ELEVATE High-Risk PCI Pivotal Study
Magenta Medical Ltd.
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).
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.
Eligibility
- Age range
- 18–88 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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: 1. 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…
Interventions
- DeviceElevate
The Elevate System is a catheter- mounted, self-expanding and retrievable, continuous-flow pump, designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta, thus augmenting cardiac output and maintaining systemic arterial pressure during complex/high-risk coronary interventions. Subjects will receive an Elevate prior to their high-risk percutaneous intervention.
- DeviceImpella
Subjects will receive an Impella prior to their high-risk percutaneous intervention.
Locations (29)
- HonorHealth Scottsdale Shea Medical CenterScottsdale, Arizona
- University of California at San Francisco Medical CenterSan Francisco, California
- Tampa General/USFTampa, Florida
- Emory University Hospital / Emory University Hospital MidtownAtlanta, Georgia
- Wellstar Health SystemMarietta, Georgia
- University of Chicago Medical CenterChicago, Illinois