Abiomed Inc.
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
This is a prospective, multi-center, single-arm study evaluating the major adverse cardiovascular and cerebrovascular event (MACCE) rate of the Impella ECP device in adult patients undergoing elective or urgent high-risk percutaneous coronary intervention (HRPCI). Additionally, this study will evaluate safety related to Impella ECP-related major vascular complications and Impella ECP-related major bleeding. Finally, this study will evaluate secondary endpoints including the occurrence of major hemolysis, aortic valve injury, escalation of care to Impella CP, and the length of hospital stay. I…
Inclusion Criteria: 1. Age ≥18 years and ≤90 years 2. Subject signed the informed consent 3. 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 Exclusion Criteria: 1. Aortic valve disease that is anticipated to be prohibitive to Impella ECP crossing, including greater than mild aortic stenosis 2. Previous aortic valve replacement or reconstruction 3. Thrombus in left ventricle 4. Subjects with known aortic vessel disease or with aortic dissection 5. Any…
Subjects will receive the Impella ECP prior to high-risk percutaneous intervention. Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be followed until 30-days post-intervention.