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Completed

NCT Number: NCT06187987

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

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital

Gothenburg, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 1st of the year when FlowTriever was introduced at each respective participating center to the end of 2023.

Exclusion criteria

  • None

Treatment and study plan

Mechanical Thrombectomy

Device

Aspirational mechanical thrombectomy

Other names: FlowTriever

Intravenous thrombolysis

Drug

Intravenous thrombolysis with tissue-type plasminogen activator (tPA)

Other names: Alteplase

Primary outcomes

  1. Composite endpoint of survival and major bleeding

    Time frame: up to 7 days and up to 30 days

    Composite endpoint of survival at 30 days and major bleeding within 7 days, after intervention.

Secondary outcomes

  1. Survival

    Time frame: up to 30 days

    Survival at 30 days.

  2. Major Bleeding

    Time frame: up to 7 days

    Major bleeding within 7 days after intervention.

  3. Right Ventricle/Left Ventricle (RV/LV) ratio

    Time frame: from 48 hours before intervention up to 48 hours after intervention

    Change in RV/LV-ratio with the intervention.

  4. Total Length of stay in the ICU or IMCU

    Time frame: From administration until discharge from ICU/IMCU, up to 30 days

    Length of stay in the ICU/IMCU

  5. Total Length of stay in hospital

    Time frame: From diagnosis of PE until discharge from hospital, up to 30 days

    Length of stay in hospital

Sponsors and collaborators

Lead sponsor

Kristina Svennerholm

Other

Collaborators

  • Danderyd Hospital
  • Karolinska University Hospital
  • Stockholm South General Hospital
  • Sunderby Hospital
  • University Hospital, Linkoeping

Registry information

Official study title

Outcomes of Mechanical Thrombectomy With the FlowTriever Device in Acute Pulmonary Embolism, Results of a Swedish Retrospective Analysis

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2024
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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