The PEERLESS II Study
NCT06055920 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200
Last updated 2026-05-06
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.
Conditions
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.
Sponsors & Collaborators
-
Inari Medical
lead INDUSTRY
Principal Investigators
-
Frances Mae West, MD · Jefferson Health
-
Jay Giri, MD · Penn Medicine
-
Bernhard Gebauer, MD · Charité University Hospital Berlin
-
Felix Mahfoud, MD · Universitaetsspital Basel
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-17
- Primary Completion
- 2026-07-31
- Completion
- 2026-07-31
- FDA Device
- Yes
Countries
- United States
- Belgium
- Canada
- Denmark
- France
- Germany
- Poland
- Spain
- Switzerland
Study Locations
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