Status:
ACTIVE_NOT_RECRUITING
Impella ECP Early Feasibility Study
Lead Sponsor:
Abiomed Inc.
Conditions:
High-risk Percutaneous Coronary Intervention
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneo...
Detailed Description
This is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary int...
Eligibility Criteria
Inclusion
- Age ≥ 18 years and ≤ 90 years
- Subject has signed the informed consent
- Scheduled for an elective or urgent high risk percutaneous coronary intervention with hemodynamic support
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 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 and has returned to his/her prior baseline (pre-COVID) clinical condition
- 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 \[Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention\]
Key Trial Info
Start Date :
October 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04477603
Start Date
October 9 2020
End Date
October 31 2026
Last Update
January 7 2026
Active Locations (5)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
2
Henry Ford Hospital
Detroit, Michigan, United States, 48202
3
Henry Ford Health St. John Hospital
Detroit, Michigan, United States, 48236
4
The Valley Hospital
Paramus, New Jersey, United States, 07652