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

Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention Impella ECP Continued Access Protocol

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

Study Overview

• Status: Enrolling by invitation
• Conditions: High-Risk Percutaneous Coronary Intervention
• Intervention / Treatment: Device: Impella ECP

Detailed Description

This is a prospective, multi-center, single-arm study evaluating the major adverse cardiovascular and cerebrovascular event (MACCE) rate of the Impella ECP device in adult patients undergoing elective or urgent high-risk percutaneous coronary intervention (HRPCI). Additionally, this study will evaluate safety related to Impella ECP-related major vascular complications and Impella ECP-related major bleeding. Finally, this study will evaluate secondary endpoints including the occurrence of major hemolysis, aortic valve injury, escalation of care to Impella CP, and the length of hospital stay.

Investigational device products include: Impella ECP pump system (a percutaneous transvalvular micro-axial blood pump), 9Fr introducer sheath, and the automated Impella controller (AIC) with revised console software to allow control of the Impella ECP.

Study flow: Following informed consent, subjects eligible for a HRPCI that meet all of the inclusion and none of the exclusion criteria will be enrolled into the Study. Subjects will undergo Impella ECP placement through a femoral sheath, following crimping of the Impella ECP. The intended coronary intervention will be performed with the mechanical circulatory support provided by the Impella ECP. Once the procedure is completed, the device is weaned and removed. Subjects will be followed for 30 days. Subjects will be treated based on the contemporary AHA/ACC/SCAI practice guidelines throughout the duration of the Study.

A sample size of two hundred seventeen (217) subjects with 30-day follow-up is needed for 90% power at a one-sided 0.05 significance level. Assuming 15% loss-to-follow-up, up to two hundred fifty-six (256) subjects will be enrolled. Safety endpoints will be presented as summary statistics without formal hypothesis testing. The MACCE rate will be assessed against the PG of 24.4% at one-sided 5% significance level.

Impella ECP Continued Access Protocol:

Description, Investigational device and study flow remains the same as above.

A sample size up to three hundred (300) subjects will be enrolled at up to 25 sites. Sites must have been activated in the Pivotal to be eligible for the Continued Access Protocol.

• Study Type: Interventional
• Enrollment (Estimated): 556
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Viktoria Bulkley, BSN; Phone Number: 859-270-9920; Email: vbulkley@abiomed.com
• Study Contact Backup: Name: Rachel Bostonian; Phone Number: 978-882-8229; Email: rbostonian@abiomed.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Medical Center - Phoenix
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center/ PIMA Heart & Vascular
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • Glendale, California, United States, 91206
      • Adventist Health Glendale
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC
    • San Bernardino, California, United States, 92354
      • Loma Linda University Medical Center
  • Florida
    • Bradenton, Florida, United States, 34208
      • Manatee Memorial Hospital
    • Gainesville, Florida, United States, 34208
      • North Florida Regional Medical Center
    • Tampa, Florida, United States, 33613
      • AdventHealth - Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Foundation Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48236
      • Ascension St. John Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health
  • Minnesota
    • Saint Cloud, Minnesota, United States, 56303
      • St. Cloud (CentraCare)
  • Montana
    • Missoula, Montana, United States, 59802
      • Providence St. Patrick
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Ctr
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
  • New York
    • Buffalo, New York, United States, 14203
      • Buffalo General
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • New York, New York, United States, 10032
      • New York Presbyterian (CUMC)
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
      • Oklahoma Heart Hospital - South
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Med Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • TriStar Centennial Medical center
  • Texas
    • Dallas, Texas, United States, 75231
      • Texas Health Presbyterian Hospital Dallas
    • Plano, Texas, United States, 75093
      • Baylor Scott & White The Heart Hospital Plano
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital - San Antonio
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk Health System
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years and ≤90 years
2. Subject signed the informed consent
3. Subject is hemodynamically stable and a heart team, including a cardiac surgeon, has determined that an elective or urgent (not emergent) high-risk PCI is the appropriate therapeutic option

Exclusion Criteria:

1. Aortic valve disease that is anticipated to be prohibitive to Impella ECP crossing, including greater than mild aortic stenosis
2. Previous aortic valve replacement or reconstruction
3. Thrombus in left ventricle
4. Subjects with known aortic vessel disease or with aortic dissection
5. Any contraindication that precludes placing an Impella including aortic, iliac or femoral disease such as tortuosity, extensive atherosclerotic disease or stenosis
6. Prior stroke with any permanent, significant (mRS>2), 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
7. 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
8. Infection of the proposed procedural access site or suspected systemic active infection, including any fever
9. Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥8 weeks
10. Known contraindication to heparin (i.e., heparin-induced thrombocytopenia), contrast media or Study-required medication(s) (i.e., aspirin)
11. Platelet count <75k, bleeding diathesis, coagulopathy or unwilling to receive blood transfusions
12. Subject is on dialysis
13. Suspected or known pregnancy
14. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures
15. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary endpoint
16. Subject belongs to a vulnerable population [Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention]

The above Inclusion/Exclusion criteria applies for Impella ECP Continued Access Protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Impella ECP Device; Subjects receiving the Impella ECP.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of MACCE	The rate of major adverse cardiovascular and cerebrovascular events (MACCE)	Device Delivery through 30 Days
Impella ECP-related major vascular complications (Safety Endpoint 1)	Impella ECP-related major vascular complications	From the Date of Device Delivery through Date of Discharge (assessed up to 30 days)
Impella ECP-related Major Bleeding (Safety Endpoint 2)	Impella ECP-related Major Bleeding	Device Delivery through Discharge from the Index Hospital Admission (assessed up to 30 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Subjects with Major Hemolysis	Device Delivery through Discharge (assessed up to 30 days)
Number of Subjects with Aortic Valve Injury	Device Delivery through Discharge (assessed up to 30 days)
Number of Subjects with Escalation of Care to Impella CP	Device Removal through Discharge (assessed up to 30 days)
Length of Hospital Stay for enrolled patients	Admission through Discharge (assessed up to 30 days)

Collaborators and Investigators

• Sponsor: Abiomed Inc.
• Investigators: Study Director: Chuck Simonton, MD, Abiomed Inc.; Study Director: Seth Bilazarian, MD, Abiomed Inc.; Principal Investigator: Amir Kaki, MD, Ascension St. John Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Impella; HRPCI; High-risk percutaneous coronary intervention; Abiomed; Impella ECP; Circulatory support; Left ventricular unloading; Impella ECP CAP
• Other Study ID Numbers: ABMD-CIP-22-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes