Clinical Trial

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

Enrolling by Invitation
View on ClinicalTrials.gov →
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
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2022-04-12; most recent amendment 2026-03-04.
Status change: Recruiting → Enrolling by Invitation 2023-12-08
Status change: Not Yet Recruiting → Recruiting 2022-12-23
Trial Details
NCT Number NCT05334784
Lead Sponsor Abiomed Inc.
Conditions High-Risk Percutaneous Coronary Intervention
Enrollment 856 participants
Start Date 2022-12-20
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-05