PEERLESS II: A Randomized Controlled Trial of Large-Bore Thrombectomy Versus Anticoagulation in Intermediate-Risk Pulmonary Embolism.
Jay Giri, Felix Mahfoud, Bernhard Gebauer...
https://pubmed.ncbi.nlm.nih.gov/39132600Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06055920
PEERLESS II: Randomized Trial of FlowTriever System versus Anticoagulation Alone for Intermediate-Risk Pulmonary Embolism
Led by Inari Medical · Updated on 2026-06-02
1200
Participants Needed
83
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the FlowTriever System combined with anticoagulation medication compared to anticoagulation medication alone in treating intermediate-risk acute pulmonary embolism (PE). This multicenter, randomized controlled trial aims to better understand the clinical outcomes of these treatment approaches in adults with PE who have specific heart and lung risk factors. Participants receive either mechanical thrombectomy using the FlowTriever System or anticoagulation drugs such as Heparin Sodium, Coumadin, Rivaroxaban, or Apixaban. The study compares these two methods to see how they affect recovery and complications. Treatments are given as per standard practice, with patients randomized to one of the two groups. During the study, participants will be monitored for clinical outcomes including breathing difficulty 48 hours after treatment, mortality, hospital readmission, bleeding events, and quality of life up to three months. Various assessments such as 6-minute walk tests, heart imaging, and questionnaires on symptoms and health quality are performed. The study tracks these results through discharge and follow-up visits to 90 days, with total participation lasting several months.
CONDITIONS
Brief Title
The PEERLESS II Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed pulmonary embolism with blockage in a main or lobar pulmonary artery by imaging
- Evidence of right ventricular dysfunction or enlargement
- At least two additional risk factors such as low blood pressure (90-100 mmHg), heart rate over 100 bpm, elevated heart biomarkers, low oxygen saturation, or respiratory symptoms
- Symptom onset within 14 days of PE diagnosis
- Able and willing to provide informed consent
You will not qualify if you...
- Unable to receive anticoagulation with heparin, enoxaparin, or similar drugs
- Hemodynamic instability defined as cardiac arrest, very low blood pressure, or need for vasopressors with organ hypoperfusion
- Known allergy to contrast agents that cannot be treated
- Unsuitable for catheter-based intervention due to clot location or chronic clot
- End-stage illness with life expectancy under 3 months
- Participation in another interfering drug or device study
- History or presence of chronic thromboembolic pulmonary hypertension or disease
- High right ventricular systolic pressure above 70 mmHg if suspected
- Prior advanced therapies for current PE within 30 days
- Uncontrolled ventricular arrhythmias
- Known heparin-induced thrombocytopenia
- Any condition making participation unsafe or unsuitable
- Currently pregnant
- Previous participation or withdrawal from this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Through discharge or up to 30 days after randomization, whichever is sooner
Participants receive mechanical thrombectomy for pulmonary embolism using the FlowTriever System or anticoagulation medication.
1 baseline visit and multiple visits through discharge or up to 30 days
Follow-up
Duration - Up to 90 days after randomization
Participants are monitored for clinical outcomes including mortality, readmissions, bleeding events, symptom severity, and quality of life after treatment ends.
Visits at 48 hours, 1 month, and 3 months
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
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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