Active — Not RecruitingNot Applicable

Impella ECP Early Feasibility Study

United States100 participantsStarted 2020-10-09

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years and ≤ 90 years
✓. Subject has signed the informed consent
✓. Scheduled for an elective or urgent high risk percutaneous coronary intervention with hemodynamic support

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 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
✕. Infection of the proposed procedural access site or suspected systemic active infection, including any fever

What they're measuring

Feasibility: successful hemodynamic support

Timeframe: through end of procedure, 1 day

Safety: Major Device-Related Adverse Events

Timeframe: through end of procedure, 1 day

Trial details

NCT IDNCT04477603

SponsorAbiomed Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-31

View on ClinicalTrials.gov More High-risk Percutaneous Coronary Intervention trials