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

High-Risk Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05334784
• Other study ID #: ABMD-CIP-22-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: December 2023
• Source: Abiomed Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 556
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• High-Risk Percutaneous Coronary Intervention

Intervention

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.

Locations

Country	Name	City	State
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	Emory University Hospital	Atlanta	Georgia
United States	Tufts Medical Center	Boston	Massachusetts
United States	Manatee Memorial Hospital	Bradenton	Florida
United States	Buffalo General	Buffalo	New York
United States	Texas Health Presbyterian Hospital Dallas	Dallas	Texas
United States	Ascension St. John Hospital	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	North Florida Regional Medical Center	Gainesville	Florida
United States	Adventist Health Glendale	Glendale	California
United States	Spectrum Health	Grand Rapids	Michigan
United States	Hackensack University Medical Ctr	Hackensack	New Jersey
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Keck Hospital of USC	Los Angeles	California
United States	Providence St. Patrick	Missoula	Montana
United States	West Virginia University Hospital	Morgantown	West Virginia
United States	Morristown Medical Center	Morristown	New Jersey
United States	TriStar Centennial Medical Center	Nashville	Tennessee
United States	Ochsner Foundation Hospital	New Orleans	Louisiana
United States	Lenox Hill Hospital	New York	New York
United States	New York Presbyterian (CUMC)	New York	New York
United States	Sentara Norfolk Health System	Norfolk	Virginia
United States	Oklahoma Heart Hospital - South	Oklahoma City	Oklahoma
United States	St. Joseph's Medical Center - Phoenix	Phoenix	Arizona
United States	Baylor Scott & White The Heart Hospital Plano	Plano	Texas
United States	Providence St. Vincent Med Center	Portland	Oregon
United States	The Valley Hospital	Ridgewood	New Jersey
United States	St. Cloud (CentraCare)	Saint Cloud	Minnesota
United States	Methodist Hospital - San Antonio	San Antonio	Texas
United States	Loma Linda University Medical Center	San Bernardino	California
United States	AdventHealth - Tampa	Tampa	Florida
United States	Tucson Medical Center/ PIMA Heart & Vascular	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of MACCE	The rate of major adverse cardiovascular and cerebrovascular events (MACCE)	Device Delivery through 30 Days
Primary	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)
Primary	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	Number of Subjects with Major Hemolysis		Device Delivery through Discharge (assessed up to 30 days)
Secondary	Number of Subjects with Aortic Valve Injury		Device Delivery through Discharge (assessed up to 30 days)
Secondary	Number of Subjects with Escalation of Care to Impella CP		Device Removal through Discharge (assessed up to 30 days)
Secondary	Length of Hospital Stay for enrolled patients		Admission through Discharge (assessed up to 30 days)