Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol (NCT05334784) | Clinical Trial Compass
By InvitationNot Applicable
Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol
United States856 participantsStarted 2022-12-20
Plain-language 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
Who can participate
Age range18 Years – 90 Years
SexALL
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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
What they're measuring
1
Rate of MACCE
Timeframe: Device Delivery through 30 Days
2
Impella ECP-related major vascular complications (Safety Endpoint 1)
Timeframe: From the Date of Device Delivery through Date of Discharge (assessed up to 30 days)
3
Impella ECP-related Major Bleeding (Safety Endpoint 2)
Timeframe: Device Delivery through Discharge from the Index Hospital Admission (assessed up to 30 days)