Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

Memorial Hermann Medical Center
Houston, Texas 77030

More Details

Status
Recruiting
Sponsor
Inari Medical

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.