The PEERLESS II Study

NCT06055920 | Recruiting FDA Device

• 1 other identifier: 23-001
• Study Type: interventional
• Target: 1,200
• Locations: 9 countries
• Sites: 83

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.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Composite clinical endpoint constructed as a win ratio, a hierarchy of the following, which are assessed post-randomization:

  * 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 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 * Change in Dyspnea, by mMRC from Baseline to the 48-hour visit

  through discharge or 30 days, whichever is sooner / dyspnea at 48 hours

Secondary Outcomes (12)

• Composite clinical endpoint constructed as a win ratio hierarchy of the following three components, assessed post randomization:

  up to 30 days

• All-cause and PE-related mortality

  At 30 and 90 days

• All-cause and PE-related readmissions

  At 30 and 90 days

• Clinical deterioration

  Through discharge or up to 30 days after randomization, whichever is sooner

• Bailout therapy

  Through discharge or up to 30 days after randomization, whichever is sooner

Study Arms (2)

FlowTriever

ACTIVE COMPARATOR

Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Device: FlowTriever System

Anticoagulation

ACTIVE COMPARATOR

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

Interventions

FlowTriever System DEVICE

Mechanical Thrombectomy for pulmonary embolism

FlowTriever

Anticoagulation Agents DRUG

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.

Anticoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at enrollment ≥ 18 years
• 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
• RV dysfunction, as defined as one or more of the following: RV/LV ratio ≥ 0.9 or RV dilation or hypokinesis
• 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
• Symptom onset within 14 days of confirmed PE diagnosis
• Willing and able to provide informed consent

You may not qualify if:

• Unable to be anticoagulated with heparin, enoxaparin or other parenteral antithrombin
• Presentation with hemodynamic instability\* that meets the high-risk PE definition in the 2019 ESC Guidelines1, 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 \* 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.
• 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)
• End stage medical condition with life expectancy \< 3 months, 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 2019 ESC Guidelines1
• 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
• 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
• 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). This includes a contraindication to use of FlowTriever System per local approved labeling

Sponsors & Collaborators

• Inari Medical: lead

Study Sites (83)

UAB Division of Cardiovascular Disease

Birmingham, Alabama, 35205, United States

RECRUITING

Brookwood Medical Center

Birmingham, Alabama, 35243, United States

COMPLETED

Huntington Memorial Hospital

Pasadena, California, 91105, United States

RECRUITING

University of Colorado, Denver

Aurora, Colorado, 80045, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

HCA FL Largo Medical Center

Largo, Florida, 33770, United States

ACTIVE NOT RECRUITING

AdventHealth Orlando

Orlando, Florida, 32803, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Baptist Health Louisville

Louisville, Kentucky, 40207, United States

WITHDRAWN

McLaren Greater Lansing

Lansing, Michigan, 48910, United States

RECRUITING

Metropolitan Heart & Vascular Institute

Coon Rapids, Minnesota, 55433, United States

WITHDRAWN

Mayo Clinic

Rochester, Minnesota, 55905, United States

WITHDRAWN

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

COMPLETED

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

RECRUITING

Nebraska Medical Center

Omaha, Nebraska, 68105, United States

RECRUITING

Virtua Health

Camden, New Jersey, 08103, United States

RECRUITING

Valley Health

Ridgewood, New Jersey, 07450, United States

WITHDRAWN

SUNY, The University of Buffalo/Gates Vascular

Buffalo, New York, 14203, United States

RECRUITING

Northwell Health

New York, New York, 10075, United States

RECRUITING

Jamaica Hospital

Queens, New York, 11418, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Ohio State University - Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

St. Luke's University Hospital

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

AHN Saint Vincent Hospital

Erie, Pennsylvania, 16505, United States

RECRUITING

UPMC Hamot

Erie, Pennsylvania, 16507, United States

RECRUITING

UPMC Harrisburg

Harrisburg, Pennsylvania, 17101, United States

RECRUITING

The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19144, United States

RECRUITING

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

UPMC Heart and Vascular Institute

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Wellspan York Hospital

York, Pennsylvania, 17403, United States

RECRUITING

HCA Tristar

Brentwood, Tennessee, 37027, United States

RECRUITING

UTMC Knoxville

Knoxville, Tennessee, 37920, United States

RECRUITING

Ascension Saint Thomas Hospital

Nashville, Tennessee, 37203, United States

RECRUITING

Parkland Hospital

Dallas, Texas, 75235, United States

RECRUITING

Texas Health Harris Methodist Hospital

Fort Worth, Texas, 76104, United States

RECRUITING

Methodist Main Hospital

San Antonio, Texas, 78229, United States

RECRUITING

Baylor Scott & White - Temple

Temple, Texas, 76508, United States

RECRUITING

Inova Fairfax

Falls Church, Virginia, 22042, United States

RECRUITING

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

Providence Sacred Heart

Spokane, Washington, 99204, United States

WITHDRAWN

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

RECRUITING

West Virginia University Ruby Memorial Hospital

Morgantown, West Virginia, 26506, United States

RECRUITING

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

RECRUITING

Onze Lieve Vrouwziekenhuis

Aalst, Belgium

RECRUITING

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

RECRUITING

Surrey Memorial Hospital

Surrey, British Columbia, V3V 1Z2, Canada

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

CHU Lille

Lille, France

RECRUITING

Hôpital Louis Pradel

Lyon, France

RECRUITING

AP-HM Hopital La Timone

Marseille, France

RECRUITING

Hôpital Nord Marseille

Marseille, France

RECRUITING

University Hospital Augsburg

Augsburg, Germany

RECRUITING

Universitäts-Herzzentrum Bad Krozingen

Bad Krozingen, Germany

RECRUITING

Charité Campus Virchow Clinic - Klinik fuer Radiologie

Berlin, Germany

RECRUITING

Unfall Krankenhaus Berlin

Berlin, Germany

RECRUITING

University Hospital Cologne

Cologne, Germany

RECRUITING

HerzZentrum Dresden Universitaetsklinik

Dresden, Germany

RECRUITING

Universitaetsklinikum Dὒsseldorf

Düsseldorf, Germany

RECRUITING

Elisabeth Hospital GmbH

Essen, Germany

RECRUITING

Universitaetsklinikum Essen

Essen, Germany

RECRUITING

CCB Frankfurt

Frankfurt, Germany

RECRUITING

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

RECRUITING

University Hospital - Heidelberg

Heidelberg, Germany

RECRUITING

Universitaetsklinikum Saarlandes Homburg

Homburg, Germany

WITHDRAWN

Westpfalz Klinikum

Kaiserslautern, Germany

RECRUITING

Klinikum rechts der Isar (TUM)

Munich, Germany

RECRUITING

Ludwig Maximilians-University

Munich, Germany

RECRUITING

University Hospital Regensburg

Regensburg, Germany

RECRUITING

Helios Kliniken Schwerin

Schwerin, Germany

RECRUITING

Schwarzwald-Baar-Klinikum

Villingen-Schwenningen, Germany

RECRUITING

John Paul II Hospital

Krakow, Poland

TERMINATED

Hopital Clinico Universitario San Carlos

Madrid, Spain

RECRUITING

Universitaetsspital Basel

Basel, Switzerland

RECRUITING

Universitätsspital Bern

Bern, Switzerland

RECRUITING

Luzerner Kantonsspital

Lucerne, Switzerland

RECRUITING

Related Publications (1)

• Giri J, Mahfoud F, Gebauer B, Andersen A, Friedman O, Gandhi RT, Jaber WA, Pereira K, West FM. PEERLESS II: A Randomized Controlled Trial of Large-Bore Thrombectomy Versus Anticoagulation in Intermediate-Risk Pulmonary Embolism. J Soc Cardiovasc Angiogr Interv. 2024 May 3;3(6):101982. doi: 10.1016/j.jscai.2024.101982. eCollection 2024 Jun.

  PMID: 39132600 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• 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

  Universitaetsspital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Gourley

CONTACT

580-400-2590; stephanie.gourley@inarimedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 28, 2023
• Study Start: November 17, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); US (50); FR (4); CA (3); ES (1); CH (3); DE (19); PL (1); BE (1)