Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol

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, hasdetermined that an elective or urgent (not emergent) high-risk PCI is theappropriate 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 contraindication that precludes placing an Impella including aortic, iliac orfemoral disease such as tortuosity, extensive atherosclerotic disease or stenosis

6. Prior stroke with any permanent, significant (mRS>2), neurologic deficit or anyprior intracranial hemorrhage or any prior subdural hematoma or known intracranialpathology pre-disposing to intracranial bleeding, such as an arteriovenousmalformation or mass

7. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.Cardiogenic shock is defined as: systemic hypotension (systolic BP <90 mmHg or theneed for inotropes/pressors to maintain a systolic BP >90 mmHg) plus one of thefollowing: any requirement for pressors/inotropes prior to arrival at thecatheterization laboratory, clinical evidence of end-organ hypoperfusion or use ofIABP or any other circulatory support device

8. Infection of the proposed procedural access site or suspected systemic activeinfection, including any fever

9. Subject has previously been symptomatic with or hospitalized for COVID-19 unlesshe/she has been discharged (if hospitalized) and asymptomatic for ≥8 weeks

10. Known contraindication to heparin (i.e., heparin-induced thrombocytopenia), contrastmedia or Study-required medication(s) (i.e., aspirin)

11. Platelet count <75k, bleeding diathesis, coagulopathy or unwilling to receive bloodtransfusions

12. Subject is on dialysis

13. Suspected or known pregnancy

14. Subject has other medical, social or psychological problems that, in the opinion ofthe Investigator, compromises the subject's ability to give written informed consentand/or to comply with study procedures

15. Participation in the active treatment or follow-up phase of another clinical studyof an investigational drug or device which has not reached its primary endpoint

16. Subject belongs to a vulnerable population [Vulnerable subject populations aredefined as individuals with mental disability, persons in nursing homes, children,impoverished persons, homeless persons, nomads, refugees and those permanentlyincapable of giving informed consent. Vulnerable populations also may includemembers of a group with a hierarchical structure such as university students,subordinate hospital and laboratory personnel, employees of the Sponsor, members ofthe armed forces and persons kept in detention]

The above Inclusion/Exclusion criteria applies for Impella ECP Continued Access Protocol