The PEERLESS Study
- Conditions
- Pulmonary Thrombo-embolismPulmonary Embolism
- 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
- 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 Device and drug-related serious adverse events 30 days from index procedure 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 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
Scroll for more (50 remaining)Brigham and Women's Hospital🇺🇸Boston, Massachusetts, United States