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

NCT06187987 | Completed FDA Drug FDA Device

• 1 other identifier: Flow-PE
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism

Keywords

FlowTriever; Catheter-Directed Intervention; Aspirational thrombectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Survival

  up to 30 days

• Major Bleeding

  up to 7 days

• Right Ventricle/Left Ventricle (RV/LV) ratio

  from 48 hours before intervention up to 48 hours after intervention

• Total Length of stay in the ICU or IMCU

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

• Total Length of stay in hospital

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

Study Arms (2)

FlowTriever

Acute PE patients treated with the FlowTriever device

Device: Mechanical thrombectomy

Intravenous Thrombolysis

Acute PE patients treated with intravenous thrombolysis

Drug: Intravenous thrombolysis

Interventions

Mechanical thrombectomy DEVICE

Aspirational mechanical thrombectomy

Also known as: FlowTriever

FlowTriever

Intravenous thrombolysis DRUG

Intravenous thrombolysis with tissue-type plasminogen activator (tPA)

Also known as: Alteplase

Intravenous Thrombolysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with acute PE

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Kristina Svennerholm: lead
• Stockholm South General Hospital: collaborator
• Karolinska University Hospital: collaborator
• Danderyd Hospital: collaborator
• University Hospital, Linkoeping: collaborator
• Sunderby Hospital: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Kristina Svennerholm, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator. MD. PhD.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 3, 2024
• Study Start: April 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

SE (1)