Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
PROTECT IV
1 other identifier
interventional
1,252
7 countries
99
Brief Summary
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedStudy Start
First participant enrolled
April 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
ExpectedMarch 6, 2026
March 1, 2026
4.9 years
February 4, 2021
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The composite of all-cause death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular (CV) causes.
3 years
Secondary Outcomes (8)
Death or NYHA Class III or IV
1 year
Improvement in KCCQ
Baseline to 6 months
6MWD
6 months
All CV hospitalizations through 3 years
3 years
Composite of CV death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular causes through 3 years
3 years
- +3 more secondary outcomes
Study Arms (2)
Impella Arm
EXPERIMENTALImpella CP® or Impella 2.5 placement prior to high-risk PCI
Control Arm
ACTIVE COMPARATORSubjects randomized to the Control group will be treated per standard of care PCI with or without an intra-aortic balloon pump (IABP).
Interventions
IABP uses counterpulsation to provide 0.2L/min coronary flow
Impella CP / Impella CP with SmartAssist will be used in most patients randomized to the Impella arm. Impella 2.5 may be used in patients with small body size (BMI \<20 kg/m2 or body weight \<60 kg) or if the iliofemoral vasculature is able to accommodate the smaller Impella 2.5 device but not the Impella CP device.
Eligibility Criteria
You may qualify if:
- Age ≥18 years and ≤90 years
- 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.
- 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.
- Local heart team (interventional cardiologist and cardiac surgeon) has determined that PCI is indicated and is the most appropriate management for the patient
- 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 \[i.e., not a branch vessel\])
- 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)
- 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
- iv. Intervention of the last remaining vessel (native coronary artery or bypass graft)
- 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)
- +10 more criteria
You may not qualify if:
- 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.)
- 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)
- Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for \>24 hours with full neurologic recovery)
- Cardiorespiratory arrest related to the current admission unless subject is extubated for \>24 hours with full neurologic recovery and hemodynamically stable
- 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:
- 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.
- 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
- Iliofemoral stents placed within 6 months of enrollment with planned vascular access through these vascular segments
- 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)
- Known left ventricular thrombus
- Incessant ventricular arrhythmias that would likely preclude stable Impella positioning
- Severe aortic stenosis or severe aortic insufficiency
- Prior mechanical valve or self-expanding TAVR (NOTE: prior bioprosthetic surgical valve or balloon expandable TAVR implanted \>24 hours pre-procedure is acceptable)
- 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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abiomed Inc.lead
Study Sites (99)
University of Alabama
Birmingham, Alabama, 35294, United States
St. Joseph's Medical Center - Phoenix
Phoenix, Arizona, 85016, United States
Northwest Medical Center Tucson
Tucson, Arizona, 85741, United States
Arkansas Cardiology
Little Rock, Arkansas, 72205, United States
Adventist Health Glendale
Glendale, California, 91206, United States
St. Joseph Hospital - Orange
Orange, California, 92868, United States
Loma Linda University Health
San Bernardino, California, 92354, United States
UCSD Medical Center
San Diego, California, 92093, United States
Colorado Heart and Vascular
Lakewood, Colorado, 80228, United States
The Cardiac & Vascular Institute
Gainesville, Florida, 32605, United States
University of Florida Health - Gainesville
Gainesville, Florida, 32610, United States
UF Health Jacksonville
Jacksonville, Florida, 32209, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Northside Cardiovascular Institute
Lawrenceville, Georgia, 30043, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
NorthShore University Health System
Evanston, Illinois, 60201, United States
Northwestern University
Evanston, Illinois, 60208, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226, United States
Ochsner Foundation Hospital
New Orleans, Louisiana, 70121, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Henry Ford St. John Hospital
Detroit, Michigan, 48236, United States
Corewell Health
Grand Rapids, Michigan, 49435, United States
Metropolitan Heart and Vascular Institute / Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, 55433, United States
CentraCare (St. Cloud Hospital)
Saint Cloud, Minnesota, 56303, United States
SSM Health DePaul Hospital
Bridgeton, Missouri, 63044, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Catholic Medical Center
Manchester, New Hampshire, 03102, United States
Englewood Hospital
Englewood, New Jersey, 07631, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07735, United States
The Valley Hospital - Ridgewood
Ridgewood, New Jersey, 07450, United States
Lovelace/New Mexico Heart Institute
Albuquerque, New Mexico, 87102, United States
University at Buffalo/Kaleida Health
Buffalo, New York, 14203, United States
Northwell University Hospital
Manhasset, New York, 11030, United States
NYU Langone Health
New York, New York, 10016, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029, United States
Columbia University Medical Cenrer/NYPH
New York, New York, 10032, United States
St. Francis Hospital and Heart Center
Roslyn, New York, 11576, United States
Stony Brook University Hospital (SUNY)
Stony Brook, New York, 11794, United States
Montefiore Medical Center - Moses
The Bronx, New York, 10467-2401, United States
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204, United States
Duke University
Durham, North Carolina, 27710, United States
North Carolina Heart and Vascular Research
Raleigh, North Carolina, 27607, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Linder Research Center (The Christ Hospital)
Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73104, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
WellSpan York Hospital
York, Pennsylvania, 17403, United States
Wellmont Cardiology Services
Kingsport, Tennessee, 37660, United States
Centennial Heart - Nashville
Nashville, Tennessee, 37203, United States
Ascension St. Thomas West
Nashville, Tennessee, 37205, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Presbyterian Hospital Dallas / Texas Health Physicians Group
Dallas, Texas, 75231, United States
Medical City Fort Worth
Fort Worth, Texas, 76104, United States
HCA Houston Healthcare
Houston, Texas, 77004, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Memorial Hermann Texas Medical Center (UT Health)
Houston, Texas, 77030, United States
Texas Heart Institute at Baylor St. Luke's Hospital
Houston, Texas, 77030, United States
Texas Cardiology Associates of Houston
Kingwood, Texas, 77339, United States
Baylor Scott & White Heart - Plano
Plano, Texas, 75093, United States
Methodist Hospital - San Antonio
San Antonio, Texas, 78229, United States
Sentara Norfolk Health System
Norfolk, Virginia, 23507, United States
Carilion Clinic
Roanoke, Virginia, 24014, United States
University Of Washington Medical Center
Seattle, Washington, 98195, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Toronto General Hospital
Toronto, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
Klinikum rechts der Isar der TUM
Munich, Bavaria, 81675, Germany
Klinikum Karlsburg
Karlsburg, Mecklenburg-Vorpommern, 17495, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Krankenhaus der Barmherzigen Brüder
Trier, Rhineland-Palatinate, 54292, Germany
University Hospital Aachen
Aachen, 52074, Germany
Universitätsklinikum Freiburg, Universitäts-Herzzentrum
Bad Krozingen, 79189, Germany
Berlin CBF
Berlin, 12203, Germany
CVK Berlin
Berlin, 13353, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09116, Germany
St. Vinzenz-Hospital GMBH KÖLN
Cologne, 50733, Germany
Herzzentrum Dresden GmbH
Dresden, 01307, Germany
University Hopsital Frankfurt
Frankfurt, Germany
Klinikum Friedrichshafen GmbH
Friedrichshafen, 88048, Germany
Universitätsklinikum Gießen
Giessen, 35392, Germany
Uniklinik Würzburg
Würzburg, 97080, Germany
Policlinico Universitario Agostino Gemelli
Rome, RM, 00168, Italy
Ospedale di San Donato
San Donato Milanese, Italy
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, 5623 EJ, Netherlands
Istituto Cardiocentro Ticino
Lugano, Canton Ticino, 6900, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
Luzerner Kantonsspital
Lucerne, 6000, Switzerland
Royal Brompton Hospital
London, United Kingdom
Related Publications (1)
Lusebrink E, Kellnar A, Krieg K, Binzenhofer L, Scherer C, Zimmer S, Schrage B, Fichtner S, Petzold T, Braun D, Peterss S, Brunner S, Hagl C, Westermann D, Hausleiter J, Massberg S, Thiele H, Schafer A, Orban M. Percutaneous Transvalvular Microaxial Flow Pump Support in Cardiology. Circulation. 2022 Apr 19;145(16):1254-1284. doi: 10.1161/CIRCULATIONAHA.121.058229. Epub 2022 Apr 18.
PMID: 35436135DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2021
First Posted
February 21, 2021
Study Start
April 13, 2021
Primary Completion
March 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
March 6, 2026
Record last verified: 2026-03