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Impella ECP Early Feasibility Study

NCT04477603 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-14

No results posted yet for this study

Summary

The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary intervention.

Conditions

  • High-risk Percutaneous Coronary Intervention

Interventions

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.

Sponsors & Collaborators

  • Abiomed Inc.

    lead INDUSTRY

Principal Investigators

  • Amir Kaki, MD · Ascension St. John Hospital

  • Seth Bilazarian, MD · Abiomed Inc.

  • Navin Kapur, MD · Abiomed Inc.

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-09
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04477603 on ClinicalTrials.gov