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

Inari Medical

Status: Completed

Conditions: PE - Pulmonary Thromboembolism; PE - Pulmonary Embolism

Treatments: Device: FlowTriever System; Drug: Anticoagulation Agents

Study type: Observational

Funder types: Industry

Identifiers

NCT03761173

18-002

Details and patient eligibility

About

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).

Enrollment: 1,186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,186 participants in 2 patient groups

FlowTriever

Description:

Mechanical thrombectomy for pulmonary embolism

Treatment:

Device: FlowTriever System

Conservative Therapy Sub-Study

Description:

Anticoagulation medication for pulmonary embolism (as directed by treating physician)

Treatment:

Drug: Anticoagulation Agents