Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention Impella ECP Continued Access Protocol
Status: Enrolling_by_invitation
Location: See all (32) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The Impella ECP Study is a prospective, multi-center, single-arm study evaluating the rate of major adverse cardiovascular and cerebrovascular events (MACCE) with the Impella ECP device in adult patients undergoing elective or urgent high-risk percutaneous coronary intervention. The above applies to Impella ECP Continued Access Protocol
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• Age ≥18 years and ≤90 years
• Subject signed the informed consent
• Subject is hemodynamically stable and a heart team, including a cardiac surgeon, has determined that an elective or urgent (not emergent) high-risk PCI is the appropriate therapeutic option
Locations
United States
Arkansas
Arkansas Heart Hospital
Little Rock
Arizona
St. Joseph's Medical Center - Phoenix
Phoenix
Tucson Medical Center/ PIMA Heart & Vascular
Tucson
California
Adventist Health Glendale
Glendale
Keck Hospital of USC
Los Angeles
Loma Linda University Medical Center
San Bernardino
Florida
Manatee Memorial Hospital
Bradenton
North Florida Regional Medical Center
Gainesville
AdventHealth - Tampa
Tampa
Georgia
Emory University Hospital
Atlanta
Louisiana
Ochsner Foundation Hospital
New Orleans
Massachusetts
Tufts Medical Center
Boston
Michigan
Ascension St. John Hospital
Detroit
Henry Ford Hospital
Detroit
Spectrum Health
Grand Rapids
Minnesota
St. Cloud (CentraCare)
Saint Cloud
Montana
Providence St. Patrick
Missoula
New Jersey
Hackensack University Medical Ctr
Hackensack
Morristown Medical Center
Morristown
The Valley Hospital
Ridgewood
New Mexico
New Mexico Heart Institute
Albuquerque
New York
Buffalo General
Buffalo
CUMC/ New York Presbyterian Hospital
New York
Lenox Hill Hospital
New York
Oklahoma
Oklahoma Heart Hospital - South
Oklahoma City
Oregon
Providence St. Vincent Med Center
Portland
Tennessee
TriStar Centennial Medical Center
Nashville
Texas
Texas Health Presbyterian Hospital Dallas
Dallas
Baylor Scott & White The Heart Hospital Plano
Plano
Methodist Hospital - San Antonio
San Antonio
Virginia
Sentara Norfolk Health System
Norfolk
West Virginia
West Virginia University Hospital
Morgantown
Time Frame
Start Date: 2022-12-20
Completion Date: 2026-12-31
Participants
Target number of participants: 556
Treatments
Experimental: Impella ECP Device
Subjects receiving the Impella ECP.
Authors
Related Therapeutic Areas
Sponsors
Leads: Abiomed Inc.