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The PEERLESS Study (PEERLESS)

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: NCT05111613
Recruitment Status : Recruiting
First Posted : November 8, 2021
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
Inari Medical

Brief Summary:
This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System compared to Catheter-Directed Thrombolysis (CDT) for acute intermediate-high-risk pulmonary embolism (PE), and includes a non-randomized cohort of up to 150 subjects with an absolute contraindication to thrombolytics.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Pulmonary Thrombo-embolism Device: Catheter-Directed Thrombolysis Device: FlowTriever System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The PEERLESS Study
Actual Study Start Date : February 14, 2022
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Randomized Controlled Trial Cohort - FlowTriever Arm
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
Device: FlowTriever System
Mechanical thrombectomy for pulmonary embolism

Active Comparator: Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
Device: Catheter-Directed Thrombolysis
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)

Non-Randomized Absolute Contraindication to Thrombolytics Cohort
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
Device: FlowTriever System
Mechanical thrombectomy for pulmonary embolism




Primary Outcome Measures :
  1. Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: [ Time Frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner ]
    1. All-cause mortality, or
    2. Intracranial hemorrhage (ICH), or
    3. Major bleeding per ISTH definition, or
    4. Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy, or
    5. ICU admission and ICU length-of-stay during the index hospitalization and following the index procedure.


Secondary Outcome Measures :
  1. Composite clinical endpoint constructed as a win ratio hierarchy of the following four components: [ Time Frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner ]
    • All-cause mortality, or
    • Intracranial hemorrhage (ICH), or
    • Major bleeding per ISTH definition, or
    • Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy

  2. All-cause mortality [ Time Frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner ]
  3. Intracranial hemorrhage (ICH) [ Time Frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner ]
  4. Major bleeding per ISTH definition [ Time Frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner ]
  5. Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy [ Time Frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner ]
  6. ICU admission and ICU length of stay during the index hospitalization and following the index procedure [ Time Frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner ]
  7. All cause mortality [ Time Frame: 30 days from index procedure ]
  8. PE-related and all-cause readmission [ Time Frame: 30 days from index procedure ]
  9. Device and drug-related serious adverse events [ Time Frame: 30 days from index procedure ]
  10. Clinically Relevant Non-Major (CRNM) and Minor bleeding events [ Time Frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner ]
  11. Change in right-ventricular/left-ventricular (RV/LV) ratio, as measured by echocardiography or CT [ Time Frame: Baseline to 24 hour visit ]
  12. Modified Medical Research Council (mMRC) dyspnea score [ Time Frame: At 24 hour and 30 day visits ]
    The range of scores is zero to four (worse)

  13. Length of total hospital stay and post-index-procedure hospital stay [ Time Frame: To a maximum of 30 days ]
  14. Pulmonary Embolism Quality of Life (PEmb-QOL) [ Time Frame: At 30 day visit ]
  15. EQ-5D-5L Quality of Life [ Time Frame: At 30 day visit ]


Information from the National Library of Medicine

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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

Subjects must meet each of the following criteria to be included in the study:

  • Age ≥ 18 years
  • Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary angiographic evidence of any proximal filling defect in at least one main or lobar pulmonary artery
  • Classification of intermediate-high-risk PE by ESC Guidelines 2019, including ALL of the following: clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI ≥1; AND hemodynamically stable; AND RV dysfunction on echocardiography or CT; AND elevated cardiac troponin levels
  • Intervention planned to begin within 72 hours of the later of either: confirmed PE diagnosis; OR if transferring from another hospital, arrival at the treating hospital
  • Symptom onset within 14 days of confirmed PE diagnosis

Exclusion Criteria

Subjects will be excluded from the study for any of the following criteria:

  • Unable to anticoagulate with heparin, enoxaparin or other parenteral antithrombin
  • Index presentation with hemodynamic instability that are part of the high-risk PE definition in the ESC Guidelines 2019, including ANY of the following: cardiac arrest; OR systolic BP < 90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite adequate filling status, AND end-organ hypoperfusion; OR 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
  • Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
  • 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)
  • Patient has right heart clot in transit identified at baseline screening
  • Life expectancy < 30 days (e.g. stage 4 cancer or severe COVID-19 infection), as determined by the Investigator
  • Current participation in another drug or device study that, in the Investigator's opinion, would interfere with participation in this study
  • Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis, per ESC 2019 guidelines
  • Invasive systolic PA pressure ≥70 mmHg prior to study device entering the body
  • Administration of bolus or drip/infusion thrombolytic therapy or mechanical thrombectomy for the index PE event within 48 hours prior to enrollment
  • Ventricular arrhythmias refractory to treatment at the time of enrollment
  • Known to have heparin-induced thrombocytopenia (HIT)
  • 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)
  • Subject has previously completed or withdrawn from this study
  • Patient unwilling or unable to conduct the follow up visits per protocol.

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): NCT05111613


Contacts
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Contact: Scott Skorupa 651-492-2654 scott.skorupa@inarimedical.com

Locations
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Sponsors and Collaborators
Inari Medical
Investigators
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Principal Investigator: Wissam Jaber, MD Emory University
Principal Investigator: Carin Gonsalves, MD Thomas Jefferson University
Principal Investigator: Stefan Stortecky, MD Bern University Hospital
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Responsible Party: Inari Medical
ClinicalTrials.gov Identifier: NCT05111613    
Other Study ID Numbers: 21-002
First Posted: November 8, 2021    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
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
Keywords provided by Inari Medical:
PE
pulmonary embolism
thrombectomy
FlowTriever
CDT
Catheter-Directed Thrombolysis
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases