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The PEERLESS II Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06055920
Recruitment Status : Recruiting
First Posted : September 28, 2023
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
Inari Medical

Study Description
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Brief Summary:
This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute PE.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Device: FlowTriever System Drug: Anticoagulation Agents Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism
Actual Study Start Date : November 17, 2023
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: FlowTriever
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
 Device: FlowTriever System
Mechanical Thrombectomy for pulmonary embolism
Active Comparator: Anticoagulation

Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.

Anticoagulants are a group of medications that decrease your blood's ability to clot.

 Drug: Anticoagulation Agents

Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.

Anticoagulants are a group of medications that decrease your blood's ability to clot.


Outcome Measures
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Primary Outcome Measures :
  1. Composite clinical endpoint constructed as a win ratio, a hierarchy of the following, which are assessed post-randomization: [ Time Frame: through discharge or 30 days, whichever is sooner / dyspnea at 48 hours ]
    • Clinical deterioration, defined by hemodynamic or respiratory worsening, through discharge or up to 30 days after randomization, whichever is sooner, or
    • All-cause hospital re-admission by 30 days, or
    • Bailout therapy, either after a deterioration or after documented failure to progress, through discharge or up to 30 days after randomization, whichever is sooner, or
    • Dyspnea, by mMRC at the 48-hour visit


Secondary Outcome Measures :
  1. Composite clinical endpoint constructed as a win ratio hierarchy of the following three components, assessed post randomization: [ Time Frame: up to 30 days ]
    • All-cause mortality, by 30 days, or
    • Clinical deterioration defined by hemodynamic or respiratory worsening, through discharge or up to 30 days after randomization, whichever is sooner, or
    • All-cause readmission, by 30 days

  2. All-cause and PE-related mortality [ Time Frame: At 30 and 90 days ]
  3. All-cause and PE-related readmissions [ Time Frame: At 30 and 90 days ]
  4. Clinical deterioration [ Time Frame: Through discharge or up to 30 days after randomization, whichever is sooner ]
    defined by hemodynamic or respiratory worsening

  5. Bailout therapy [ Time Frame: Through discharge or up to 30 days after randomization, whichever is sooner ]
    either after a deterioration or after documented failure to progress,

  6. Major Bleeding, defined by the Bleeding Academic Research Consortium (BARC), level 3b, 3c, 5a, or 5b [ Time Frame: At 30 and 90 days ]

    3b: Overt bleeding plus hemoglobin drop of ≥ 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade, bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid); bleeding requiring intravenous vasoactive agents 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), subcategories confirmed by autopsy or imaging or lumbar puncture, intraocular bleed compromising vision.

    5a: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious 5b: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation


  7. Dyspnea severity by mMRC score [ Time Frame: At the 48-hour, 1-month, and 3-month visits ]

    0, no breathlessness except on strenuous exercise;

    • 1, shortness of breath when hurrying on the level or walking up a slight hill;
    • 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level;
    • 3, stops for breath after walking ∼100 m or after few minutes on the level; and
    • 4, too breathless to leave the house, or breathless when dressing or undressing

  8. PE-related quality of life, by PEmb-QoL [ Time Frame: At the 1- and 3-month visits ]
    Pulmonary Embolism Quality of Life: (higher = better)

  9. General health-related quality of life, by EQ-5D-5L [ Time Frame: At the 1- and 3-month visits ]
    Higher score = worse

  10. 6-minute walk distance [ Time Frame: At the 1-month visit ]
  11. RV/LV ratio [ Time Frame: At the 48-hour visit ]
  12. Post-PE Impairment diagnosis (PPEI) [ Time Frame: Through the 3-month visit ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age at enrollment ≥ 18 years
  2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery, as confirmed by CTPA, pulmonary angiography, or other imaging modality
  3. RV dysfunction, as defined as one or more of the following: RV/LV ratio ≥ 0.9 or RV dilation or hypokinesis

  4. At least two additional risk factors, identified by at least one measure in two separate categories noted below:

    a. Hemodynamic: i. SBP 90-100mmHg ii. Resting heart rate > 100 bpm b. Biomarker: i. Elevated* cardiac troponin (troponin I or troponin T, conventional or high sensitivity) ii. Elevated* BNP or NT-proBNP iii. Elevated venous lactate ≥2 mmol/L * Elevated, meaning at or above the upper limit of normal, per local standards for the assay used c. Respiratory: i. O2 saturation < 90% on room air ii. Supplemental O2 requirement ≥ 4 L/min iii. Respiratory rate ≥ 20 breaths/min iv. mMRC score > 0

  5. Symptom onset within 14 days of confirmed PE diagnosis
  6. Willing and able to provide informed consent

Exclusion Criteria:

  1. Unable to be anticoagulated with heparin, enoxaparin or other parenteral antithrombin

  2. Presentation with hemodynamic instability* that meets the high-risk PE definition in the 2019 ESC Guidelines1, including ANY of the following

    1. Cardiac arrest OR
    2. Systolic BP < 90 mmHg or vasopressors required to achieve a BP ≥ 90 mmHg despite adequate filling status, AND end-organ hypoperfusion OR
    3. Systolic BP < 90 mmHg or systolic BP drop ≥ 40 mmHg, lasting longer than 15 min and not caused by new-onset arrhythmia, hypovolemia, or sepsis * Patients who are stable at time of screening or randomization (i.e., SBP ≥ 90 mmHg and adequate organ perfusion without catecholamine or vasopressor infusion) may be included despite initial presentation including temporary, low-dose catecholamines or vasopressors, or temporary fluid resuscitation.
  3. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
  4. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention (e.g., inability to navigate to target location, clot limited to segmental/subsegmental distribution, predominately chronic clot)
  5. End stage medical condition with life expectancy < 3 months, as determined by the Investigator
  6. Current participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this study
  7. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis, per 2019 ESC Guidelines1
  8. If objective testing was performed*, estimated RV systolic pressure > 70 mmHg on standard of care echocardiography * If clinical suspicion of acute-on-chronic PE, chronic obstruction, or chronic thromboembolism, echocardiographic estimated RVSP must be confirmed ≤70 mmHg to meet eligibility. Pressure assessment not required if Investigator attests to absence of such clinical suspicion
  9. Administration of advanced therapies (thrombolytic bolus, thrombolytic drip/infusion, catheter-directed thrombolytic therapy, mechanical thrombectomy, or ECMO) for the index PE event within 30 days prior to enrollment
  10. Ventricular arrhythmias refractory to treatment at the time of enrollment
  11. Known to have heparin-induced thrombocytopenia (HIT)
  12. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments). This includes a contraindication to use of FlowTriever System per local approved labeling
  13. Subject is currently pregnant
  14. Subject has previously completed or withdrawn from this study
Contacts and Locations
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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): NCT06055920


Contacts
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Contact: Cassandra Gamble 651-900-5294 cassandra.gamble@inarimedical.com

Locations
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Sponsors and Collaborators
Inari Medical
Investigators
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Principal Investigator: Frances Mae West, MD Jefferson Health,
Principal Investigator: Jay Giri, MD Penn Medicine
Principal Investigator: Bernhard Gebauer, MD Charité University Hospital Berlin
Principal Investigator: Felix Mahfoud, MD Saarland University Hospital Homburg
More Information
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Responsible Party: Inari Medical
ClinicalTrials.gov Identifier: NCT06055920    
Other Study ID Numbers: 23-001
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Anticoagulants