The PEERLESS Study
- Conditions
- Pulmonary Thrombo-embolismPulmonary Embolism
- Interventions
- Device: FlowTriever SystemDevice: Catheter-Directed Thrombolysis
- Registration Number
- NCT05111613
- Lead Sponsor
- Inari Medical
- Brief Summary
A prospective, multicenter, randomized controlled trial of the FlowTriever System compared to Catheter-Directed Thrombolysis (CDT) for use in the treatment of acute pulmonary embolism. The trial includes a non-randomized cohort of subjects with an absolute contraindication to thrombolysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 692
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Randomized Controlled Trial Cohort - FlowTriever Arm FlowTriever System Mechanical thrombectomy for pulmonary embolism using the FlowTriever System. Non-Randomized Absolute Contraindication to Thrombolytics Cohort FlowTriever System Mechanical thrombectomy for pulmonary embolism using the FlowTriever System. Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm Catheter-Directed Thrombolysis Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
- Primary Outcome Measures
Name Time Method Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: Hospital discharge or at 7 days after the index procedure, whichever is sooner 1. All-cause mortality, or
2. Intracranial hemorrhage (ICH), or
3. Major bleeding per ISTH definition, or
4. Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy, or
5. ICU admission and ICU length-of-stay during the index hospitalization and following the index procedure.
- Secondary Outcome Measures
Name Time Method Intracranial hemorrhage (ICH) Hospital discharge or at 7 days after the index procedure, whichever is sooner All-cause mortality Hospital discharge or at 7 days after the index procedure, whichever is sooner Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy Hospital discharge or at 7 days after the index procedure, whichever is sooner Device and drug-related serious adverse events 30 days from index procedure Pulmonary Embolism Quality of Life (PEmb-QOL) At 30 day visit Composite clinical endpoint constructed as a win ratio hierarchy of the following four components: Hospital discharge or at 7 days after the index procedure, whichever is sooner * All-cause mortality, or
* Intracranial hemorrhage (ICH), or
* Major bleeding per ISTH definition, or
* Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapyMajor bleeding per ISTH definition Hospital discharge or at 7 days after the index procedure, whichever is sooner Clinically Relevant Non-Major (CRNM) and Minor bleeding events Hospital discharge or at 7 days after the index procedure, whichever is sooner Change in right-ventricular/left-ventricular (RV/LV) ratio, as measured by echocardiography or CT Baseline to 24 hour visit EQ-5D-5L Quality of Life At 30 day visit ICU admission and ICU length of stay during the index hospitalization and following the index procedure Hospital discharge or at 7 days after the index procedure, whichever is sooner All cause mortality 30 days from index procedure Modified Medical Research Council (mMRC) dyspnea score At 24 hour and 30 day visits The range of scores is zero to four (worse)
Length of total hospital stay and post-index-procedure hospital stay To a maximum of 30 days PE-related and all-cause readmission 30 days from index procedure
Trial Locations
- Locations (60)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
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 Heralthcare
🇺🇸Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Ascension St. John Hospital
🇺🇸Detroit, Michigan, United States
CentraCare St. Cloud Hospital
🇺🇸St. 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
🇺🇸Saint 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