ELEVATE High-Risk PCI Pivotal Study
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 88
Healthy Volunteers: f
View:
• 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.
Locations
United States
Florida
Tampa General/USF
RECRUITING
Tampa
Georgia
Wellstar Health System
RECRUITING
Marietta
Kentucky
St. Elizabeth Healthcare
RECRUITING
Edgewood
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Henry Ford Health
RECRUITING
Detroit
Minnesota
Minneapolis Heart Institute
RECRUITING
Minneapolis
New York
Maimonides Health
RECRUITING
Brooklyn
North Shore University Hospital
RECRUITING
Manhasset
Columbia University Medical Center/NYPH
NOT_YET_RECRUITING
New York
Mount Sinai
RECRUITING
New York
NYU Langone/Bellevue/Long Island
RECRUITING
New York
Weill Cornell Medical Center
RECRUITING
New York
Wisconsin
Advocate Aurora Health Research Institute- St. Luke's Medical Center
RECRUITING
Milwaukee
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2027-09-16
Participants
Target number of participants: 290
Treatments
Experimental: Elevate
Subjects receiving the Elevate System
Active_comparator: Impella
Subjects receiving the Impella System
Related Therapeutic Areas
Sponsors
Leads: Magenta Medical Ltd.