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 range18 Years – 88 Years

SexALL

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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.
✕. 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.
✕. Patient on dialysis.

What they're measuring

A composite of the incidence of major safety and effectiveness parameters.

Timeframe: 30 days

Trial details

NCT IDNCT07001332

SponsorMagenta Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-16

View on ClinicalTrials.gov More High-Risk Percutaneous Coronary Intervention (High-risk PCI) trials