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NCT05334784

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

Enrolling by Invitation
NAAges 18–90InterventionalTreatment
Abiomed Inc.
~856 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Impella ECP

At a glance

Recruiting sites
0 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of MACCE
Measured over Device Delivery through 30 Days
+2 more outcomes measured

Conditions

High-Risk Percutaneous Coronary Intervention

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Percutaneous Coronary Intervention

Where it's being run

32 sites across 19 states
California3
Florida3
Michigan3
New Jersey3
New York3
Texas3
Arizona2
Arkansas1

Study leadership

  • Navin Kapur, MD · STUDY_DIRECTOR · Abiomed Inc.
  • Seth Bilazarian, MD · STUDY_DIRECTOR · Abiomed Inc.
  • Amir Kaki, MD · PRINCIPAL_INVESTIGATOR · Ascension St. John Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Rate of MACCEDevice Delivery through 30 Days

    The rate of major adverse cardiovascular and cerebrovascular events (MACCE)

  • Impella ECP-related major vascular complications (Safety Endpoint 1)From the Date of Device Delivery through Date of Discharge (assessed up to 30 days)

    Impella ECP-related major vascular complications

  • Impella ECP-related Major Bleeding (Safety Endpoint 2)Device Delivery through Discharge from the Index Hospital Admission (assessed up to 30 days)

    Impella ECP-related Major Bleeding