Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Lef… (NCT04763200) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
United States, Canada, Germany1,252 participantsStarted 2021-04-13
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years and ≤90 years
. Clinical presentation and baseline left ventricular function are as follows: Either 2A or 2B must be present
. Local heart team (interventional cardiologist and cardiac surgeon) has determined that PCI is indicated and is the most appropriate management for the patient
. Complex PCI will be performed: Either 4A or 4B must be met
. The multiple lesions can be in the same vessel if separated by ≥10 mm - however, each separate lesion has to have one or more of the above characteristics
. PCI may be performed on additional non-qualifying lesions (i.e., without 1 or more of the above high-risk characteristics) as long as there are at least two lesions also undergoing PCI with each having 1 or more of the above characteristics)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a device called the Impella to support the heart during a high-risk PCI procedure — can you explain what that means for someone with my level of heart function, and why mechanical support might be needed in my case?
2The trial is no longer enrolling new patients but is still active — does that mean results are expected soon, and could those findings change the way you'd recommend treating my coronary artery disease?
3The trial is measuring serious outcomes like death, stroke, heart attack, and even the need for a heart transplant or LVAD — given that these are the risks being tracked, how does my current left ventricular function affect my personal risk if I were to undergo a similar procedure?
4Since this trial is in a 'not applicable' phase and focuses on a device strategy rather than a new drug, what is already known about using Impella support during high-risk PCI, and is this approach already available to me outside of a trial?
5Would you consider a standard PCI without mechanical support, or medical management alone, as a reasonable alternative for my situation, or do you think the kind of high-risk approach studied in this trial is what my condition actually requires?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The composite of all-cause death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular (CV) causes.
. There are 2 exceptions to the rule that each separate lesion must have one or more of the above characteristics (as in Inclusion Criterion 4B above): The subject may qualify if undergoing complex PCI of a single lesion that has 2 or more of the above complex characteristics (as in Inclusion Criterion 4B above) if also:
. Subject or legal guardian (permitted at US sites only) agrees to randomization and to follow all study procedures and provides informed, written consent
Exclusion criteria
. STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present (e.g., VSD, papillary muscle rupture, etc.)
. Cardiogenic shock (SBP \<80 mmHg for ≥30 mins and not responsive to intravenous fluids or hemodynamic deterioration for any duration requiring pressors or mechanical circulatory support, including IABP)
. Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for \>24 hours with full neurologic recovery)
. Cardiorespiratory arrest related to the current admission unless subject is extubated for \>24 hours with full neurologic recovery and hemodynamically stable
. Any contraindication or inability to Impella placement in both the left and right common femoral artery based on clinical or imaging findings, including iliofemoral artery diameter \<5 mm, tortuous vascular anatomy or severe bilateral peripheral vascular disease of the iliac or femoral arteries that can't be adequately treated (e.g., with intravascular lithotripsy)
. Computed tomography (CT), magnetic resonance angiography (MRA) or contrast angiography to assess the aorta and iliofemoral vasculature to ensure Impella compatibility must be performed within 90 days prior to randomization. It is recommended that this evaluation be performed prior to the index procedure. Absent a qualifying pre-procedure imaging study, contrast angiography of the potential Impella access vessel(s) must be performed in the Cath Lab before the planned enrollment after which the subject may be randomized if he/she still qualifies. Of note, if pre-procedure imaging was performed and after this test but before randomization there was a worsening in PVD symptoms, repeat imaging must be performed prior to randomization.
. If iliofemoral peripheral vascular disease is present precluding Impella use that can be adequately treated with angioplasty, atherectomy or lithotripsy (without a stent), the subject can be enrolled if such treatment is undertaken and is successful and uncomplicated - randomization must not be performed until such successful and uncomplicated treatment
. Iliofemoral stents placed within 6 months of enrollment with planned vascular access through these vascular segments