CompletedNot Applicable

Magenta Elevate™ EFS in High-Risk PCI Patients

United States18 participantsStarted 2023-05-08

Plain-language summary

The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.

Who can participate

Age range

18 Years – 84 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 in at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).
. Ejection fraction of ≤ 50% and at least one of the following:
. Intervention on an unprotected left main coronary artery
. Intervention on a last patent coronary conduit
. Three-vessel disease (in case of left coronary artery dominance, the combination of a left anterior descending artery (LAD) lesion and a proximal left circumflex artery (LCX) lesion qualifies as three-vessel disease).
. A heart team that includes a cardiac surgeon has determined that high-risk PCI is the appropriate therapeutic option.
. Subject signed informed consent.

Exclusion criteria

. Subject age \< 18 or ≥ 85 years.
. Cardiogenic shock (systolic blood pressure \< 90 mmHg with evidence of end organ hypoperfusion, such as cool extremities or urine \< 30 mL/hour); acutely decompensated pre-existing chronic heart failure; any use of inotropic or vasopressor in the previous 48 hours; or any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days.

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Rate of Major Device-Related Adverse Events (MDRAE)

Timeframe: From device delivery through device removal (up to 6 hours)

Rate of successful initiation and maintenance of hemodynamic support without Severe Hypotension

Timeframe: From device delivery through device removal (up to 6 hours)

Trial details

NCT IDNCT05727059

SponsorMagenta Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-01

View on ClinicalTrials.gov More High-risk Percutaneous Coronary Intervention trials