High-Risk Percutaneous Coronary InterventionNCT05334784
Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol
A study testing Impella ECP in people with High-Risk Percutaneous Coronary Intervention, run by Abiomed Inc. at 32 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- High-Risk Percutaneous Coronary Intervention
- What is being tested?
- Impella ECP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 856 participants
- Where
- 32 sitesUnited States
- Study dates
- 20 Dec 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤90 years
- Subject signed the informed consent
- 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
Who cannot join
- 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, 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
Show all 17Show fewer
- 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
- Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥8 weeks
- Known contraindication to heparin (i.e., heparin-induced thrombocytopenia), contrast media or Study-required medication(s) (i.e., aspirin)
- Platelet count <75k, bleeding diathesis, coagulopathy or unwilling to receive blood transfusions
- Subject is on dialysis
- Suspected or known pregnancy
- 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
- 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
- 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
Trial locations and contacts
32 sites in 1 country. Contact the study team or a site near you to ask about taking part.
32 sites in 1 country
United States32 sites
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
Emory University Hospital
Atlanta, Georgia, 30322
Tufts Medical Center
Boston, Massachusetts, 02111
Manatee Memorial Hospital
Bradenton, Florida, 34208
Buffalo General
Buffalo, New York, 14203
Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231
Henry Ford Hospital
Detroit, Michigan, 48202
Ascension St. John Hospital
Detroit, Michigan, 48236
North Florida Regional Medical Center
Gainesville, Florida, 34208
Adventist Health Glendale
Glendale, California, 91206
Spectrum Health
Grand Rapids, Michigan, 49503
Hackensack University Medical Ctr
Hackensack, New Jersey, 07601
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Keck Hospital of USC
Los Angeles, California, 90033
Providence St. Patrick
Missoula, Montana, 59802
West Virginia University Hospital
Morgantown, West Virginia, 26506
Morristown Medical Center
Morristown, New Jersey, 07960
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
Ochsner Foundation Hospital
New Orleans, Louisiana, 70121
CUMC/ New York Presbyterian Hospital
New York, New York, 10032
Lenox Hill Hospital
New York, New York, 10075
Sentara Norfolk Health System
Norfolk, Virginia, 23507
Oklahoma Heart Hospital - South
Oklahoma City, Oklahoma, 73135
St. Joseph's Medical Center - Phoenix
Phoenix, Arizona, 85013
Baylor Scott & White The Heart Hospital Plano
Plano, Texas, 75093
Providence St. Vincent Med Center
Portland, Oregon, 97225
The Valley Hospital
Ridgewood, New Jersey, 07450
St. Cloud (CentraCare)
Saint Cloud, Minnesota, 56303
Methodist Hospital - San Antonio
San Antonio, Texas, 78229
Loma Linda University Medical Center
San Bernardino, California, 92354
AdventHealth - Tampa
Tampa, Florida, 33613
Pima Heart & Vascular
Tucson, Arizona, 85712
About this study
Official title: 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
Read the 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.
- Being tested
- Impella ECP
- Keywords
- HRPCI, High-risk percutaneous coronary intervention, Circulatory support, Left ventricular unloading, Abiomed, Impella, Impella ECP, Impella ECP CAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella ECPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Impella ECP Device | Experimental | Subjects receiving the Impella ECP. Receives: Device: Impella ECP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MACCE
The rate of major adverse cardiovascular and cerebrovascular events (MACCE)
Measured: Device Delivery through 30 Days
Impella ECP-related major vascular complications (Safety Endpoint 1)
Impella ECP-related major vascular complications
Measured: 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
Measured: Device Delivery through Discharge from the Index Hospital Admission (assessed up to 30 days)
Secondary outcomes (4)
Number of Subjects with Major Hemolysis
Measured: Device Delivery through Discharge (assessed up to 30 days)
Number of Subjects with Aortic Valve Injury
Measured: Device Delivery through Discharge (assessed up to 30 days)
Number of Subjects with Escalation of Care to Impella CP
Measured: Device Removal through Discharge (assessed up to 30 days)
Length of Hospital Stay for enrolled patients
Measured: Admission through Discharge (assessed up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start20 Dec 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Risk Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 856 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Navin Kapur, MD, Study director, Abiomed Inc.Seth Bilazarian, MD, Study director, Abiomed Inc.Amir Kaki, MD, Principal investigator, Ascension St. John Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334784
- Sponsor's protocol ID
- ABMD-CIP-22-01
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2022
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention Impella ECP Continued Access Protocol
- ClinicalTrials.gov ID
- NCT05334784
- Acronym / sponsor ID
- ABMD-CIP-22-01
- Keywords
- HRPCI, High-risk percutaneous coronary intervention, Circulatory support, Left ventricular unloading, Abiomed, Impella, Impella ECP, Impella ECP CAP
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 856 participants (estimated)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Impella ECP Device | Experimental | Device: Impella ECPSubjects receiving the Impella ECP. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years and ≤90 years
- Subject signed the informed consent
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impella ECPSubjects 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. | Device | Impella ECP Device |
Primary outcome
Rate of MACCE
Time frame: Device Delivery through 30 Days
The rate of major adverse cardiovascular and cerebrovascular events (MACCE)
Impella ECP-related major vascular complications (Safety Endpoint 1)
Time frame: 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)
Time frame: Device Delivery through Discharge from the Index Hospital Admission (assessed up to 30 days)
Impella ECP-related Major Bleeding
4 secondary outcomes
Number of Subjects with Major Hemolysis
Time frame: Device Delivery through Discharge (assessed up to 30 days)
Number of Subjects with Aortic Valve Injury
Time frame: Device Delivery through Discharge (assessed up to 30 days)
Number of Subjects with Escalation of Care to Impella CP
Time frame: Device Removal through Discharge (assessed up to 30 days)
Length of Hospital Stay for enrolled patients
Time frame: Admission through Discharge (assessed up to 30 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Navin Kapur, MD study director
Abiomed Inc.
Seth Bilazarian, MD study director
Abiomed Inc.
Amir Kaki, MD principal investigator
Ascension St. John Hospital
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impella ECP in people with High-Risk Percutaneous Coronary Intervention, run by Abiomed Inc. at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of MACCE (time frame: Device Delivery through 30 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.