Impella ECP Study (ECP Study) and 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.

Investigational device products include: Impella ECP pump system (a percutaneous transvalvular micro-axial blood pump), 9Fr introducer sheath, and the automated Impella controller (AIC) with revised console software to allow control of the Impella ECP.

Study flow: Following informed consent, subjects eligible for a HRPCI that meet all of the inclusion and none of the exclusion criteria will be enrolled into the Study. Subjects will undergo Impella ECP placement through a femoral sheath, following crimping of the Impella ECP. The intended coronary intervention will be performed with the mechanical circulatory support provided by the Impella ECP. Once the procedure is completed, the device is weaned and removed. Subjects will be followed for 30 days. Subjects will be treated based on the contemporary AHA/ACC/SCAI practice guidelines throughout the duration of the Study.

A sample size of two hundred seventeen (217) subjects with 30-day follow-up is needed for 90% power at a one-sided 0.05 significance level. Assuming 15% loss-to-follow-up, up to two hundred fifty-six (256) subjects will be enrolled. Safety endpoints will be presented as summary statistics without formal hypothesis testing. The MACCE rate will be assessed against the PG of 24.4% at one-sided 5% significance level.

Impella ECP Continued Access Protocol:

Description, Investigational device and study flow remains the same as above.

A sample size up to six hundred (600) subjects will be enrolled at up to 25 sites. Sites must have been activated in the Pivotal to be eligible for the Continued Access Protocol.

Inclusion criteria

• 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

Exclusion criteria

• Aortic valve disease that is anticipated to be prohibitive to Impella ECP crossing, including greater than mild aortic stenosis
• Previous aortic valve replacement or reconstruction
• Thrombus in left ventricle
• Subjects with known aortic vessel disease or with aortic dissection
• Any contraindication that precludes placing an Impella including aortic, iliac or femoral disease such as tortuosity, extensive atherosclerotic disease or stenosis
• Prior stroke with any permanent, significant (mRS>2), neurologic deficit or any prior intracranial hemorrhage or any prior subdural hematoma or known intracranial pathology pre-disposing to intracranial bleeding, such as an arteriovenous malformation or mass
• Cardiogenic shock or acutely decompensated pre-existing chronic heart failure. Cardiogenic shock is defined as: systemic hypotension (systolic BP <90 mmHg or the need for inotropes/pressors to maintain a systolic BP >90 mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion or use of IABP or any other circulatory support device
• Infection of the proposed procedural access site or suspected systemic active infection, including any fever
• Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥8 weeks
• Known contraindication to heparin (i.e., heparin-induced thrombocytopenia), contrast media or Study-required medication(s) (i.e., aspirin)
• Platelet count <75k, bleeding diathesis, coagulopathy or unwilling to receive blood transfusions
• Subject is on dialysis
• Suspected or known pregnancy
• Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures
• Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary endpoint
• Subject belongs to a vulnerable population [Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention]

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