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Impella-Supported PCI for Coronary Heart Disease (PROTECT IV Trial)

N/A
Recruiting
Research Sponsored by Abiomed Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
OR B. Subject has STEMI ≥24 hours and <30 days after symptom onset with an LVEF ≤30% NOTE: In patients qualifying with recent STEMI, the LVEF must be demonstrated to be ≤30% by quantitative echocardiography after the primary PCI procedure (if performed) and within 72-hours prior to the planned randomization. If primary PCI was not performed, the qualifying echocardiogram will be the one taken during the index hospitalization closest to the index procedure. If the site read is qualitative only (i.e., only provides broad ranges without detailed LVEF quantification), the Echo Core Lab must confirm the LVEF is ≤30% before subject enrollment.
Age ≥18 years and ≤90 years
Must not have
Various cardiovascular and medical conditions (e.g., iliofemoral artery diameter <5 mm, severe bilateral peripheral vascular disease, ventricular arrhythmias, aortic stenosis, prior mechanical valve or self-expanding TAVR, prior CABG within three months, severe pulmonary hypertension, severe RV dysfunction, severe tricuspid insufficiency, platelet count <75,000 cells/mm3, on dialysis, prior stroke within the previous three months, chronic oral anticoagulant use, plan for surgery within 6 months necessitating discontinuing antiplatelet agents)
STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
Adults aged 18-90 with complex coronary artery disease, reduced left ventricular function (LVEF ≤40% or ≤30% in specific cases), and planned high-risk PCI. Candidates must not have life-threatening non-cardiac conditions, recent severe heart attacks, cardiogenic shock, pregnancy, or other serious medical issues that could affect participation.
What is being tested?
The trial is testing whether using the Impella® devices during high-risk percutaneous coronary intervention (PCI) improves symptoms and heart function compared to standard care with an intra-aortic balloon pump in patients with significant heart vessel blockage and weakened heart pumping ability.
What are the potential side effects?
Potential side effects of using Impella® devices may include bleeding at the catheter insertion site, blood vessel damage, irregular heartbeat, blood clots leading to stroke or other problems; however individual experiences can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a severe heart attack between 1 to 30 days ago and my heart's pumping ability is very weak.
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I am between 18 and 90 years old.
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I have severe blockages in all three main heart arteries and plan to have stent placement in at least two.
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My heart's pumping ability is reduced due to a recent heart attack.
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I had a procedure on my last unblocked heart vessel.
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I have severe blockages in the main arteries of my heart that need treatment.
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My heart team has recommended a procedure to open my heart's blocked arteries.
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I am scheduled for a complex PCI procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe heart, blood, or vascular conditions that would exclude me.
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I had a severe heart attack within the last 24 hours or have complications from a heart attack.
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I have a non-heart related condition that may shorten my life to under 3 years.
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I am currently in the hospital for COVID-19.
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I can have an Impella device placed in my arteries without issues.
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I have experienced a severe heart condition known as cardiogenic shock.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Impella ArmExperimental Treatment1 Intervention
Impella CP® or Impella 2.5 placement prior to high-risk PCI
Group II: Control ArmActive Control1 Intervention
Subjects randomized to the Control group will be treated per standard of care PCI with or without an intra-aortic balloon pump (IABP).

Find a Location

Who is running the clinical trial?

Abiomed Inc.Lead Sponsor
44 Previous Clinical Trials
32,356 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
868 Patients Enrolled for Coronary Artery Disease

Media Library

Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® Clinical Trial Eligibility Overview. Trial Name: NCT04763200 — N/A
Coronary Artery Disease Research Study Groups: Impella Arm, Control Arm
Coronary Artery Disease Clinical Trial 2023: Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® Highlights & Side Effects. Trial Name: NCT04763200 — N/A
Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® 2023 Treatment Timeline for Medical Study. Trial Name: NCT04763200 — N/A
~302 spots leftby Mar 2026
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