Heart pump may boost survival in complex stenting

NCT ID NCT04763200

Disease control Sponsor: Abiomed Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study tests whether using the Impella heart pump during a high-risk stenting procedure helps people with weak hearts and blocked arteries. About 1,250 participants will be randomly assigned to get either Impella-supported stenting or standard care. The goal is to see if the device reduces death, stroke, heart attack, or the need for more procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,252 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years and ≤90 years 2. Clinical presentation and baseline left ventricular function are as follows: Either 2A or 2B must be present A. Subject has CCS or NSTEMI with an LVEF ≤40% NOTE: The LVEF must be quantitatively measured as ≤40% by echo within 30 days assuming no change in clinical condition. If multiple echos have been performed within 30-days, the most recent test must be used to qualify the patient. NOTE: Subject qualifies if the quantitative site read LVEF is ≤30%; if the quantitative site read is \>30% - ≤40% the Echo Core Lab must confirm the LVEF is ≤40% before subject enrollment (Core Lab will provide \<48-hour turnaround). Similarly, if the site read is qualitative only (i.e., only provides broad ranges without detailed LVEF quantification), the Echo Core Lab must confirm the LVEF is ≤40% before subject enrollment. OR B. Subject has STEMI ≥24 hours and \<30 days after symptom onset with an LVEF ≤30% NOTE: In patients qualifying with recent STEMI, the LVEF must be demonstrated to be ≤30% by quantitative echocardiography after the primary PCI procedure (if performed) and within 72-hours prior to the planned randomization. If primary PCI was not performed, the qualifying echocardiogram will be the one taken during the index hospitalization closest to the index procedure. If the site read is qualitative only (i.e., only provides broad ranges without detailed LVEF quantification), the Echo Core Lab must confirm the LVEF is ≤30% before subject enrollment. 3. Local heart team (interventional cardiologist and cardiac surgeon) has determined that PCI is indicated and is the most appropriate management for the patient 4. Complex PCI will be performed: Either 4A or 4B must be met A. One of the following must be present: i. Triple vessel disease is present (visually-assessed angiographic DS ≥80% \[or ≥40% if non-invasive evidence of ischemia on a localizing stress test or invasive evidence of ischemia (FFR ≤0.80 or iFR ≤0.89)\] is present in all 3 epicardial coronary artery distributions in a main vessel or branch with visually-assessed reference vessel diameter ≥2.5 mm) with PCI planned in ≥2 of these vessels in the proximal or mid LAD, proximal or mid-LCX or proximal, mid- or distal RCA \[i.e., not a branch vessel\]) OR ii. Left main distal bifurcation or trifurcation disease (visually-assessed DS ≥50% \[or DS ≥30% if non-invasive evidence of ischemia in both the anterior and posterolateral distributions or left main IVUS MLA ≤6.0 mm2 or FFR ≤0.80 or iFR ≤0.89\] is present) with planned intervention of the left main plus at least 2 branch vessels (i.e., the ostial LAD, ostial LCX or ostial ramus) OR iii. Left main equivalent disease with both ostial LAD and ostial LCX having visually-assessed angiographic DS ≥80% \[or ≥40% if non-invasive evidence of ischemia on a localizing stress test or invasive evidence of ischemia (FFR ≤0.80 or iFR ≤0.89\] and requiring intervention in both branches OR iv. Intervention of the last remaining vessel (native coronary artery or bypass graft) OR B. Multivessel disease is present (visually-assessed angiographic DS ≥80% \[or ≥40% if non-invasive or invasive evidence of ischemia is present\] in ≥2 of the 3 epicardial coronary artery distributions in a main vessel or branch with visually-assessed reference vessel diameter ≥2.5 mm) and PCI is planned of at least 2 separate complex lesions in main vessels or branch vessels each having one or more of the following characteristics: i. Long lesion (≥28 mm visually assessed) requiring ≥30 mm stent length (single or multiple) ii. Severe angiographic calcification (see Protocol definition) or requiring atheroablation iii. Any left main morphology not in Criterion A requiring intervention (e.g., isolated ostial or mid-shaft left main lesion or distal left main bifurcation lesion with a planned single provisional stent technique) iv. Non-left main bifurcation lesion requiring intervention in both the main branch and side branch v. CTO (TIMI 0 Flow) vi. Giant thrombus (length ≥3x vessel diameter) vii. SVG (other than focal (\<5 mm) disease of the proximal or distal anastomosis or in-stent restenosis) NOTES: 1. The multiple lesions can be in the same vessel if separated by ≥10 mm - however, each separate lesion has to have one or more of the above characteristics 2. PCI may be performed on additional non-qualifying lesions (i.e., without 1 or more of the above high-risk characteristics) as long as there are at least two lesions also undergoing PCI with each having 1 or more of the above characteristics) 3. There are 2 exceptions to the rule that each separate lesion must have one or more of the above characteristics (as in Inclusion Criterion 4B above): The subject may qualify if undergoing complex PCI of a single lesion that has 2 or more of the above complex characteristics (as in Inclusion Criterion 4B above) if also: i. There is a CTO of a proximal or mid-LAD, proximal or mid-LCX or proximal, mid- or distal RCA (i.e., not a branch vessel) that will not be treated OR ii. The subject qualifies with recent STEMI with an LVEF ≤30% and the complex PCI is planned in a non-infarct vessel (i.e., a complex PCI in the infarct vessel does not qualify) 5. Subject or legal guardian (permitted at US sites only) agrees to randomization and to follow all study procedures and provides informed, written consent Exclusion Criteria: Subjects must not meet ANY of the following Exclusion Criteria to participate in the Trial: 1. STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present (e.g., VSD, papillary muscle rupture, etc.) 2. Cardiogenic shock (SBP \<80 mmHg for ≥30 mins and not responsive to intravenous fluids or hemodynamic deterioration for any duration requiring pressors or mechanical circulatory support, including IABP) 3. Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for \>24 hours with full neurologic recovery) 4. Cardiorespiratory arrest related to the current admission unless subject is extubated for \>24 hours with full neurologic recovery and hemodynamically stable 5. Any contraindication or inability to Impella placement in both the left and right common femoral artery based on clinical or imaging findings, including iliofemoral artery diameter \<5 mm, tortuous vascular anatomy or severe bilateral peripheral vascular disease of the iliac or femoral arteries that can't be adequately treated (e.g., with intravascular lithotripsy) NOTES: 1. Computed tomography (CT), magnetic resonance angiography (MRA) or contrast angiography to assess the aorta and iliofemoral vasculature to ensure Impella compatibility must be performed within 90 days prior to randomization. It is recommended that this evaluation be performed prior to the index procedure. Absent a qualifying pre-procedure imaging study, contrast angiography of the potential Impella access vessel(s) must be performed in the Cath Lab before the planned enrollment after which the subject may be randomized if he/she still qualifies. Of note, if pre-procedure imaging was performed and after this test but before randomization there was a worsening in PVD symptoms, repeat imaging must be performed prior to randomization. 2. If iliofemoral peripheral vascular disease is present precluding Impella use that can be adequately treated with angioplasty, atherectomy or lithotripsy (without a stent), the subject can be enrolled if such treatment is undertaken and is successful and uncomplicated - randomization must not be performed until such successful and uncomplicated treatment 6. Iliofemoral stents placed within 6 months of enrollment with planned vascular access through these vascular segments 7. Vascular access for Impella is required in any location other than the left or right common femoral artery (i.e., axillary access, transcaval access, etc., for Impella access are not permitted) 8. Known left ventricular thrombus 9. Incessant ventricular arrhythmias that would likely preclude stable Impella positioning 10. Severe aortic stenosis or severe aortic insufficiency 11. Prior mechanical valve or self-expanding TAVR (NOTE: prior bioprosthetic surgical valve or balloon expandable TAVR implanted \>24 hours pre-procedure is acceptable) 12. Prior CABG within three (3) months or successful prior PCI of at least one (1) attempted lesion within 12 months (including during the index hospitalization prior to randomization), that has not experienced stent thrombosis or restenosis during that 12-month period; the one (1) exception is that patients may be enrolled if a primary PCI for STEMI was performed during the index hospitalization without MCS and that was ≥24 hours and \<30 days prior to randomization. NOTE: Successful PCI for this exclusion criterion is defined as a visually-assessed angiographic DS ≤50% in at least one (1) attempted lesion. 13. Prior placement of IABP, Impella or any other MCS device for any reason during the index admission, prior to randomization 14. Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization) \>70 mm Hg unless active vasodilator therapy in the Cath Lab is able to reduce the pulmonary vascular resistance (PVR) to \<3 Wood Units or between 3 and 4.5 Wood Units with v-wave less than twice the mean of the pulmonary capillary wedge pressure 15. Symptoms or signs of severe RV dysfunction, such as anasarca (NOTE: Leg edema alone does not necessarily indicate severe RV dysfunction if the investigator believes it is due to LV dysfunction) 16. Severe tricuspid insufficiency 17. Platelet count \<75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwilling to receive blood transfusions 18. On dialysis 19. Prior stroke with any permanent neurologic deficit within the previous three (3) months, 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 20. Taking a chronic oral anticoagulant that cannot be safely discontinued for at least 72-hours before and 72-hours after the index procedure (if a vitamin K antagonist) or that cannot be safely discontinued for at least 48 hours before and 48 hours after the index procedure (for a direct acting oral anticoagulant) 21. Plan for any surgery within 6 months necessitating discontinuing antiplatelet agents 22. Pregnant or child-bearing potential unless negative pregnancy test within 1 week 23. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint 24. Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits 25. Any non-cardiac condition with life expectancy \<3 years (e.g., cirrhosis, oxygen or oral steroid dependent COPD, cancer not in remission, etc.) 26. Subject is currently hospitalized for definite or suspected COVID-19 27. Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥4 weeks and has returned to his/her prior baseline (pre-COVID) clinical condition 28. Subject is asymptomatic (never ill) and COVID-19 PCR/antigen test is positive within the prior four (4) weeks unless a) subject remains asymptomatic for ≥2 weeks after the last positive test or b) the positive test occurred within six (6) months after the subject received a COVID vaccine 29. Subject belongs to a vulnerable population (defined as individuals with mental disability, 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)

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Conditions

The condition(s) this trial relates to.

anterolateral myocardial infarction cardiovascular disorder coronary artery disorder heart disorder inferior myocardial infarction left ventricular failure myocardial infarction myocardial ischemia Non-ST Elevated Myocardial Infarction Ventricular Dysfunction, Left

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease Left ventricular dysfunction

Contacts and locations

Locations

Adventist Health Glendale

Glendale, California, 91206, United States
Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States
Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States
Arkansas Cardiology

Little Rock, Arkansas, 72205, United States
Ascension St. Thomas West

Nashville, Tennessee, 37205, United States
Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Baylor Scott & White Heart - Plano

Plano, Texas, 75093, United States
Berlin CBF

Berlin, 12203, Germany
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
CVK Berlin

Berlin, 13353, Germany
Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States
Carilion Clinic

Roanoke, Virginia, 24014, United States
Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands
Catholic Medical Center

Manchester, New Hampshire, 03102, United States
Centennial Heart - Nashville

Nashville, Tennessee, 37203, United States
CentraCare (St. Cloud Hospital)

Saint Cloud, Minnesota, 56303, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Colorado Heart and Vascular

Lakewood, Colorado, 80228, United States
Columbia University Medical Cenrer/NYPH

New York, New York, 10032, United States
Corewell Health

Grand Rapids, Michigan, 49435, United States
Duke University

Durham, North Carolina, 27710, United States
Emory University Hospital

Atlanta, Georgia, 30322, United States
Englewood Hospital

Englewood, New Jersey, 07631, United States
Greenville Hospital System

Greenville, South Carolina, 29605, United States
HCA Houston Healthcare

Houston, Texas, 77004, United States
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Hartford Hospital

Hartford, Connecticut, 06106, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Henry Ford St. John Hospital

Detroit, Michigan, 48236, United States
Herzzentrum Dresden GmbH

Dresden, 01307, Germany
Houston Methodist Hospital

Houston, Texas, 77030, United States
Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States
Inselspital Bern

Bern, 3010, Switzerland
Istituto Cardiocentro Ticino

Lugano, Canton Ticino, 6900, Switzerland
Jersey Shore University Medical Center

Neptune City, New Jersey, 07735, United States
Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany
Klinikum Friedrichshafen GmbH

Friedrichshafen, 88048, Germany
Klinikum Karlsburg

Karlsburg, Mecklenburg-Vorpommern, 17495, Germany
Klinikum rechts der Isar der TUM

Munich, Bavaria, 81675, Germany
Krankenhaus der Barmherzigen Brüder

Trier, Rhineland-Palatinate, 54292, Germany
Legacy Emanuel Hospital & Health Center

Portland, Oregon, 97232, United States
Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States
Linder Research Center (The Christ Hospital)

Cincinnati, Ohio, 45219, United States
Loma Linda University Health

San Bernardino, California, 92354, United States
Lovelace/New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States
Luzerner Kantonsspital

Lucerne, 6000, Switzerland
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Medical City Fort Worth

Fort Worth, Texas, 76104, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Memorial Hermann Texas Medical Center (UT Health)

Houston, Texas, 77030, United States
Methodist Hospital - San Antonio

San Antonio, Texas, 78229, United States
Metropolitan Heart and Vascular Institute / Metropolitan Cardiology Consultants

Coon Rapids, Minnesota, 55433, United States
Montefiore Medical Center - Moses

The Bronx, New York, 10467-2401, United States
Monument Health Clinical Research

Rapid City, South Dakota, 57701, United States
Morristown Medical Center

Morristown, New Jersey, 07960, United States
NYU Langone Health

New York, New York, 10016, United States
North Carolina Heart and Vascular Research

Raleigh, North Carolina, 27607, United States
NorthShore University Health System

Evanston, Illinois, 60201, United States
Northside Cardiovascular Institute

Lawrenceville, Georgia, 30043, United States
Northwell University Hospital

Manhasset, New York, 11030, United States
Northwest Medical Center Tucson

Tucson, Arizona, 85741, United States
Northwestern University

Evanston, Illinois, 60208, United States
Norton Healthcare - Norton Heart Specialists

Louisville, Kentucky, 40205, United States
Ochsner Foundation Hospital

New Orleans, Louisiana, 70121, United States
Ospedale di San Donato

San Donato Milanese, Italy
Parkwest Medical Center

Knoxville, Tennessee, 37923, United States
Policlinico Universitario Agostino Gemelli

Rome, RM, 00168, Italy
Presbyterian Hospital Dallas / Texas Health Physicians Group

Dallas, Texas, 75231, United States
Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States
Royal Brompton Hospital

London, United Kingdom
Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada
Rush University Medical Center

Chicago, Illinois, 60612, United States
SSM Health DePaul Hospital

Bridgeton, Missouri, 63044, United States
Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States
Sentara Norfolk Health System

Norfolk, Virginia, 23507, United States
St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada
St. Francis Hospital and Heart Center

Roslyn, New York, 11576, United States
St. Joseph Hospital - Orange

Orange, California, 92868, United States
St. Joseph's Medical Center - Phoenix

Phoenix, Arizona, 85016, United States
St. Luke's Hospital

Kansas City, Missouri, 64111, United States
St. Vinzenz-Hospital GMBH KÖLN

Cologne, 50733, Germany
Stony Brook University Hospital (SUNY)

Stony Brook, New York, 11794, United States
Texas Cardiology Associates of Houston

Kingwood, Texas, 77339, United States
Texas Heart Institute at Baylor St. Luke's Hospital

Houston, Texas, 77030, United States
The Cardiac & Vascular Institute

Gainesville, Florida, 32605, United States
The Valley Hospital - Ridgewood

Ridgewood, New Jersey, 07450, United States
Toronto General Hospital

Toronto, Ontario, Canada
Tufts Medical Center

Boston, Massachusetts, 02111, United States
UCSD Medical Center

San Diego, California, 92093, United States
UF Health Jacksonville

Jacksonville, Florida, 32209, United States
Uniklinik Würzburg

Würzburg, 97080, Germany
University Hopsital Frankfurt

Frankfurt, Germany
University Hospital Aachen

Aachen, 52074, Germany
University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States
University Of Washington Medical Center

Seattle, Washington, 98195, United States
University at Buffalo/Kaleida Health

Buffalo, New York, 14203, United States
University of Alabama

Birmingham, Alabama, 35294, United States
University of Florida Health - Gainesville

Gainesville, Florida, 32610, United States
University of Oklahoma Medical Center

Oklahoma City, Oklahoma, 73104, United States
Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany
Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany
Universitätsklinikum Essen AöR

Essen, 45147, Germany
Universitätsklinikum Freiburg, Universitäts-Herzzentrum

Bad Krozingen, 79189, Germany
Universitätsklinikum Gießen

Giessen, 35392, Germany
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
WellSpan York Hospital

York, Pennsylvania, 17403, United States
Wellmont Cardiology Services

Kingsport, Tennessee, 37660, United States
West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

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