NCT05334784

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

Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention Impella ECP Continued Access Protocol

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 856 (estimated)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High-Risk Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DEVICE	Impella ECP	Subjects will receive the Impella ECP prior to high-risk percutaneous intervention. Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be followed until 30-days post-intervention.

Timeline

• Start date: 2022-12-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-04-19
• Last updated: 2026-03-05

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated device study