ELEVATE High-Risk PCI Pivotal Study (NCT07001332) | Clinical Trial Compass
RecruitingNot Applicable
ELEVATE High-Risk PCI Pivotal Study
United States290 participantsStarted 2025-07-25
Plain-language summary
The ELEVATE III Pivotal Study is a prospective, multi-center, open-label, interventional, randomized, controlled study with an active control group. The study is intended to assess the safety and efficacy of the Elevate™ percutaneous Left Ventricular Assist Device System in patients referred to high-risk percutaneous coronary interventions (HR-PCI).
Who can participate
Age range
18 Years – 88 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
. Non-emergent, percutaneous coronary intervention is planned on at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).
. A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option.
. Participant signed the informed consent.
Exclusion criteria
. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.
. Prior stroke with any permanent, significant (mRS\>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment.
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 is focused on 'high-risk PCI' — can you help me understand whether my specific situation actually qualifies as high-risk PCI, and what that classification means for my care options?
2The trial is measuring a composite of major safety and effectiveness outcomes, but it doesn't list a traditional phase — what does that mean for what is already known about the safety of whatever device or approach is being studied here, and how does that affect the risk I'd be taking on?
3Since this is described as a 'pivotal study,' does that mean the results could be used to seek regulatory approval for a new device or procedure, and if so, how does being in a pivotal trial differ from receiving already-approved standard treatment for my condition?
4If I were enrolled, what would my care actually look like day-to-day — are there extra procedures, follow-up visits, or monitoring requirements that could be difficult given my current health or schedule?
5Before considering this trial, should we talk about whether standard high-risk PCI approaches without any investigational elements might be a better first step for my situation, and what the differences in expected outcomes might be?
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
A composite of the incidence of major safety and effectiveness parameters.
. Any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulation therapy within 90 days of the index procedure.
. Evidence of left ventricular thrombus.
. Aortic valve stenosis/calcification (valve area ≤ 1.5 cm2).
. ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by transthoracic echocardiography).
. Femoral access site incompatibility that precludes placement of either the Treatment or Control device.