Clinical trial NCT06187987: Mechanical Thrombectomy With the FlowTriever Device in Acute Pulmonary Embolism - a Retrospective Analysis
Official title: Outcomes of Mechanical Thrombectomy With the FlowTriever Device in Acute Pulmonary Embolism, Results of a Swedish Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Keywords: FlowTriever
Catheter-Directed Intervention
Aspirational thrombectomy
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Stockholm South General Hospital
name: Karolinska University Hospital
name: Danderyd Hospital
name: University Hospital, Linkoeping
name: Sunderby Hospital
First posted: 2024-01-03
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with acute PE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite endpoint of survival and major bleeding
timeFrame: up to 7 days and up to 30 days
Secondary outcomes:
measure: Survival
timeFrame: up to 30 days
measure: Major Bleeding
timeFrame: up to 7 days
measure: Right Ventricle/Left Ventricle (RV/LV) ratio
timeFrame: from 48 hours before intervention up to 48 hours after intervention
measure: Total Length of stay in the ICU or IMCU
timeFrame: From administration until discharge from ICU/IMCU, up to 30 days
measure: Total Length of stay in hospital
timeFrame: From diagnosis of PE until discharge from hospital, up to 30 days
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Kristina Svennerholm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: