Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1200 participants
INTERVENTIONAL
2023-11-17
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FlowTriever
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
FlowTriever System
Mechanical Thrombectomy for pulmonary embolism
Anticoagulation
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 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.
Interventions
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FlowTriever System
Mechanical Thrombectomy for pulmonary embolism
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Inari Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Frances Mae West, MD
Role: PRINCIPAL_INVESTIGATOR
Jefferson Health
Jay Giri, MD
Role: PRINCIPAL_INVESTIGATOR
Penn Medicine
Bernhard Gebauer, MD
Role: PRINCIPAL_INVESTIGATOR
Charité University Hospital Berlin
Felix Mahfoud, MD
Role: PRINCIPAL_INVESTIGATOR
Universitaetsspital Basel
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Samuel McElwee, MD
Role: primary
Nikhil Daga, MD
Role: primary
Peter Hountras, MD
Role: primary
Akhil Khosla, MD
Role: primary
Jesse J Klein, DO
Role: primary
Barry Weinstock, MD
Role: primary
Wissam Jaber, MD
Role: primary
Daniel Schimmel, MD
Role: primary
Ibrahim Shah, MD
Role: primary
Jennifer Buckley, MD
Role: primary
Madhu Kalyan Pendurthi, MD
Role: primary
Jason Cook, MD
Role: primary
Rita Butler, MD
Role: primary
David Zlotnick, MD
Role: primary
Bushra Mina, MD
Role: primary
Zoran Lasic, MD
Role: primary
Jeffrey Bruckel, MD
Role: primary
Daniel Ohngemach, MD
Role: primary
Asma Khaliq, MD
Role: primary
Rishi Sukhija, MD
Role: primary
Aravinda Nanjundappa, MD
Role: primary
Richard Gumina, MD
Role: primary
Neal Fitzpatrick, MD
Role: primary
Orestis Pappas, MD
Role: primary
Robert Maholic, DO
Role: primary
Torrey Schmidt, DO
Role: primary
Sameer Khandhar, MD
Role: primary
Mae West, MD
Role: primary
Mithun Chakravarthy
Role: primary
Catalin Toma, MD
Role: primary
Paul Tolerico, MD
Role: primary
Sam Horr, MD
Role: primary
Chris Walker, MD
Role: primary
Jimmy Kerrigan, MD
Role: primary
Akram Sadeghi, MD
Role: primary
John Hollingsworth, MD
Role: primary
Chandra Kunavarapu, MD
Role: primary
Jeffrey DellaVolpe, MD
Role: backup
Tasnim Lat, DO
Role: primary
Jonathan Keung, MD
Role: primary
David Dexter, MD
Role: primary
Matthew Abad-Santos, MD
Role: primary
Shadi Abu-Halimah, MD
Role: primary
Sunil Sharma, MD
Role: primary
Khawaja Afzal Ammar, MD
Role: primary
Marc Vanderheyden, MD
Role: primary
Zameer Hirji, MD
Role: primary
Behrang Homayoon
Role: primary
Gordon Finlayson, MD
Role: primary
Asger Andersen, MD, PhD
Role: primary
Gilles Lemesle, Prof. Dr. med.
Role: primary
Salim Si-Mohamed, Prof. Dr. med.
Role: primary
Thomas Cuisset, MD
Role: primary
Marc Laine, Dr. med.
Role: primary
Christian Scheurig-Mὒnkler, Dr.
Role: primary
Elias Noory, Dr. med.
Role: primary
Bernhard Gebauer, Prof. Dr. med.
Role: primary
Rainer Wasielewski, Dr. med.
Role: primary
Stephan Rosenkranz, Prof.
Role: primary
Norman Mangner, Prof. Dr. med.
Role: primary
Hans Lucas Busch, Dr. med.
Role: primary
Moaaz Elsharabassy, Dr.
Role: primary
Christos Rammos, Prof. Dr. med.
Role: primary
Michael Piorkowski, Dr. med.
Role: primary
Fabian Brunner, Prof Dr. Med
Role: primary
Richard Schell, Dr.
Role: primary
Burghard Schumacher, Prof.
Role: primary
Tareq Ibrahim, Prof. Dr.
Role: primary
Konstantin Stark, Prof.
Role: primary
Stefan Stadler, Prof. Dr. med.
Role: primary
Philipp Hammer, Dr. med.
Role: primary
Sebastian Ewen, Prof Dr. Med
Role: primary
Grzegorz Kopeć, Prof. Med.
Role: primary
Pablo Salinas, Dr. med.
Role: primary
Gregor Leibundgut, Dr. med.
Role: primary
Stefan Stortecky, Prof. Dr. med
Role: primary
Thorsten Grumann, Dr. med.
Role: primary
References
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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.
Other Identifiers
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23-001
Identifier Type: -
Identifier Source: org_study_id
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