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Pulmonary EmbolismNCT06055920

The PEERLESS II Study

A study testing FlowTriever System and Anticoagulation Agents in people with Pulmonary Embolism, run by Inari Medical at 72 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism
What is being tested?
FlowTriever System and Anticoagulation Agents
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
72 sitesin 8 countries
Study dates
17 Nov 2023to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • Subject is currently pregnant
  • Subject has previously completed or withdrawn from this study

Trial locations and contacts

72 sites in 8 countries.

72 sites in 8 countries

United States42 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado, Denver

    Aurora, Colorado, 80045

  • St. Luke's University Hospital

    Bethlehem, Pennsylvania, 18015

  • UAB Division of Cardiovascular Disease

    Birmingham, Alabama, 35205

  • Brookwood Medical Center

    Birmingham, Alabama, 35243

  • HCA Tristar

    Brentwood, Tennessee, 37027

  • SUNY, The University of Buffalo/Gates Vascular

    Buffalo, New York, 14203

  • Virtua Health

    Camden, New Jersey, 08103

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University - Wexner Medical Center

    Columbus, Ohio, 43210

  • Parkland Hospital

    Dallas, Texas, 75235

  • AHN Saint Vincent Hospital

    Erie, Pennsylvania, 16505

  • UPMC Hamot

    Erie, Pennsylvania, 16507

  • Inova Fairfax

    Falls Church, Virginia, 22042

  • Texas Health Harris Methodist Hospital

    Fort Worth, Texas, 76104

  • UPMC Harrisburg

    Harrisburg, Pennsylvania, 17101

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • UTMC Knoxville

    Knoxville, Tennessee, 37920

  • McLaren Greater Lansing

    Lansing, Michigan, 48910

  • HCA FL Largo Medical Center

    Largo, Florida, 33770

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • West Virginia University Ruby Memorial Hospital

    Morgantown, West Virginia, 26506

  • Ascension Saint Thomas Hospital

    Nashville, Tennessee, 37203

  • Yale University

    New Haven, Connecticut, 06520

  • Northwell Health

    New York, New York, 10075

  • Nebraska Medical Center

    Omaha, Nebraska, 68105

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Huntington Memorial Hospital

    Pasadena, California, 91105

  • The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19144

  • Allegheny Health Network Research Institute

    Pittsburgh, Pennsylvania, 15212

  • UPMC Heart and Vascular Institute

    Pittsburgh, Pennsylvania, 15213

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Methodist Main Hospital

    San Antonio, Texas, 78229

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Baylor Scott & White - Temple

    Temple, Texas, 76508

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Wellspan York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Germany17 sites

  • University Hospital Augsburg

    Augsburg

  • Universitäts-Herzzentrum Bad Krozingen

    Bad Krozingen

  • Charité Campus Virchow Clinic - Klinik fuer Radiologie

    Berlin

  • Unfall Krankenhaus Berlin

    Berlin

  • University Hospital Cologne

    Cologne

  • HerzZentrum Dresden Universitaetsklinik

    Dresden

  • Universitaetsklinikum Dὒsseldorf

    Düsseldorf

  • Elisabeth Hospital GmbH

    Essen

  • Universitaetsklinikum Essen

    Essen

  • CCB Frankfurt

    Frankfurt

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg

  • University Hospital - Heidelberg

    Heidelberg

  • Westpfalz Klinikum

    Kaiserslautern

  • Klinikum rechts der Isar (TUM)

    Munich

  • Ludwig Maximilians-University

    Munich

  • University Hospital Regensburg

    Regensburg

  • Schwarzwald-Baar-Klinikum

    Villingen-Schwenningen

Other trials in Germany

France4 sites

  • CHU Lille

    Lille

  • Hôpital Louis Pradel

    Lyon

  • AP-HM Hopital La Timone

    Marseille

  • Hôpital Nord Marseille

    Marseille

Other trials in France

Canada3 sites

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W7

  • Surrey Memorial Hospital

    Surrey, British Columbia, V3V 1Z2

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Switzerland3 sites

  • Universitaetsspital Basel

    Basel

  • Universitätsspital Bern

    Bern

  • Luzerner Kantonsspital

    Lucerne

Other trials in Switzerland

Belgium1 site

  • Onze Lieve Vrouwziekenhuis

    Aalst

Other trials in Belgium

Denmark1 site

  • Aarhus University Hospital

    Aarhus, 8200

Other trials in Denmark

Spain1 site

  • Hopital Clinico Universitario San Carlos

    Madrid

Other trials in Spain

About this study

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

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

Being tested
FlowTriever System, Anticoagulation Agents
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FlowTriever SystemDevice

    Mechanical Thrombectomy for pulmonary embolism

  • Anticoagulation AgentsDrug

    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.

Study groups in NCT06055920
Study groupRoleWhat they receive
FlowTrieverActive comparatorMechanical thrombectomy for pulmonary embolism using the FlowTriever System.
Receives: Device: FlowTriever System
AnticoagulationActive comparatorCommercially 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.
Receives: Drug: Anticoagulation Agents

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (12)

  1. Composite clinical endpoint constructed as a win ratio hierarchy of the following three components, 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 readmission, by 30 days

    Measured: up to 30 days

  2. All-cause and PE-related mortality

    Measured: At 30 and 90 days

  3. All-cause and PE-related readmissions

    Measured: At 30 and 90 days

  4. Clinical deterioration

    defined by hemodynamic or respiratory worsening

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

  5. Bailout therapy

    either after a deterioration or after documented failure to progress,

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

  6. Major Bleeding, defined by the Bleeding Academic Research Consortium (BARC), level 3b, 3c, 5a, or 5b

    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

    Measured: At 30 and 90 days

  7. Dyspnea severity by mMRC score

    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

    Measured: At the 48-hour, 1-month, and 3-month visits

  8. PE-related quality of life, by PEmb-QoL

    Pulmonary Embolism Quality of Life: (higher = better)

    Measured: At the 1- and 3-month visits

  9. General health-related quality of life, by EQ-5D-5L

    Higher score = worse

    Measured: At the 1- and 3-month visits

  10. 6-minute walk distance

    Measured: At the 1-month visit

  11. RV/LV ratio

    Measured: At the 48-hour visit

  12. Post-PE Impairment diagnosis (PPEI)

    Measured: Through the 3-month visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start17 Nov 2023
  3. Primary completion30 Jul 2026
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06055920
Sponsor's protocol ID
23-001
Status last verified
Oct 2026
First submitted
15 Sep 2023
Last updated
8 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 39132600

Questions about this trial

What is this clinical trial studying?

A study testing FlowTriever System and Anticoagulation Agents in people with Pulmonary Embolism, run by Inari Medical at 72 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Germany, France, Canada, Switzerland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06055920, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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