ELEVATE High-Risk PCI Pivotal Study
Status: Recruiting
Location: See all (29) 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
Arizona
HonorHealth Scottsdale Shea Medical Center
RECRUITING
Scottsdale
California
University of California at San Francisco Medical Center
RECRUITING
San Francisco
Florida
Tampa General/USF
RECRUITING
Tampa
Georgia
Emory University Hospital / Emory University Hospital Midtown
RECRUITING
Atlanta
Wellstar Health System
RECRUITING
Marietta
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Kentucky
St. Elizabeth Healthcare
RECRUITING
Edgewood
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Boston Medical Center
RECRUITING
Boston
Brigham & Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
UMass Memorial Medical Center
RECRUITING
Worcester
Michigan
Henry Ford Health
RECRUITING
Detroit
Minnesota
Minneapolis Heart Institute
RECRUITING
Minneapolis
Missouri
St. Luke's Hospital of Kansas City
RECRUITING
Kansas City
New Jersey
Atlantic Health System
RECRUITING
Morristown
Robert Wood Johnson University Hospital
RECRUITING
New Brunswick
New York
Maimonides Health
RECRUITING
Brooklyn
Buffalo General Medical Center
RECRUITING
Buffalo
Northwell Health
RECRUITING
Manhasset
Columbia University Medical Center/NYPH
RECRUITING
New York
Mount Sinai
RECRUITING
New York
NYU Langone/Bellevue/Long Island
RECRUITING
New York
Weill Cornell Medical Center
RECRUITING
New York
Ohio
Mercy Health
RECRUITING
Cincinnati
Tennessee
TriStar Centennial Medical Center
RECRUITING
Nashville
Virginia
Inova Schar Heart & Vascular
RECRUITING
Falls Church
Washington
Swedish Cherry Hill
RECRUITING
Seattle
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.