ELEVATE High-Risk PCI Pivotal Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-88
SponsorMagenta Medical Ltd.
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Elevate
- Impella
Treatment groups
290 Participants
are divided into 2 treatment groupsLocations
29Arizona
HonorHealth Scottsdale Shea Medical Center85260, Scottsdale United States
California
University of California at San Francisco Medical Center94143, San Francisco United States
Florida
Tampa General/USF33606, Tampa United States
Georgia
Emory University Hospital / Emory University Hospital Midtown30322, Atlanta United States
Sponsors and collaborators
Magenta Medical Ltd.
Lead sponsor
Source ClinicalTrials.gov