ACTIVE_NOT_RECRUITING

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

Conditions

Left Ventricular Dysfunction Coronary Artery Disease Non-ST Elevated Myocardial Infarction Cardiovascular Diseases Heart Diseases Myocardial Ischemia Myocardial Infarction Anterior Wall Myocardial Infarction Inferior Wall Myocardial Infarction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-04-13

Study Completion:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04763200

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.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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 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: 5. Subject or legal guardian (permitted at US sites only) agrees to randomization and to follow all study procedures and provides informed, written consent	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) 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. 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)

Inclusion Criteria

Exclusion 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
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
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:
5. Subject or legal guardian (permitted at US sites only) agrees to randomization and to follow all study procedures and provides informed, written consent

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)
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.
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)

Contacts and Locations

Study Locations (Sites)

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

Keck School of Medicine of USC

Los Angeles, California, 90036

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

Hartford Hospital

Hartford, Connecticut, 06106

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, 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

Montefiore Medical Center - Moses

Bronx, New York, 10467-2401

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

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

Greenville Hospital System

Greenville, South Carolina, 29605

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

Collaborators and Investigators

Sponsor: Abiomed Inc.

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 Registration Dates

Study Start Date2021-04-13

Study Completion Date2027-10

Study Record Updates

Study Start Date2021-04-13

Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

Non-ST Elevated Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Myocardial Infarction
Anterior Wall Myocardial Infarction
Inferior Wall Myocardial Infarction

Additional Relevant MeSH Terms

Left Ventricular Dysfunction
Coronary Artery Disease