Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06055920

The PEERLESS II Study

Led by Inari Medical · Updated on 2026-05-06

1200

Participants Needed

83

Research Sites

136 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

The PEERLESS II Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Confirmed proximal pulmonary embolism in at least one main or lobar pulmonary artery by imaging
  • Evidence of right ventricular dysfunction, such as RV/LV ratio 2 0.9, RV dilation, or reduced motion
  • Presence of at least two additional risk factors from hemodynamic, biomarker, or respiratory categories
  • Symptom onset within 14 days of pulmonary embolism diagnosis
  • Ability and willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Unable to receive anticoagulation with heparin, enoxaparin, or other parenteral antithrombin
  • Hemodynamic instability meeting high-risk PE criteria, including cardiac arrest or low blood pressure with organ hypoperfusion
  • Known allergy to contrast agents that cannot be treated
  • Unsuitable for catheter intervention due to clot location or chronic clotting issues
  • Life expectancy less than 3 months due to end-stage medical condition
  • Participation in another drug or device study that might interfere
  • History or current diagnosis of chronic thromboembolic pulmonary hypertension or disease
  • Estimated right ventricular systolic pressure over 70 mmHg if tested
  • Received advanced therapies for pulmonary embolism within 30 days prior to enrollment
  • Uncontrolled ventricular arrhythmias at enrollment
  • Known heparin-induced thrombocytopenia
  • Any condition that would make participation unsafe or interfere with assessments
  • Pregnancy
  • Previous completion or withdrawal from this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 83 locations

1

UAB Division of Cardiovascular Disease

Birmingham, Alabama, United States, 35205

Actively Recruiting

2

Brookwood Medical Center

Birmingham, Alabama, United States, 35243

Completed

3

Huntington Memorial Hospital

Pasadena, California, United States, 91105

Actively Recruiting

4

University of Colorado, Denver

Aurora, Colorado, United States, 80045

Actively Recruiting

5

Yale University

New Haven, Connecticut, United States, 06520

Actively Recruiting

6

HCA FL Largo Medical Center

Largo, Florida, United States, 33770

Active, Not Recruiting

7

AdventHealth Orlando

Orlando, Florida, United States, 32803

Actively Recruiting

8

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

9

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

10

Baptist Health Louisville

Louisville, Kentucky, United States, 40207

Withdrawn

11

McLaren Greater Lansing

Lansing, Michigan, United States, 48910

Actively Recruiting

12

Metropolitan Heart & Vascular Institute

Coon Rapids, Minnesota, United States, 55433

Withdrawn

13

Mayo Clinic

Rochester, Minnesota, United States, 55905

Withdrawn

14

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States, 64111

Completed

15

Mercy Hospital Springfield

Springfield, Missouri, United States, 65804

Actively Recruiting

16

Nebraska Medical Center

Omaha, Nebraska, United States, 68105

Actively Recruiting

17

Virtua Health

Camden, New Jersey, United States, 08103

Actively Recruiting

18

Valley Health

Ridgewood, New Jersey, United States, 07450

Withdrawn

19

SUNY, The University of Buffalo/Gates Vascular

Buffalo, New York, United States, 14203

Actively Recruiting

20

Northwell Health

New York, New York, United States, 10075

Actively Recruiting

21

Jamaica Hospital

Queens, New York, United States, 11418

Actively Recruiting

22

University of Rochester Medical Center

Rochester, New York, United States, 14642

Actively Recruiting

23

Stony Brook University Hospital

Stony Brook, New York, United States, 11794

Actively Recruiting

24

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

25

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

Actively Recruiting

26

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

27

Ohio State University - Wexner Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

28

St. Luke's University Hospital

Bethlehem, Pennsylvania, United States, 18015

Actively Recruiting

29

AHN Saint Vincent Hospital

Erie, Pennsylvania, United States, 16505

Actively Recruiting

30

UPMC Hamot

Erie, Pennsylvania, United States, 16507

Actively Recruiting

31

UPMC Harrisburg

Harrisburg, Pennsylvania, United States, 17101

Actively Recruiting

32

The University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

33

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19144

Actively Recruiting

34

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

35

UPMC Heart and Vascular Institute

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

36

Wellspan York Hospital

York, Pennsylvania, United States, 17403

Actively Recruiting

37

HCA Tristar

Brentwood, Tennessee, United States, 37027

Actively Recruiting

38

UTMC Knoxville

Knoxville, Tennessee, United States, 37920

Actively Recruiting

39

Ascension Saint Thomas Hospital

Nashville, Tennessee, United States, 37203

Actively Recruiting

40

Parkland Hospital

Dallas, Texas, United States, 75235

Actively Recruiting

41

Texas Health Harris Methodist Hospital

Fort Worth, Texas, United States, 76104

Actively Recruiting

42

Methodist Main Hospital

San Antonio, Texas, United States, 78229

Actively Recruiting

43

Baylor Scott & White - Temple

Temple, Texas, United States, 76508

Actively Recruiting

44

Inova Fairfax

Falls Church, Virginia, United States, 22042

Actively Recruiting

45

Sentara Vascular Specialists

Norfolk, Virginia, United States, 23507

Actively Recruiting

46

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

47

Providence Sacred Heart

Spokane, Washington, United States, 99204

Withdrawn

48

Charleston Area Medical Center

Charleston, West Virginia, United States, 25304

Actively Recruiting

49

West Virginia University Ruby Memorial Hospital

Morgantown, West Virginia, United States, 26506

Actively Recruiting

50

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States, 53215

Actively Recruiting

51

Onze Lieve Vrouwziekenhuis

Aalst, Belgium

Actively Recruiting

52

Royal Columbian Hospital

New Westminster, British Columbia, Canada, V3L 3W7

Actively Recruiting

53

Surrey Memorial Hospital

Surrey, British Columbia, Canada, V3V 1Z2

Actively Recruiting

54

Vancouver General Hospital

Vancouver, British Columbia, Canada, V5Z 1M9

Actively Recruiting

55

Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

56

CHU Lille

Lille, France

Actively Recruiting

57

Hôpital Louis Pradel

Lyon, France

Actively Recruiting

58

AP-HM Hopital La Timone

Marseille, France

Actively Recruiting

59

Hôpital Nord Marseille

Marseille, France

Actively Recruiting

60

University Hospital Augsburg

Augsburg, Germany

Actively Recruiting

61

Universitäts-Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Actively Recruiting

62

Charité Campus Virchow Clinic - Klinik fuer Radiologie

Berlin, Germany

Actively Recruiting

63

Unfall Krankenhaus Berlin

Berlin, Germany

Actively Recruiting

64

University Hospital Cologne

Cologne, Germany

Actively Recruiting

65

HerzZentrum Dresden Universitaetsklinik

Dresden, Germany

Actively Recruiting

66

Universitaetsklinikum Dὒsseldorf

Düsseldorf, Germany

Actively Recruiting

67

Elisabeth Hospital GmbH

Essen, Germany

Actively Recruiting

68

Universitaetsklinikum Essen

Essen, Germany

Actively Recruiting

69

CCB Frankfurt

Frankfurt, Germany

Actively Recruiting

70

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

Actively Recruiting

71

University Hospital - Heidelberg

Heidelberg, Germany

Actively Recruiting

72

Universitaetsklinikum Saarlandes Homburg

Homburg, Germany

Withdrawn

73

Westpfalz Klinikum

Kaiserslautern, Germany

Actively Recruiting

74

Klinikum rechts der Isar (TUM)

Munich, Germany

Actively Recruiting

75

Ludwig Maximilians-University

Munich, Germany

Actively Recruiting

76

University Hospital Regensburg

Regensburg, Germany

Actively Recruiting

77

Helios Kliniken Schwerin

Schwerin, Germany

Actively Recruiting

78

Schwarzwald-Baar-Klinikum

Villingen-Schwenningen, Germany

Actively Recruiting

79

John Paul II Hospital

Krakow, Poland

Terminated

80

Hopital Clinico Universitario San Carlos

Madrid, Spain

Actively Recruiting

81

Universitaetsspital Basel

Basel, Switzerland

Actively Recruiting

82

Universitätsspital Bern

Bern, Switzerland

Actively Recruiting

83

Luzerner Kantonsspital

Lucerne, Switzerland

Actively Recruiting

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Research Team

S

Stephanie Gourley

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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