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

Conditions

• High-Risk Percutaneous Coronary Intervention

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Impella ECP — DEVICE
  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.

Study Details

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

Key Dates

Start date

Dec 20, 2022

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

856 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Impella ECP Device
  Subjects receiving the Impella ECP.

Primary Outcome Measure

Rate of MACCE [ Time Frame: Device Delivery through 30 Days ]

Locations (32)

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