Status:
ENROLLING_BY_INVITATION
Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol
Lead Sponsor:
Abiomed Inc.
Conditions:
High-Risk Percutaneous Coronary Intervention
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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 patie...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
856 Patients enrolled
Trial Details
Trial ID
NCT05334784
Start Date
December 20 2022
End Date
December 31 2026
Last Update
September 18 2025
Active Locations (32)
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1
St. Joseph's Medical Center - Phoenix
Phoenix, Arizona, United States, 85013
2
Pima Heart & Vascular
Tucson, Arizona, United States, 85712
3
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
4
Adventist Health Glendale
Glendale, California, United States, 91206