Status:
RECRUITING
ELEVATE High-Risk PCI Pivotal Study
Lead Sponsor:
Magenta Medical Ltd.
Conditions:
High-Risk Percutaneous Coronary Intervention (High-risk PCI)
Eligibility:
All Genders
18-88 years
Phase:
NA
Brief 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 effi...
Detailed Description
The Elevate™ percutaneous Left Ventricular Assist Device System is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) pe...
Eligibility Criteria
Inclusion
- 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
- 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.
- Known or suspected coagulopathy OR abnormal coagulation parameters.
- Known allergy, sensitivity or intolerance to nickel.
- Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection.
- Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT).
- Any non-cardiac condition with a life expectancy \< 12 months.
- Subject participation in another investigational drug or device trial (with the exception of post-market registries and observational studies, subject to Sponsor review and approval).
- Pregnancy or breast-feeding.
- Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromise the participant's ability to provide written informed consent and/or to comply with study procedures.
- Subject belongs to a vulnerable population.
Key Trial Info
Start Date :
July 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 16 2027
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT07001332
Start Date
July 25 2025
End Date
September 16 2027
Last Update
December 2 2025
Active Locations (13)
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1
Tampa General/USF
Tampa, Florida, United States, 33606
2
Wellstar Health System
Marietta, Georgia, United States, 30062
3
St. Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114