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RECRUITING

NCT06055920

The PEERLESS II Study

Sponsor: Inari Medical

View on ClinicalTrials.gov

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.

Official title: PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2023-11-17

Completion Date

2026-07

Last Updated

2026-04-06

Healthy Volunteers

Conditions

Pulmonary Embolism

Interventions

DEVICE

FlowTriever System

Mechanical Thrombectomy for pulmonary embolism

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.

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

Locations (83)

UAB Division of Cardiovascular Disease

Birmingham, Alabama, United States

Brookwood Medical Center

Birmingham, Alabama, United States

Huntington Memorial Hospital

Pasadena, California, United States

University of Colorado, Denver

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

HCA FL Largo Medical Center

Largo, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Baptist Health Louisville

Louisville, Kentucky, United States

McLaren Greater Lansing

Lansing, Michigan, United States

Metropolitan Heart & Vascular Institute

Coon Rapids, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Nebraska Medical Center

Omaha, Nebraska, United States

Virtua Health

Camden, New Jersey, United States

Valley Health

Ridgewood, New Jersey, United States

SUNY, The University of Buffalo/Gates Vascular

Buffalo, New York, United States

Northwell Health

New York, New York, United States

Jamaica Hospital

Queens, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University - Wexner Medical Center

Columbus, Ohio, United States

St. Luke's University Hospital

Bethlehem, Pennsylvania, United States

AHN Saint Vincent Hospital

Erie, Pennsylvania, United States

UPMC Hamot

Erie, Pennsylvania, United States

UPMC Harrisburg

Harrisburg, Pennsylvania, United States

The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania, United States

UPMC Heart and Vascular Institute

Pittsburgh, Pennsylvania, United States

Wellspan York Hospital

York, Pennsylvania, United States

HCA Tristar

Brentwood, Tennessee, United States

UTMC Knoxville

Knoxville, Tennessee, United States

Ascension Saint Thomas Hospital

Nashville, Tennessee, United States

Parkland Hospital

Dallas, Texas, United States

Texas Health Harris Methodist Hospital

Fort Worth, Texas, United States

Methodist Main Hospital

San Antonio, Texas, United States

Baylor Scott & White - Temple

Temple, Texas, United States

Inova Fairfax

Falls Church, Virginia, United States

Sentara Vascular Specialists

Norfolk, Virginia, United States

University of Washington

Seattle, Washington, United States

Providence Sacred Heart

Spokane, Washington, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

West Virginia University Ruby Memorial Hospital

Morgantown, West Virginia, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Onze Lieve Vrouwziekenhuis

Aalst, Belgium

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Surrey Memorial Hospital

Surrey, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Aarhus University Hospital

Aarhus, Denmark

CHU Lille

Lille, France

Hôpital Louis Pradel

Lyon, France

AP-HM Hopital La Timone

Marseille, France

Hôpital Nord Marseille

Marseille, France

University Hospital Augsburg

Augsburg, Germany

Universitäts-Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Charité Campus Virchow Clinic - Klinik fuer Radiologie

Berlin, Germany

Unfall Krankenhaus Berlin

Berlin, Germany

University Hospital Cologne

Cologne, Germany

HerzZentrum Dresden Universitaetsklinik

Dresden, Germany

Universitaetsklinikum Dὒsseldorf

Düsseldorf, Germany

Elisabeth Hospital GmbH

Essen, Germany

Universitaetsklinikum Essen

Essen, Germany

CCB Frankfurt

Frankfurt, Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

University Hospital - Heidelberg

Heidelberg, Germany

Universitaetsklinikum Saarlandes Homburg

Homburg, Germany

Westpfalz Klinikum

Kaiserslautern, Germany

Klinikum rechts der Isar (TUM)

Munich, Germany

Ludwig Maximilians-University

Munich, Germany

University Hospital Regensburg

Regensburg, Germany

Helios Kliniken Schwerin

Schwerin, Germany

Schwarzwald-Baar-Klinikum

Villingen-Schwenningen, Germany

John Paul II Hospital

Krakow, Poland

Hopital Clinico Universitario San Carlos

Madrid, Spain

Universitaetsspital Basel

Basel, Switzerland

Universitätsspital Bern

Bern, Switzerland

Luzerner Kantonsspital

Lucerne, Switzerland