NCT05560763

FlowTriever2 Pulmonary Embolectomy Clinical Study

FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Inari Medical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter for mechanical thrombectomy of pulmonary embolism (PE).

Detailed description

The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the FlowTriever2 Catheter for mechanical thrombectomy in patients eligible for endovascular treatment of acute pulmonary embolism (PE). The subjects who meet the inclusion/exclusion criteria will be enrolled in the study. The enrollment period is over a period of approximately 12 months. All study subjects actively participate through the 30-day visit (-5 / +15 days) following treatment. Study participation includes screening, baseline, treatment, 48-hour visit, and 30-day follow-up. The study population consists of subjects that have an acute PE. Subject eligibility is determined based on data available to the Investigator at the time of enrollment. Subjects must meet all inclusion and no exclusion criteria to be eligible for the study. All subjects that complete the procedure and the follow-ups are included in the analysis.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
DEVICE	FlowTriever2 Catheter	The FlowTriever2 Catheter is utilized for the treatment of Pulmonary Embolism via mechanical thrombectomy of thrombus in the pulmonary arteries.

Timeline

• Start date: 2023-02-14
• Primary completion: 2024-09-09
• Completion: 2024-09-09
• First posted: 2022-09-29
• Last updated: 2025-10-08
• Results posted: 2025-09-23

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study