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

NCT04763200 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1252

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Abiomed Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2026-03-31
Completion
2027-10-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04763200 on ClinicalTrials.gov