Study Results
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View full resultsBasic Information
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COMPLETED
NA
692 participants
INTERVENTIONAL
2022-02-14
2024-04-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Randomized Controlled Trial Cohort - FlowTriever Arm
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
FlowTriever System
Mechanical thrombectomy for pulmonary embolism
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
Catheter-Directed Thrombolysis
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
FlowTriever System
Mechanical thrombectomy for pulmonary embolism
Interventions
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Catheter-Directed Thrombolysis
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
FlowTriever System
Mechanical thrombectomy for pulmonary embolism
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary angiographic evidence of any proximal filling defect in at least one main or lobar pulmonary artery
* Including ALL of the following: Clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI ≥1; AND Hemodynamically stable AND; RV dysfunction on echocardiography or CT; AND Any one or more of the following present at the time of diagnosis: Elevated cardiac troponin levels; History of heart failure; History of chronic lung disease; Heart rate ≥110 beats per minute; SBP \<100mmHg; Respiratory rate ≥30 breaths per minute; O2 saturation \<90%; Syncope related to PE; Elevated Lactate
* Intervention planned to begin within 72 hours of the later of either: confirmed PE diagnosis; OR if transferring from another hospital, arrival at the treating hospital
* Symptom onset within 14 days of confirmed PE diagnosis
Exclusion Criteria
* Unable to anticoagulate with heparin, enoxaparin or other parenteral antithrombin
* Index presentation with hemodynamic instability that are part of the high-risk PE definition in the ESC Guidelines 2019, 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
* 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)
* Patient has right heart clot in transit identified at baseline screening
* Life expectancy \< 30 days (e.g. stage 4 cancer or severe COVID-19 infection), 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 ESC 2019 guidelines
* Invasive systolic PA pressure ≥70 mmHg prior to study device entering the body
* Administration of bolus or drip/infusion thrombolytic therapy or mechanical thrombectomy for the index PE event within 48 hours 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 or CDT System (for example, EKOS System) per local approved labeling
* Subject has previously completed or withdrawn from this study
* Patient unwilling or unable to conduct the follow up visits per protocol.
18 Years
ALL
No
Sponsors
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Inari Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Wissam Jaber, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Carin Gonsalves, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Stefan Stortecky, MD
Role: PRINCIPAL_INVESTIGATOR
Bern University Hospital
Locations
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Loma Linda University Health
Loma Linda, California, United States
Providence St. Joseph Orange
Orange, California, United States
Huntington Hospital
Pasadena, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Radiology and Imaging Associates
Lakeland, Florida, United States
Baptist Health South Florida
Miami, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
University of South Florida Tampa General Hospital
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Ascension Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Ascension St. Vincent Hospital - Indianapolis
Indianapolis, Indiana, United States
Norton Healthcare
Louisville, Kentucky, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Ascension St. John Hospital
Detroit, Michigan, United States
CentraCare St. Cloud Hospital
Saint Cloud, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Virtua Lourdes
Camden, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Northwell Health
Bay Shore, New York, United States
Gates Vascular Institute
Buffalo, New York, United States
NewYork-Presbyterian Columbia University Irving Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina Health
Chapel Hill, North Carolina, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Summa Akron City Hospital
Akron, Ohio, United States
Mercy Health West
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
St. Luke's University Hospital
Bethlehem, Pennsylvania, United States
AHN Saint Vincent Hospital
Erie, Pennsylvania, United States
UPMC Harrisburg
Harrisburg, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
MUSC Health University Medical Center
Charleston, South Carolina, United States
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, United States
Lexington Medical Center
West Columbia, South Carolina, United States
HCA TriStar Centennial Medical Center
Nashville, Tennessee, United States
Ascension Saint Thomas Hospital
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
HCA Medical City Heart and Spine
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Memorial Hermann Medical Center
Houston, Texas, United States
Methodist Main Hospital
San Antonio, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Providence Sacred Heart Medical Center
Spokane, Washington, United States
Ascension St. Elizabeth Hospital
Appleton, Wisconsin, United States
Gundersen Health System
La Crosse, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Universtitaetsklinikum Dusseldorf
Düsseldorf, , Germany
Herzzentrum Leipzig
Leipzig, , Germany
Marien Hospital Wesel GmbH
Wesel, , Germany
Inselspital - Universitätsspital Bern
Bern, , Switzerland
Countries
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References
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Gonsalves CF, Gibson CM, Stortecky S, Alvarez RA, Beam DM, Horowitz JM, Silver MJ, Toma C, Rundback JH, Rosenberg SP, Markovitz CD, Tu T, Jaber WA. Randomized controlled trial of mechanical thrombectomy vs catheter-directed thrombolysis for acute hemodynamically stable pulmonary embolism: Rationale and design of the PEERLESS study. Am Heart J. 2023 Dec;266:128-137. doi: 10.1016/j.ahj.2023.09.002. Epub 2023 Sep 12.
Jaber WA, Gonsalves CF, Stortecky S, Horr S, Pappas O, Gandhi RT, Pereira K, Giri J, Khandhar SJ, Ammar KA, Lasorda DM, Stegman B, Busch L, Dexter DJ 2nd, Azene EM, Daga N, Elmasri F, Kunavarapu CR, Rea ME, Rossi JS, Campbell J, Lindquist J, Raskin A, Smith JC, Tamlyn TM, Hernandez GA, Rali P, Schmidt TR, Bruckel JT, Camacho JC, Li J, Selim S, Toma C, Basra SS, Bergmark BA, Khalsa B, Zlotnick DM, Castle J, O'Connor DJ, Gibson CM; PEERLESS Committees and Investigators*. Large-Bore Mechanical Thrombectomy Versus Catheter-Directed Thrombolysis in the Management of Intermediate-Risk Pulmonary Embolism: Primary Results of the PEERLESS Randomized Controlled Trial. Circulation. 2025 Feb 4;151(5):260-273. doi: 10.1161/CIRCULATIONAHA.124.072364. Epub 2024 Oct 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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21-002
Identifier Type: -
Identifier Source: org_study_id