FlowTriever All-Comer Registry for Patient Safety and Hemodynamics
NCT03761173 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1200
Last updated 2025-10-01
Summary
To evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice.
Up to 300 additional patients with anticoagulation treatment as the initial planned primary treatment strategy for intermediate risk PE will also be evaluated (US only).
Conditions
- PE - Pulmonary Embolism
- PE - Pulmonary Thromboembolism
Interventions
- DEVICE
-
FlowTriever System
Thrombectomy
- DRUG
-
Anticoagulation Agents
Anticoagulation medication
Sponsors & Collaborators
-
Inari Medical
lead INDUSTRY
Principal Investigators
-
Catalin Toma, MD · University of Pittsburgh
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-15
- Primary Completion
- 2024-09-04
- Completion
- 2024-09-04
Countries
- United States
- Austria
- Belgium
- France
- Germany
- Netherlands
- Spain
- Switzerland
- United Kingdom
Study Locations
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