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

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: Active, not recruiting
• Conditions: Coronary Artery Disease; Left Ventricular Dysfunction
• Intervention / Treatment: Device: Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®; Device: IABP Intra-aortic balloon pump

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

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Toronto General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Royal Victoria Hospital
• Germany
  • Aachen, Germany, 52074
    • University Hospital Aachen
  • Bad Krozingen, Germany, 79189
    • Universitätsklinikum Freiburg, Universitäts-Herzzentrum
  • Berlin, Germany, 12203
    • Berlin CBF
  • Berlin, Germany, 13353
    • CVK Berlin
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Cologne, Germany, 50733
    • St. Vinzenz-Hospital GMBH KÖLN
  • Dresden, Germany, 01307
    • Herzzentrum Dresden GmbH
  • Frankfurt, Germany
    • University Hopsital Frankfurt
  • Friedrichshafen, Germany, 88048
    • Klinikum Friedrichshafen GmbH
  • Giessen, Germany, 35392
    • Universitätsklinikum Giessen
  • Würzburg, Germany, 97080
    • Uniklinik Würzburg
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Universitätsklinikum Erlangen
    • Munich, Bavaria, Germany, 81675
      • Klinikum rechts der Isar der TUM
  • Mecklenburg-Vorpommern
    • Karlsburg, Mecklenburg-Vorpommern, Germany, 17495
      • Klinikum Karlsburg
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • Universitätsklinikum Düsseldorf
  • Rhineland-Palatinate
    • Trier, Rhineland-Palatinate, Germany, 54292
      • Krankenhaus der Barmherzigen Brüder
• Italy
  • San Donato Milanese, Italy
    • Ospedale di San Donato
  • RM
    • Rome, RM, Italy, 00168
      • Policlinico Universitario Agostino Gemelli
• Netherlands
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5623 EJ
      • Catharina Ziekenhuis Eindhoven
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern
  • Lucerne, Switzerland, 6000
    • Luzerner Kantonsspital
  • Canton Ticino
    • Lugano, Canton Ticino, Switzerland, 6900
      • Istituto Cardiocentro Ticino
• United Kingdom
  • London, United Kingdom
    • Royal Brompton Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • St. Joseph's Medical Center - Phoenix
    • Tucson, Arizona, United States, 85741
      • Northwest Medical Center Tucson
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Cardiology
  • California
    • Glendale, California, United States, 91206
      • Adventist Health Glendale
    • Orange, California, United States, 92868
      • St. Joseph Hospital - Orange
    • San Bernardino, California, United States, 92354
      • Loma Linda University health
    • San Diego, California, United States, 92093
      • UCSD Medical Center
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Heart and Vascular
  • Florida
    • Gainesville, Florida, United States, 32605
      • The Cardiac & Vascular Institute
    • Gainesville, Florida, United States, 32610
      • University of Florida Health - Gainesville
    • Jacksonville, Florida, United States, 32209
      • UF Health Jacksonville
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Lawrenceville, Georgia, United States, 30043
      • Northside Cardiovascular Institute
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Evanston, Illinois, United States, 60208
      • Northwestern University
    • Evanston, Illinois, United States, 60201
      • Northshore University Health System
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cardiovascular Research Institute of Kansas
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Foundation Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48236
      • Henry Ford St. John Hospital
    • Grand Rapids, Michigan, United States, 49435
      • Corewell Health
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Metropolitan Heart and Vascular Institute / Metropolitan Cardiology Consultants
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare (St. Cloud Hospital)
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • SSM Health DePaul Hospital
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
    • Neptune City, New Jersey, United States, 07735
      • Jersey Shore University Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital - Ridgewood
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Lovelace/New Mexico Heart Institute
  • New York
    • Buffalo, New York, United States, 14203
      • University at Buffalo/Kaleida Health
    • Manhasset, New York, United States, 11030
      • Northwell University Hospital
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mt. Sinai
    • New York, New York, United States, 10032
      • Columbia University Medical Cenrer/NYPH
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital and Heart Center
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital (SUNY)
    • The Bronx, New York, United States, 10467-2401
      • Montefiore Medical Center - Moses
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Sanger Heart and Vascular Institute
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Heart and Vascular Research
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Linder Research Center (The Christ Hospital)
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Medical Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • York, Pennsylvania, United States, 17403
      • Wellspan York Hospital
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Cardiology Services
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37205
      • Ascension St. Thomas West
    • Nashville, Tennessee, United States, 37203
      • Centennial Heart - Nashville
  • Texas
    • Dallas, Texas, United States, 75231
      • Presbyterian Hospital Dallas / Texas Health Physicians Group
    • Fort Worth, Texas, United States, 76104
      • Medical City Fort Worth
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77004
      • HCA Houston Healthcare
    • Houston, Texas, United States, 77030
      • Memorial Hermann Texas Medical Center (UT Health)
    • Houston, Texas, United States, 77030
      • Texas Heart Institute at Baylor St. Luke's Hospital
    • Kingwood, Texas, United States, 77339
      • Texas Cardiology Associates of Houston
    • Plano, Texas, United States, 75093
      • Baylor Scott & White Heart - Plano
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital - San Antonio
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk Health System
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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.	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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
CV death or HF hospitalizations through 3 years	3 years
Improvement in LVEF based on ANCOVA regression with inclusion of baseline LVEF measurement as a covariate	Baseline to 6 months
Achievement of complete anatomic revascularization after the index and planned staged procedures	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

Collaborators and Investigators

• Sponsor: Abiomed Inc.

Publications and helpful links

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

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 (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Myocardial Infarction; Heart Diseases; Myocardial Ischemia; Non-ST Elevated Myocardial Infarction; Anterior Wall Myocardial Infarction; Inferior Wall Myocardial Infarction
• Additional Relevant MeSH Terms: Vascular Diseases; Pathologic Processes; Infarction; Necrosis; Ventricular Dysfunction; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Ischemia; Pathological Conditions, Signs and Symptoms; Non-ST Elevated Myocardial Infarction; Cardiovascular Diseases; Heart Diseases; Ventricular Dysfunction, Left; Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Anterior Wall Myocardial Infarction; Inferior Wall Myocardial Infarction
• Other Study ID Numbers: VV-TMF-18508

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes