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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06187987
• Other study ID #: Flow-PE
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Freyr Einarsson, MD
• Phone: +46500431036
• Email: freyr.einarsson[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 31, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• Mechanical thrombectomy
Aspirational mechanical thrombectomy

Drug:
• Intravenous thrombolysis
Intravenous thrombolysis with tissue-type plasminogen activator (tPA)

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (6)

Lead Sponsor	Collaborator
Kristina Svennerholm	Danderyd Hospital, Karolinska University Hospital, Stockholm South General Hospital, Sunderby Hospital, University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of survival and major bleeding	Composite endpoint of survival at 30 days and major bleeding within 7 days, after intervention.	up to 7 days and up to 30 days
Secondary	Survival	Survival at 30 days.	up to 30 days
Secondary	Major Bleeding	Major bleeding within 7 days after intervention.	up to 7 days
Secondary	Right Ventricle/Left Ventricle (RV/LV) ratio	Change in RV/LV-ratio with the intervention.	from 48 hours before intervention up to 48 hours after intervention
Secondary	Total Length of stay in the ICU or IMCU	Length of stay in the ICU/IMCU	From administration until discharge from ICU/IMCU, up to 30 days
Secondary	Total Length of stay in hospital	Length of stay in hospital	From diagnosis of PE until discharge from hospital, up to 30 days