Clinical trial NCT05334784: Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol
Official title: Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention Impella ECP Continued Access Protocol
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: High-Risk Percutaneous Coronary Intervention
Keywords: HRPCI
High-risk percutaneous coronary intervention
Circulatory support
Left ventricular unloading
Abiomed
Impella
Impella ECP
Impella ECP CAP
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-19
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Upon completion of enrollment in the pivotal study, enrollment in Continued Access Protocol will begin.

ECP Pivotal enrolled 256 subjects and Impella ECP Continued Access Protocol anticipates to enroll up to 600 subjects
Primary purpose: TREATMENT

Brief summary: 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

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 six hundred (600) 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of MACCE
timeFrame: Device Delivery through 30 Days
measure: Impella ECP-related major vascular complications (Safety Endpoint 1)
timeFrame: From the Date of Device Delivery through Date of Discharge (assessed up to 30 days)
measure: Impella ECP-related Major Bleeding (Safety Endpoint 2)
timeFrame: Device Delivery through Discharge from the Index Hospital Admission (assessed up to 30 days)
Secondary outcomes:
measure: Number of Subjects with Major Hemolysis
timeFrame: Device Delivery through Discharge (assessed up to 30 days)
measure: Number of Subjects with Aortic Valve Injury
timeFrame: Device Delivery through Discharge (assessed up to 30 days)
measure: Number of Subjects with Escalation of Care to Impella CP
timeFrame: Device Removal through Discharge (assessed up to 30 days)
measure: Length of Hospital Stay for enrolled patients
timeFrame: Admission through Discharge (assessed up to 30 days)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Medical Center - Phoenix
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center/ PIMA Heart & Vascular
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Glendale
country: United States
facility: Adventist Health Glendale
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: San Bernardino
country: United States
facility: Loma Linda University Medical Center
state: California
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Tampa
country: United States
facility: AdventHealth - Tampa
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Foundation Hospital
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Saint Cloud
country: United States
facility: St. Cloud (CentraCare)
state: Minnesota
city: Missoula
country: United States
facility: Providence St. Patrick
state: Montana
city: Hackensack
country: United States
facility: Hackensack University Medical Ctr
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: Buffalo
country: United States
facility: Buffalo General
state: New York
city: New York
country: United States
facility: CUMC/ New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital - South
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Med Center
state: Oregon
city: Nashville
country: United States
facility: TriStar Centennial Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Health Presbyterian Hospital Dallas
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White The Heart Hospital Plano
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital - San Antonio
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk Health System
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
affiliation: Abiomed Inc.
name: Chuck Simonton, MD
role: STUDY_DIRECTOR
affiliation: Abiomed Inc.
name: Seth Bilazarian, MD
role: STUDY_DIRECTOR
affiliation: Ascension St. John Hospital
name: Amir Kaki, MD
role: PRINCIPAL_INVESTIGATOR
References: