Actively Recruiting
ELEVATE High-Risk PCI Pivotal Study
Led by Magenta Medical Ltd. · Updated on 2026-04-28
290
Participants Needed
29
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
ELEVATE High-Risk PCI Pivotal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non-emergent percutaneous coronary intervention planned on at least one narrowed native coronary artery or bypass graft
- Heart team including interventional cardiologist and cardiac surgeon agrees that high-risk PCI is appropriate
- Participant has signed informed consent
You will not qualify if you...
- Cardiogenic shock or acutely worsened chronic heart failure
- Prior stroke with permanent neurological deficit or stroke/TIA within 3 months
- Any condition or planned surgery requiring stopping antiplatelet or anticoagulation therapy within 90 days
- Evidence of left ventricular thrombus
- Aortic valve stenosis or calcification with valve area 1.5 cm2 or less
- Moderate or worse aortic valve regurgitation
- Femoral access site incompatible with device placement
- Patient on dialysis
- Known or suspected blood clotting disorder or abnormal coagulation
- Allergy or intolerance to nickel
- Infection at procedural access site or active systemic infection including fever or COVID-19
- Allergy or intolerance to heparin or contrast media including heparin-induced thrombocytopenia
- Non-cardiac condition with life expectancy less than 12 months
- Participation in another investigational drug or device trial (except approved registries or observational studies)
- Pregnancy or breastfeeding
- Other medical, social, or psychological issues that compromise consent ability or study compliance
- Belongs to a vulnerable population
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, United States, 85260
Actively Recruiting
2
University of California at San Francisco Medical Center
San Francisco, California, United States, 94143
Actively Recruiting
3
Tampa General/USF
Tampa, Florida, United States, 33606
Actively Recruiting
4
Emory University Hospital / Emory University Hospital Midtown
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Wellstar Health System
Marietta, Georgia, United States, 30062
Actively Recruiting
6
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
7
St. Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
10
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
11
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01605
Actively Recruiting
13
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
14
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
15
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
16
Atlantic Health System
Morristown, New Jersey, United States, 07960
Actively Recruiting
17
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
18
Maimonides Health
Brooklyn, New York, United States, 11219
Actively Recruiting
19
Buffalo General Medical Center
Buffalo, New York, United States, 14203
Actively Recruiting
20
Northwell Health
Manhasset, New York, United States, 11030
Actively Recruiting
21
NYU Langone/Bellevue/Long Island
New York, New York, United States, 10023
Actively Recruiting
22
Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
23
Columbia University Medical Center/NYPH
New York, New York, United States, 10032
Actively Recruiting
24
Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
25
Mercy Health
Cincinnati, Ohio, United States, 45211
Actively Recruiting
26
TriStar Centennial Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
27
Inova Schar Heart & Vascular
Falls Church, Virginia, United States, 22042
Actively Recruiting
28
Swedish Cherry Hill
Seattle, Washington, United States, 98122
Actively Recruiting
29
Advocate Aurora Health Research Institute- St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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