Mechanical Thrombectomy With the FlowTriever Device in Acute Pulmonary Embolism - a Retrospective Analysis

Last updated: May 16, 2025
Sponsor: Kristina Svennerholm
Overall Status: Completed

Phase

N/A

Condition

Claudication

Lung Injury

Vascular Diseases

Treatment

Mechanical thrombectomy

Intravenous thrombolysis

Clinical Study ID

NCT06187987
Flow-PE
  • Ages > 18
  • All Genders

Study Summary

International guidelines recommend intravenous thrombolysis (IVT) for high-risk pulmonary embolism (PE). In high-risk PE where IVT is contraindicated or has failed, surgical embolectomy or catheter-directed intervention (CDI) is recommended. CDI is also recommended as an alternative in patients with intermediate-risk PE with haemodynamic deterioration during anticoagulation treatment.

Although there is a lack of randomized studies comparing CDI to anticoagulation or systemic thrombolysis in PE, several studies and recent meta-analyses have shown that CDI is an effective treatment that is associated with fewer complications than IVT, especially bleeding.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years

  • Acute PE verified by computed tomography (CT) or angiography

  • PE treated with thrombolysis or FlowTriever® during the time period from January 1stof the year when FlowTriever was introduced at each respective participating centerto the end of 2023.

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 132
Treatment Group(s): 2
Primary Treatment: Mechanical thrombectomy
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
March 31, 2025

Study Description

The FlowTriever® retrieval/aspiration system is the first mechanical thrombectomy device to receive PE as an indication from the United States Food and Drug administration agency. It combines large-bore aspiration with expanding mesh disks designed to trap and subsequently retract the blood clots from the pulmonary arteries. While Inari Medical, the medical device company that produces the FlowTriever® system, has initiated and published a few prospective trials on FlowTriever® in PE, non-industry sponsored studies are small and mostly retrospective.

In 2021 FlowTriever® became the primary device for CDI in PE at Sahlgrenska University Hospital in Gothenburg, Sweden. Concurrently, several hospitals in Sweden have started using FlowTriever® in high-risk PE. As such, the method needs evaluation and validation on a local and national level.

This retrospective observational study aims to evaluate the outcomes of patients with acute PE treated with the FlowTriever® device in Sweden. A control group consisting of PE patients treated with IVT will be used for comparison.

Connect with a study center

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.