ELEVATE High-Risk PCI Pivotal Study
Status: Recruiting
Location: See all (6) 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
Kentucky
St. Elizabeth Healthcare
RECRUITING
Edgewood
New York
North Shore University Hospital
RECRUITING
Manhasset
Mount Sinai
RECRUITING
New York
NYU Langone/Bellevue/Long Island
RECRUITING
New York
Weill Cornell Medical Center
RECRUITING
New York
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.