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

Enrolling by invitation · Not applicable

Conditions studied: High-Risk Percutaneous Coronary Intervention

In brief

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

Key facts

Study ID

NCT05334784

Run by

Abiomed Inc.

People needed

856

Starts

2022-12-20

Expected to finish

2026-12-31

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Joseph's Medical Center - Phoenix — Phoenix, Arizona, United States
• Pima Heart & Vascular — Tucson, Arizona, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Adventist Health Glendale — Glendale, California, United States
• Keck Hospital of USC — Los Angeles, California, United States
• Loma Linda University Medical Center — San Bernardino, California, United States
• Manatee Memorial Hospital — Bradenton, Florida, United States
• North Florida Regional Medical Center — Gainesville, Florida, United States
• AdventHealth - Tampa — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Ochsner Foundation Hospital — New Orleans, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Ascension St. John Hospital — Detroit, Michigan, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• St. Cloud (CentraCare) — Saint Cloud, Minnesota, United States
• Providence St. Patrick — Missoula, Montana, United States
• Hackensack University Medical Ctr — Hackensack, New Jersey, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• New Mexico Heart Institute — Albuquerque, New Mexico, United States
• Buffalo General — Buffalo, New York, United States
• CUMC/ New York Presbyterian Hospital — New York, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• Oklahoma Heart Hospital - South — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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