for high-risk PCI.
Patients Randomized 1:1
Key Inclusion Criteria
- Patients with Chronic Coronary Syndrome (CCS), NSTEMI, or STEMI after 24 hours of onset and have an LVEF of <30%
- Complex coronary disease
- Age ≥18 years and ≥90 years
- Local heart team has determined that PCI is indicated and is the most appropriate management for the patient
- Subject or legal guardian (permitted at US sites only) agrees to randomization and to follow all study procedures and provides informed, written consent
Key Exclusion Criteria
- No prior CABG or PCI within 12 months
- No moderate/severe RV dysfunction
- No severe aortic stenosis
- Not on dialysis
- STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present
- Not in Cardiogenic Shock
Other important safety information can be found at https://www.abiomed.com/important-safety-information
NPS-4322