Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention Impella ECP Continued Access Protocol
Overview
- Phase
- Not Applicable
- Intervention
- Impella ECP
- Conditions
- High-Risk Percutaneous Coronary Intervention
- Sponsor
- Abiomed Inc.
- Enrollment
- 856
- Locations
- 32
- Primary Endpoint
- Rate of MACCE
- Status
- Enrolling By Invitation
- Last Updated
- last month
Overview
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 patients undergoing elective or urgent high-risk percutaneous coronary intervention.
The above applies to Impella ECP Continued Access Protocol
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 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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
Impella ECP Device
Subjects receiving the Impella ECP.
Intervention: Impella ECP
Outcomes
Primary Outcomes
Rate of MACCE
Time Frame: Device Delivery through 30 Days
The rate of major adverse cardiovascular and cerebrovascular events (MACCE)
Impella ECP-related Major Bleeding (Safety Endpoint 2)
Time Frame: Device Delivery through Discharge from the Index Hospital Admission (assessed up to 30 days)
Impella ECP-related Major Bleeding
Impella ECP-related major vascular complications (Safety Endpoint 1)
Time Frame: From the Date of Device Delivery through Date of Discharge (assessed up to 30 days)
Impella ECP-related major vascular complications
Secondary Outcomes
- Number of Subjects with Escalation of Care to Impella CP(Device Removal through Discharge (assessed up to 30 days))
- Number of Subjects with Major Hemolysis(Device Delivery through Discharge (assessed up to 30 days))
- Number of Subjects with Aortic Valve Injury(Device Delivery through Discharge (assessed up to 30 days))
- Length of Hospital Stay for enrolled patients(Admission through Discharge (assessed up to 30 days))