Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function (PROTECT IV)

December 29, 2023 updated by: Abiomed Inc.

Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To demonstrate that in high-risk patients with complex CAD and reduced left ventricular function undergoing PCI, PCI with Impella MCS is superior to PCI without Impella MCS in reducing the composite rate of all-cause death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular causes at 3-year follow-up.

Study Type

Interventional

Enrollment (Estimated)

1252

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Charles (Chuck) Simonton, MD FACC FSCAI
Phone Number: 978-646-1597
Email: csimonton@abiomed.com

Study Contact Backup

Name: Adam Thompson
Phone Number: 208-271-1610
Email: adthompson@abiomed.com

Study Locations

Canada
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 2A6
    - Not yet recruiting
    - St. Boniface Hospital
    - Principal Investigator:
      
      David Allen
- Ontario
  - Toronto, Ontario, Canada
    - Not yet recruiting
    - Toronto General Hospital
    - Principal Investigator:
      
      Sanjog Kalra
Germany
- - Aachen, Germany, 52074
    - Recruiting
    - University Hospital Aachen
    - Principal Investigator:
      
      Jörg Schröder
  - Bad Krozingen, Germany, 79189
    - Recruiting
    - Universitätsklinikum Freiburg, Universitäts-Herzzentrum
    - Principal Investigator:
      
      Miroslaw Ferenc
  - Bad Segeberg, Germany, 23795
    - Not yet recruiting
    - Segeberger Kliniken GmbH
    - Principal Investigator:
      
      Abdelhakim Allali
  - Berlin, Germany, 12203
    - Recruiting
    - Berlin CBF
    - Principal Investigator:
      
      Carsten Skurk
  - Berlin, Germany, 13353
    - Recruiting
    - CVK Berlin
    - Principal Investigator:
      
      Mohammad Sherif
  - Chemnitz, Germany, 09116
    - Recruiting
    - Klinikum Chemnitz gGmbH
    - Principal Investigator:
      
      Karim Ibrahim
  - Dresden, Germany, 01307
    - Recruiting
    - Herzzentrum Dresden GmbH
    - Principal Investigator:
      
      Norman Mangner
  - Essen, Germany, 45147
    - Recruiting
    - Universitätsklinikum Essen AöR
    - Principal Investigator:
      
      Tienush Rassaf
  - Friedrichshafen, Germany, 88048
    - Recruiting
    - Klinikum Friedrichshafen GmbH
    - Principal Investigator:
      
      Jochen Wöhrle
  - Gießen, Germany, 35392
    - Recruiting
    - Universitätsklinikum Gießen
    - Principal Investigator:
      
      Holger Nef
  - Köln, Germany, 50733
    - Recruiting
    - St. Vinzenz-Hospital Gmbh Köln
    - Principal Investigator:
      
      Jan-Malte Sinning
  - Würzburg, Germany, 97080
    - Recruiting
    - Uniklinik Würzburg
    - Principal Investigator:
      
      Peter Nordbeck
- Bayern
  - Erlangen, Bayern, Germany, 91054
    - Recruiting
    - Universitätsklinikum Erlangen
    - Principal Investigator:
      
      Stephan Achenbach
- Mecklenburg-Vorpommern
  - Karlsburg, Mecklenburg-Vorpommern, Germany, 17495
    - Recruiting
    - Klinikum Karlsburg
    - Principal Investigator:
      
      Alkhlout
- NRW
  - Düsseldorf, NRW, Germany, 40225
    - Not yet recruiting
    - Universitatsklinikum Dusseldorf
    - Principal Investigator:
      
      Ralf Westenfeld
- Rheinland-Pfalz
  - Trier, Rheinland-Pfalz, Germany, 54292
    - Recruiting
    - Krankenhaus der Barmherzigen Brüder
    - Principal Investigator:
      
      Nikos Werner
Italy
- - Napoli, Italy, 80122
    - Not yet recruiting
    - Clinica Mediterranea
    - Principal Investigator:
      
      Briguori
- Lombardy
  - Rozzano, Lombardy, Italy, 20089
    - Not yet recruiting
    - Humanitas Clinical & Research Hospital
    - Principal Investigator:
      
      Antonio Colombo
- RM
  - Rome, RM, Italy, 00168
    - Not yet recruiting
    - Policlinico Universitario Agostino Gemelli
    - Principal Investigator:
      
      Trani
Netherlands
- North Brabant
  - Eindhoven, North Brabant, Netherlands, 5623 EJ
    - Recruiting
    - Catharina Ziekenhuis Eindhoven
    - Principal Investigator:
      
      Koen Teeuwen
- Zuid
  - Leiden, Zuid, Netherlands, 2333 ZA
    - Not yet recruiting
    - LUMC-Leids Universitair Medisch Centrum
    - Principal Investigator:
      
      José Montero-Cabezas
Switzerland
- - Bern, Switzerland, 3010
    - Recruiting
    - Inselspital Bern
    - Principal Investigator:
      
      Lukas Hunziker
  - Luzern, Switzerland, 6000
    - Recruiting
    - Luzerner Kantonsspital
    - Principal Investigator:
      
      Florim Cuculi
- Tessin
  - Lugano, Tessin, Switzerland, 6900
    - Recruiting
    - Istituto Cardiocentro Ticino
    - Principal Investigator:
      
      Marco Vaglimigli
United Kingdom
- - London, United Kingdom
    - Not yet recruiting
    - Royal Brompton Hospital
    - Principal Investigator:
      
      Jonathan Hill
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - Recruiting
    - University of Alabama
    - Principal Investigator:
      
      Mustafa Ahmed, MD
- Arizona
  - Phoenix, Arizona, United States, 85016
    - Withdrawn
    - Abrazo Arizona Heart
  - Phoenix, Arizona, United States, 85016
    - Recruiting
    - St. Joseph's Medical Center - Phoenix
    - Principal Investigator:
      
      Hursh Naik, MD
  - Tucson, Arizona, United States, 85712
    - Not yet recruiting
    - Tucson Medical Center Healthcare
    - Principal Investigator:
      
      Thomas Waggoner, DO
  - Tucson, Arizona, United States, 85741
    - Recruiting
    - Northwest Medical Center Tucson
    - Principal Investigator:
      
      Dexter Deleon, MD
- Arkansas
  - Fayetteville, Arkansas, United States, 72703
    - Not yet recruiting
    - Washington Regional Medical Center - Walker Heart Institute
    - Principal Investigator:
      
      Joel Carver, MD
  - Little Rock, Arkansas, United States, 72205
    - Recruiting
    - Arkansas Cardiology
    - Principal Investigator:
      
      Ernesto Ruiz-Rodriguez, MD
- California
  - Burlingame, California, United States, 94010
    - Not yet recruiting
    - Mills-Peninsula Medical Center
    - Principal Investigator:
      
      Elliot Groves, MD
  - Fresno, California, United States, 93720
    - Not yet recruiting
    - Saint Agnes Medical Center
    - Principal Investigator:
      
      Alfred Valles, MD
  - Glendale, California, United States, 91206
    - Recruiting
    - Adventist Health Glendale
    - Principal Investigator:
      
      Hambik Tankazyan, MD
  - Los Angeles, California, United States, 90048
    - Not yet recruiting
    - Cedars-Sinai Medical Center
    - Principal Investigator:
      
      Suhail Dohad, MD
  - Orange, California, United States, 92868
    - Recruiting
    - St. Joseph Hospital - Orange
    - Principal Investigator:
      
      Brian Kolski, MD
  - San Bernardino, California, United States, 92354
    - Recruiting
    - Loma Linda University Health
    - Principal Investigator:
      
      Aditya Bharadwaj, MD
  - San Diego, California, United States, 92093
    - Recruiting
    - UCSD Medical Center
    - Principal Investigator:
      
      Ehtisham Mahmud, MD
  - Torrance, California, United States, 90505
    - Not yet recruiting
    - Torrance Memorial Medical Center
    - Principal Investigator:
      
      Michael Wyman, MD
- Colorado
  - Lakewood, Colorado, United States, 80228
    - Recruiting
    - Colorado Heart and Vascular
    - Principal Investigator:
      
      John Altman, MD
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - Recruiting
    - MedStar Washington Hospital Center
    - Principal Investigator:
      
      Hayder Hashim, MD
- Florida
  - Daytona Beach, Florida, United States, 32117
    - Not yet recruiting
    - Cardiology Associates Research Company
    - Principal Investigator:
      
      Nathan Valin, MD
  - Gainesville, Florida, United States, 32605
    - Recruiting
    - The Cardiac & Vascular Institute
    - Principal Investigator:
      
      Matheen Khuddus, MD
  - Gainesville, Florida, United States, 32610
    - Recruiting
    - University of Florida Health - Gainesville
    - Principal Investigator:
      
      R. David Anderson, MD
  - Jacksonville, Florida, United States, 32209
    - Recruiting
    - Uf Health Jacksonville
    - Principal Investigator:
      
      Daniel Soffer, MD
  - Tampa, Florida, United States, 33613
    - Not yet recruiting
    - AdventHealth - Tampa
    - Principal Investigator:
      
      James Smith, MD
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Emory University Hospital
    - Principal Investigator:
      
      William Nicholson, MD
  - Lawrenceville, Georgia, United States, 30043
    - Recruiting
    - Northside Cardiovascular Institute
    - Principal Investigator:
      
      Michele Voeltz, MD
  - Marietta, Georgia, United States, 30060
    - Withdrawn
    - Wellstar Kennestone Hospital
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Not yet recruiting
    - The Queen's Medical Center
    - Principal Investigator:
      
      Benjamin Plank, MD
- Illinois
  - Chicago, Illinois, United States, 60612
    - Not yet recruiting
    - Rush University Medical Center
    - Principal Investigator:
      
      Hussam Suradi, MD
  - Evanston, Illinois, United States, 60208
    - Recruiting
    - Northwestern University
    - Principal Investigator:
      
      Keith Benzuly, MD
  - Evanston, Illinois, United States, 60201
    - Recruiting
    - NorthShore University Health System
    - Principal Investigator:
      
      Mark Ricciardi, MD
  - Oak Lawn, Illinois, United States, 60453
    - Recruiting
    - Advocate Christ Medical Center
    - Principal Investigator:
      
      Thomas Levin, MD
  - Springfield, Illinois, United States, 62781
    - Not yet recruiting
    - Memorial Medical Center
    - Principal Investigator:
      
      Tony DeMartini, MD
- Kentucky
  - Louisville, Kentucky, United States, 40205
    - Recruiting
    - Norton Healthcare - Norton Heart Specialists
    - Principal Investigator:
      
      Sean Stewart, MD
- Louisiana
  - Lafayette, Louisiana, United States, 70596
    - Not yet recruiting
    - Cardiovascular Institute of the South (Lafayette General Medical Center)
    - Principal Investigator:
      
      Louis Salvaggio, MD
  - New Orleans, Louisiana, United States, 70121
    - Recruiting
    - Ochsner Foundation Hospital
    - Principal Investigator:
      
      Rajan Patel, MD
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Massachusetts General Hospital
    - Principal Investigator:
      
      Rahul Sakhuja, MD
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Beth Israel Deaconess Medical Center
    - Principal Investigator:
      
      Robert Yeh, MD
  - Boston, Massachusetts, United States, 02111
    - Recruiting
    - Tufts Medical Center
    - Principal Investigator:
      
      Navin Kapur, MD
- Michigan
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Hospital
    - Principal Investigator:
      
      Mir B. Basir, DO
  - Detroit, Michigan, United States, 48236
    - Recruiting
    - Ascension St. John Hospital
    - Principal Investigator:
      
      Amir Kaki, MD
  - Grand Rapids, Michigan, United States, 49435
    - Recruiting
    - Spectrum Health
    - Principal Investigator:
      
      David Wohns, MD
- Minnesota
  - Coon Rapids, Minnesota, United States, 55433
    - Recruiting
    - Metropolitan Heart and Vascular Institute / Metropolitan Cardiology Consultants
    - Principal Investigator:
      
      Jeffrey Chambers, MD
  - Saint Cloud, Minnesota, United States, 56303
    - Recruiting
    - CentraCare (St. Cloud Hospital)
    - Principal Investigator:
      
      Thom Dahle, MD
- Missouri
  - Bridgeton, Missouri, United States, 63044
    - Recruiting
    - SSM Health DePaul Hospital
    - Principal Investigator:
      
      Divya Verma, MD
  - Kansas City, Missouri, United States, 64111
    - Recruiting
    - St. Luke's Hospital
    - Principal Investigator:
      
      Adam Salisbury, MD
  - Saint Louis, Missouri, United States, 63131
    - Not yet recruiting
    - Missouri Baptist Medical Center
    - Contact:
      
      Marc Haynes
      
      Email: mph7052@bjc.org
    - Principal Investigator:
      
      Gus Theodos
- New Hampshire
  - Manchester, New Hampshire, United States, 03102
    - Recruiting
    - Catholic Medical Center
    - Principal Investigator:
      
      Stephan Heo, MD
- New Jersey
  - Englewood, New Jersey, United States, 07631
    - Not yet recruiting
    - Englewood Hospital
    - Principal Investigator:
      
      Aaron Schwarcz, MD
  - Hackensack, New Jersey, United States, 07601
    - Recruiting
    - Hackensack University Medical Center
    - Principal Investigator:
      
      Haroon Faraz, MD
  - Morristown, New Jersey, United States, 07960
    - Recruiting
    - Morristown Medical Center
    - Principal Investigator:
      
      Dimitrios Karmpaliotis, MD
  - Neptune, New Jersey, United States, 07735
    - Recruiting
    - Jersey Shore University Medical Center
    - Principal Investigator:
      
      Aditya Mehra, MD
  - New Brunswick, New Jersey, United States, 08901
    - Withdrawn
    - Robert Wood Johnson Medical School & Robert Wood Johnson University Hospital
  - Ridgewood, New Jersey, United States, 07450
    - Recruiting
    - The Valley Hospital - Ridgewood
    - Principal Investigator:
      
      Rajiv Tayal
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Recruiting
    - Lovelace/New Mexico Heart Institute
    - Principal Investigator:
      
      Raymond Yau, MD
- New York
  - Bronx, New York, United States, 10467-2401
    - Recruiting
    - Montefiore Medical Center - Moses
    - Principal Investigator:
      
      Dimitrios Bliagos, MD
  - Buffalo, New York, United States, 14203
    - Recruiting
    - University at Buffalo/Kaleida Health
    - Principal Investigator:
      
      Vijay S. Iyer, MD
  - Manhasset, New York, United States, 11030
    - Recruiting
    - Northwell University Hospital
    - Principal Investigator:
      
      Perwaiz Meraj, MD
  - New York, New York, United States, 10016
    - Recruiting
    - NYU Langone Health
    - Principal Investigator:
      
      Craig Thompson, MD
  - New York, New York, United States, 10029
    - Recruiting
    - Icahn School of Medicine at Mt. Sinai
    - Principal Investigator:
      
      Samin Sharma, MD
  - New York, New York, United States, 10032
    - Recruiting
    - Columbia University Medical Cenrer/NYPH
    - Principal Investigator:
      
      Michael Collins, MD
  - Roslyn, New York, United States, 11576
    - Recruiting
    - St. Francis Hospital and Heart Center
    - Principal Investigator:
      
      Allen Jeremias, MD
  - Stony Brook, New York, United States, 11794
    - Recruiting
    - Stony Brook University Hospital (SUNY)
    - Principal Investigator:
      
      Robert Pyo, MD
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Sanger Heart and Vascular Institute
    - Principal Investigator:
      
      Nyal Borges, MD
  - Raleigh, North Carolina, United States, 27607
    - Recruiting
    - North Carolina Heart and Vascular Research
    - Principal Investigator:
      
      Robert Jobe, MD
  - Winston-Salem, North Carolina, United States, 27157
    - Recruiting
    - Wake Forest University Health Sciences
    - Principal Investigator:
      
      Peter M Belford, MD
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Recruiting
    - Linder Research Center (The Christ Hospital)
    - Principal Investigator:
      
      Timothy Smith, MD
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Cleveland Clinic Foundation
    - Principal Investigator:
      
      Jaikirshan Khatri, MD
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Recruiting
    - University of Oklahoma Medical Center
    - Principal Investigator:
      
      Usman Baber, MD
- Oregon
  - Portland, Oregon, United States, 97225
    - Recruiting
    - Providence St. Vincent Medical Center
    - Principal Investigator:
      
      Jason Wollmuth, MD
  - Portland, Oregon, United States, 97232
    - Recruiting
    - Legacy Emanuel Hospital & Health Center
    - Principal Investigator:
      
      Amish Desai, MD
  - Portland, Oregon, United States, 97239
    - Not yet recruiting
    - Oregon Health and Science University
    - Contact:
      
      Harsh Golwala, MD
      
      Email: golwala@ohsu.edu
    - Principal Investigator:
      
      Harsh Golwala, MD
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Recruiting
    - Lehigh Valley Health Network
    - Principal Investigator:
      
      Nainesh Patel, MD
  - Pittsburgh, Pennsylvania, United States, 15212
    - Recruiting
    - Allegheny General Hospital
    - Principal Investigator:
      
      Mithun Chakravarthy, MD
  - York, Pennsylvania, United States, 17403
    - Recruiting
    - Wellspan York Hospital
    - Principal Investigator:
      
      Paul Tolerico, MD
- South Carolina
  - Greenville, South Carolina, United States, 29605
    - Recruiting
    - Greenville Hospital System
    - Principal Investigator:
      
      Jesse Jorgensen
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Recruiting
    - Monument Health Clinical Research
    - Principal Investigator:
      
      Bhaskar Purushottam
- Tennessee
  - Kingsport, Tennessee, United States, 37660
    - Recruiting
    - Wellmont Cardiology Services
    - Principal Investigator:
      
      D. Christopher Metzger, MD
  - Knoxville, Tennessee, United States, 37923
    - Recruiting
    - Parkwest Medical Center
    - Principal Investigator:
      
      Ayaz Rahman, MD
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Vanderbilt University Medical Center
    - Principal Investigator:
      
      Colin Barker, MD
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Centennial Heart - Nashville
    - Principal Investigator:
      
      Andrew Goodman, MD
  - Nashville, Tennessee, United States, 37205
    - Recruiting
    - Ascension St. Thomas West
    - Principal Investigator:
      
      Elias Haddad, MD
- Texas
  - Dallas, Texas, United States, 75231
    - Recruiting
    - Presbyterian Hospital Dallas / Texas Health Physicians Group
    - Principal Investigator:
      
      James Park, MD
  - Fort Worth, Texas, United States, 76104
    - Recruiting
    - Medical City Fort Worth
    - Principal Investigator:
      
      Amir Malik, MD
  - Galveston, Texas, United States, 77555
    - Not yet recruiting
    - University of Texas Medical Branch (UTMB) Galveston
    - Principal Investigator:
      
      Syed Gilani, MD
  - Houston, Texas, United States, 77004
    - Recruiting
    - HCA Houston Healthcare
    - Principal Investigator:
      
      Pranav Loyalka, MD
  - Houston, Texas, United States, 77030
    - Recruiting
    - Memorial Hermann Texas Medical Center (UT Health)
    - Principal Investigator:
      
      Sachin Kumar, MD
  - Houston, Texas, United States, 77030
    - Not yet recruiting
    - Texas Heart Institute at Baylor St. Luke's Hospital
    - Principal Investigator:
      
      Samar Sheth, MD
  - Kingwood, Texas, United States, 77339
    - Recruiting
    - Texas Cardiology Associates of Houston
    - Principal Investigator:
      
      Robert Salazar, MD
  - Plano, Texas, United States, 75093
    - Recruiting
    - Baylor Scott & White Heart - Plano
    - Principal Investigator:
      
      Sameh Sayfo, MD
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Methodist Hospital - San Antonio
    - Principal Investigator:
      
      Nandish Thukral, MD
- Virginia
  - Norfolk, Virginia, United States, 23507
    - Recruiting
    - Sentara Norfolk Health System
    - Principal Investigator:
      
      Paul Lavigne, MD
  - Richmond, Virginia, United States, 23219
    - Not yet recruiting
    - VCU Medical Center
    - Principal Investigator:
      
      Lorenzo Azzalini, MD
  - Roanoke, Virginia, United States, 24014
    - Recruiting
    - Carilion Clinic
    - Principal Investigator:
      
      Chalak Berzingi, MD
- Washington
  - Seattle, Washington, United States, 98195
    - Recruiting
    - University of Washington Medical Center
    - Principal Investigator:
      
      Kathleen Kearney, MD
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - Recruiting
    - West Virginia University Hospital
    - Principal Investigator:
      
      Ramesh Daggubati,, MD
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Medical College of Wisconsin
    - Contact:
      
      Barbara Shimada-Krouwer, RN
      
      Email: bshikrouwer@mcw.edu
    - Principal Investigator:
      
      Iyad Azzam, MD
  - Milwaukee, Wisconsin, United States, 53215
    - Recruiting
    - Aurora St. Luke's Medical Center
    - Principal Investigator:
      
      Lous Kostopoulos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.
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.
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])
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)
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:

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:
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
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.
NOTE: Successful PCI for this exclusion criterion is defined as a visually-assessed angiographic DS ≤50% in at least one (1) attempted lesion.
Prior placement of IABP, Impella or any other MCS device for any reason during the index admission, prior to randomization
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
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)
Severe tricuspid insufficiency
Platelet count <75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwilling to receive blood transfusions
On dialysis
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
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)
Plan for any surgery within 6 months necessitating discontinuing antiplatelet agents
Pregnant or child-bearing potential unless negative pregnancy test within 1 week
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
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
Any non-cardiac condition with life expectancy <3 years (e.g., cirrhosis, oxygen or oral steroid dependent COPD, cancer not in remission, etc.)
Subject is currently hospitalized for definite or suspected COVID-19
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
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
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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Impella Arm Impella CP® or Impella 2.5 placement prior to high-risk PCI	Device: Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® 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.
Active Comparator: Control Arm Subjects randomized to the Control group will be treated per standard of care PCI with or without an intra-aortic balloon pump (IABP).	Device: IABP Intra-aortic balloon pump IABP uses counterpulsation to provide 0.2L/min coronary flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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. Time Frame: 3 years	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Death or NYHA Class III or IV Time Frame: 1 year	1 year
Improvement in KCCQ Time Frame: Baseline to 6 months	Baseline to 6 months
6MWD Time Frame: 6 months	6 months
All CV hospitalizations through 3 years Time Frame: 3 years	3 years
CV death or HF hospitalizations through 3 years Time Frame: 3 years	3 years
Improvement in LVEF based on ANCOVA regression with inclusion of baseline LVEF measurement as a covariate Time Frame: Baseline to 6 months	Baseline to 6 months
Achievement of complete anatomic revascularization after the index and planned staged procedures Time Frame: 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 Time Frame: 3 years	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abiomed Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2021

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

VV-TMF-18508

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®

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