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

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ClinicalTrials.gov Identifier: NCT04763200
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Abiomed Inc.

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.

Condition or disease Intervention/treatment Phase
Left Ventricular Dysfunction Coronary Artery Disease Device: Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® Device: IABP Intra-aortic balloon pump Not Applicable

Detailed Description:
To demonstrate that in high-risk patients with complex CAD and reduced left ventricular function undergoing PCI, PCI with Impella Mechanical Circulatory Support (MCS) is superior to PCI without Impella MCS in reducing the composite rate of all-cause death, stroke, MI or hospitalization for cardiovascular causes at 3-year follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, multicenter, randomized, parallel-controlled, open-label two-arm trial with an adaptive design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial
Actual Study Start Date : April 13, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The composite of all-cause death, stroke, MI or hospitalization for cardiovascular (CV) causes. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Death or NYHA Class III or IV [ Time Frame: 1-year ]
  2. Improvement in KCCQ [ Time Frame: Baseline to 6-months ]
  3. 6MWD [ Time Frame: 6-months ]
  4. All CV hospitalizations [ Time Frame: 3 years ]
  5. Composite of CV death, stroke, MI or hospitalization for cardiovascular cause [ Time Frame: 3 years ]
  6. CV death or HF hospitalizations [ Time Frame: 3 years ]
  7. Improvement in LVEF based on ANCOVA regression with inclusion of baseline LVEF measurement as a covariate [ Time Frame: Baseline to 6-months ]
  8. Complete ischemic revascularization evaluated using Pearson's chi-square test for proportion difference [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 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) or contrast angiography to assess the aorta and iliofemoral vasculature to ensure Impella compatibility must be performed within 14 days of the planned randomization. Absent a CT, angiography of the potential Impella access vessel(s) may be performed in the Cath Lab before the planned enrollment after which the subject may be randomized if he/she still qualifies
    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. 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
  13. Moderate or severe RV dysfunction defined as TAPSE <12 mm or RVFAC ≤30% as assessed on baseline TTE (NOTE: these measures may be quantified at the site; if the site determines qualitatively that some degree of RV dysfunction is present or the subject has signs or symptoms of RV dysfunction but the site is unable to quantitate RV function, the echo must be submitted for Core Laboratory assessment prior to subject enrollment)
  14. Platelet count <75,000 cells/mm3, bleeding diathesis, coagulopathy or unwilling to receive blood transfusions
  15. On dialysis
  16. Prior stroke with any permanent neurologic deficit 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
  17. Taking a chronic oral anticoagulant that cannot be safely discontinued for at least 72-hours before and 72-hours after the index procedure
  18. Plan for any surgery within 6 months necessitating discontinuing antiplatelet agents
  19. Pregnant or child-bearing potential unless negative pregnancy test within 1 week
  20. 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
  21. 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
  22. Any non-cardiac condition with life expectancy <3 years (e.g., cirrhosis, oxygen or oral steroid dependent COPD, cancer not in remission, etc.)
  23. Subject is currently hospitalized for definite or suspected COVID-19
  24. Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥8 weeks and has returned to his/her prior baseline (pre-COVID) clinical condition
  25. Subject is asymptomatic (never ill) and COVID-19 PCR/antigen or antibody test is positive within the prior 4 weeks unless subject remains asymptomatic for ≥4 weeks after the last positive test
  26. Subject belongs to a vulnerable population (defined as individuals with mental disability, persons in nursing homes, 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763200


Contacts
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Contact: Charles (Chuck) Simonton, MD FACC FSCAI 978-646-1597 csimonton@abiomed.com
Contact: Adam Thompson 208-271-1610 adthompson@abiomed.com

Locations
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United States, Alabama
University of Alabama Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Susan Binkley         
Principal Investigator: Mustafa Ahmed, MD         
United States, California
UCSD Medical Center Not yet recruiting
San Diego, California, United States, 92093
Contact: Bahman Ghannadian         
Principal Investigator: Ehtisham Mahmud, MD         
United States, Georgia
Northside Cardiovascular Institute Not yet recruiting
Lawrenceville, Georgia, United States, 30043
Contact: Kimberly Kelly         
Principal Investigator: Michele Voeltz, MD         
United States, Illinois
North Shore University Health System Not yet recruiting
Evanston, Illinois, United States, 60201
Contact: Ujala Bokhary         
Principal Investigator: Mark Ricciardi, MD         
Northwestern University Not yet recruiting
Evanston, Illinois, United States, 60208
Contact: CTU Regulatory Team       CTURegulatoryTeam@nm.org   
Principal Investigator: Keith Benzuly, MD         
United States, Louisiana
Ochsner Foundation Hospital Not yet recruiting
New Orleans, Louisiana, United States, 70121
Contact: Hunter McDaniel         
Principal Investigator: Rajan Patel, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Jenifer Kaufman         
Principal Investigator: Robert Yeh, MD         
United States, Michigan
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Margaret Fox         
Principal Investigator: Mir B. Basir, DO         
Ascension St. John Hospital Recruiting
Detroit, Michigan, United States, 48236
Contact: Renee Bess         
Principal Investigator: Amir Kaki, MD         
United States, Minnesota
CentraCare (St. Cloud Hospital) Not yet recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Lori Stock         
Principal Investigator: Thom Dahle, MD         
United States, New York
NYU Grossman School of Medicine Not yet recruiting
New York, New York, United States, 10016
Contact: Research Coordinator       CathLabResCoordinators@nyulangone.org   
Principal Investigator: Craig Thompson, MD         
Icahn School of Medicine at Mt. Sinai Not yet recruiting
New York, New York, United States, 10029
Contact: Nicole Saint Vrestil         
Principal Investigator: Samin Sharma, MD         
Columbia University Medical Cenrer/NYPH Not yet recruiting
New York, New York, United States, 10032
Contact: Treena Williams         
Principal Investigator: Dimitrios Karmpaliotis, MD         
United States, Ohio
Linder Research Center (The Christ Hospital) Not yet recruiting
Cincinnati, Ohio, United States, 45219
Contact: Karen Heidrich         
Principal Investigator: Timothy Smith, MD         
Sponsors and Collaborators
Abiomed Inc.
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Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT04763200    
Other Study ID Numbers: VV-TMF-18508
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021

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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
Keywords provided by Abiomed Inc.:
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:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases