NCT03761173

FlowTriever All-Comer Registry for Patient Safety and Hemodynamics

FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (actual)
• Sponsor: Inari Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	FlowTriever System	Thrombectomy
DRUG	Anticoagulation Agents	Anticoagulation medication

Timeline

• Start date: 2018-12-15
• Primary completion: 2024-09-04
• Completion: 2024-09-04
• First posted: 2018-12-03
• Last updated: 2025-10-01
• Results posted: 2025-10-01

Locations

81 sites across 9 countries: United States, Austria, Belgium, France, Germany, Netherlands, Spain, Switzerland, United Kingdom