ELEVATE High-Risk PCI Pivotal Study
Purpose
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).
Condition
- High-Risk Percutaneous Coronary Intervention (High-risk PCI)
Eligibility
- Eligible Ages
- Between 18 Years and 88 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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). 2. A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option. 3. Participant signed the informed consent.
Exclusion Criteria
- Cardiogenic shock or acutely decompensated pre-existing chronic heart failure. 2. Prior stroke with any permanent, significant (mRS>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment. 3. Any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulation therapy within 90 days of the index procedure. 4. Evidence of left ventricular thrombus. 5. Aortic valve stenosis/calcification (valve area ≤ 1.5 cm2). 6. ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by transthoracic echocardiography). 7. Femoral access site incompatibility that precludes placement of either the Treatment or Control device. 8. Patient on dialysis. 9. Known or suspected coagulopathy OR abnormal coagulation parameters. 10. Known allergy, sensitivity or intolerance to nickel. 11. Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection. 12. Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT). 13. Any non-cardiac condition with a life expectancy < 12 months. 14. 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). 15. Pregnancy or breast-feeding. 16. 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. 17. Subject belongs to a vulnerable population.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is a prospective, multi-center, open-label, interventional, randomized, and controlled study with an active control group.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Elevate |
Subjects receiving the Elevate System |
|
|
Active Comparator Impella |
Subjects receiving the Impella System |
|
Recruiting Locations
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
More Details
- Status
- Recruiting
- Sponsor
- Magenta Medical Ltd.
Study Contact
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) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease. Use of the Elevate™ System in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions.