PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism
NCT: NCT06055920 ·
Status: RECRUITING ·
Phase: N/A
· Sponsor: Inari Medical
· Started: 2023-11-17
· Est. Completion: 2026-07
Official Summary
This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute PE.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 1,200 participants
Interventions
- DEVICE: FlowTriever System — Mechanical Thrombectomy for pulmonary embolism
- DRUG: 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.
Primary Outcomes
- Composite clinical endpoint constructed as a win ratio, a hierarchy of the following, which are assessed post-randomization: (through discharge or 30 days, whichever is sooner / dyspnea at 48 hours)
Secondary Outcomes
- Composite clinical endpoint constructed as a win ratio hierarchy of the following three components, assessed post randomization: (up to 30 days)
- All-cause and PE-related mortality (At 30 and 90 days)
- All-cause and PE-related readmissions (At 30 and 90 days)
- Clinical deterioration (Through discharge or up to 30 days after randomization, whichever is sooner)
- Bailout therapy (Through discharge or up to 30 days after randomization, whichever is sooner)
Trial Locations
- 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
- ...and 10 more locations
More Pulmonary Embolism Trials
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.