Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® for Coronary Artery Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Coronary Artery Disease+1 MoreImpella CP® / Impella CP® with SmartAssist® / Impella 2.5® - Device
Eligibility
18 - 90
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if using a heart pump called Impella during high-risk heart procedures helps improve symptoms, heart function, and health better than the current standard of care.

Eligible Conditions
  • Coronary Artery Disease
  • Left Ventricular Dysfunction

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: 3 years

1 year
Death or NYHA Class III or IV
3 years
Achievement of complete anatomic revascularization after the index and planned staged procedures
All CV hospitalizations
All CV hospitalizations through 3 years
CV death or HF hospitalizations
CV death or HF hospitalizations through 3 years
Complete ischemic revascularization evaluated using Pearson's chi-square test for proportion difference
Myocardial Infarction
Composite of CV death, stroke, durable LVAD implant or heart transplant, MI or hospitalization for cardiovascular cause through 3 years
The composite of all-cause death, stroke, MI or hospitalization for cardiovascular (CV) causes.
The composite of all-cause death, stroke, durable LVAD implant or heart transplant, MI or hospitalization for cardiovascular (CV) causes.
6 months
6MWD
Baseline to 6 months
Improvement in KCCQ
Improvement in LVEF based on ANCOVA regression with inclusion of baseline LVEF measurement as a covariate

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control Arm
1 of 2
Impella Arm
1 of 2

Active Control

Experimental Treatment

1252 Total Participants · 2 Treatment Groups

Primary Treatment: Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® · No Placebo Group · N/A

Impella Arm
Device
Experimental Group · 1 Intervention: Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® · Intervention Types: Device
Control Arm
Device
ActiveComparator Group · 1 Intervention: IABP Intra-aortic balloon pump · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Abiomed Inc.Lead Sponsor
35 Previous Clinical Trials
32,248 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
868 Patients Enrolled for Coronary Artery Disease

Eligibility Criteria

Age 18 - 90 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Clinical presentation: Either two A's or two B's must be present
A subject who has had a STEMI (a heart attack caused by a blocked blood vessel) in the past month and has an LVEF (left ventricular ejection fraction, a measure of how well the left ventricle of the heart is pumping) of 30% or less may be eligible for enrollment in the study
The local heart team has determined that PCI is the most appropriate management for the patient.
An adult is any human who is at least 18 years old and no older than 90 years old.
If there is a narrowing of the left main artery that is greater than 50% (or 30% if there is evidence of ischemia on both the anterior and posterolateral distributions), and if there is planned intervention of the left main artery and at least 2 other branch vessels, then this is considered to be left main distal bifurcation or trifurcation disease.
Triple vessel disease is present when there is evidence of ischemia in all three of the epicardial coronary artery distributions in a main vessel or branch with a visually-assessed reference vessel diameter of at least 2.5 mm
If the patient's coronary artery is blocked, the last remaining vessel (native coronary artery or bypass graft) can be used to try and improve the blood flow.
Left main equivalent disease is present when there is significant blockage in both the left anterior descending (LAD) and left circumflex (LCX) coronary arteries

Who else is applying?

What state do they live in?
New Jersey100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Robert Wood Johnson Medical School & Robert Wood Johnson University Hospital100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%