FlowTriever All-Comer Registry for Patient Safety and Hemodynamics

Completed

• Conditions: PE - Pulmonary Embolism; PE - Pulmonary Thromboembolism
• Interventions: Device: FlowTriever System; Drug: Anticoagulation Agents

• Registration Number: NCT03761173
• Lead Sponsor: Inari Medical

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-12-03
• Study Start: 2018-12-15
• Primary Completion: 2024-09-04
• Study Completion: 2024-09-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1186

Inclusion Criteria

• Clinical signs and symptoms consistent with acute PE

• Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery

• Scheduled for PE treatment with the FlowTriever System per the Investigator's discretion*

  • US only: Patients enrolled in the Conservative Therapy Sub-study are not required to meet this inclusion criteria but must instead be scheduled for primary anticoagulation therapy as the primary treatment strategy.

Exclusion Criteria

• Unable to be anticoagulated with heparin or alternative

• Diagnosis with a minor PE with a less than 0.9 RV/LV ratio

• Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated*

• Imaging evidence or other evidence that suggests, in the Investigator's opinion, the subject is not appropriate for mechanical thrombectomy intervention*

• Life expectancy < 30 days, as determined by Investigator

• Current participation in another investigational drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study

  • US Only Patients enrolled in the Conservative Therapy Sub-study are not required to meet these exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FlowTriever	FlowTriever System	Mechanical thrombectomy for pulmonary embolism
Conservative Therapy Sub-Study	Anticoagulation Agents	Anticoagulation medication for pulmonary embolism (as directed by treating physician)

Primary Outcome Measures

Name	Time	Method
Composite Major Adverse Events	48-hours	Rate of subjects with composite of device-related death, major bleeding, device or procedure-related adverse events

Secondary Outcome Measures

Name	Time	Method
Individual Major Adverse Events	48-hours	Rate of subjects with individual components of composite MAE
Device-related serious adverse events	30-days	Rate of device-related SAEs
All-cause mortality	30-days	Rate of deaths

Trial Locations

Locations (81)

UAB Division of Cardiovascular Disease; 🇺🇸 Birmingham, Alabama, United States

University of Arizona College of Medicine; 🇺🇸 Tucson, Arizona, United States

Pima Heart and Vascular; 🇺🇸 Tucson, Arizona, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

Memorial Hospital Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Lakeland Vascular Institute; 🇺🇸 Lakeland, Florida, United States

Palmetto General Hospital; 🇺🇸 Miami, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

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