Pulmonary EmbolismNCT06187987
Mechanical Thrombectomy With the FlowTriever Device in Acute Pulmonary Embolism - a Retrospective Analysis
An observational study of Pulmonary Embolism, run by Kristina Svennerholm at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Mechanical thrombectomy and Intravenous thrombolysis
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 132 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with acute PE
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Mechanical Thrombectomy With the FlowTriever Device in Acute Pulmonary Embolism, Results of a Swedish 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.
Read the 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.
- Conditions
- Pulmonary Embolism
- Being tested
- Mechanical thrombectomy, Intravenous thrombolysis
- Keywords
- FlowTriever, Catheter-Directed Intervention, Aspirational thrombectomy
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical thrombectomyDevice
Also called FlowTriever
Aspirational mechanical thrombectomy
Intravenous thrombolysisDrug
Also called Alteplase
Intravenous thrombolysis with tissue-type plasminogen activator (tPA)
| Study group | Role | What they receive |
|---|---|---|
| FlowTriever | Acute PE patients treated with the FlowTriever device Receives: Device: Mechanical thrombectomy | |
| Intravenous Thrombolysis | Acute PE patients treated with intravenous thrombolysis Receives: Drug: Intravenous thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of survival and major bleeding
Composite endpoint of survival at 30 days and major bleeding within 7 days, after intervention.
Measured: up to 7 days and up to 30 days
Secondary outcomes (5)
Survival
Survival at 30 days.
Measured: up to 30 days
Major Bleeding
Major bleeding within 7 days after intervention.
Measured: up to 7 days
Right Ventricle/Left Ventricle (RV/LV) ratio
Change in RV/LV-ratio with the intervention.
Measured: from 48 hours before intervention up to 48 hours after intervention
Total Length of stay in the ICU or IMCU
Length of stay in the ICU/IMCU
Measured: From administration until discharge from ICU/IMCU, up to 30 days
Total Length of stay in hospital
Length of stay in hospital
Measured: From diagnosis of PE until discharge from hospital, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Apr 2023
- Primary completion31 Jan 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristina Svennerholm
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital, Karolinska University Hospital, Danderyd Hospital, University Hospital, Linkoeping, Sunderby Hospital
- Responsible party
- Sponsor-investigator, Kristina Svennerholm, Sahlgrenska University Hospital
- Investigators
- Kristina Svennerholm, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187987
- Sponsor's protocol ID
- Flow-PE
- Status last verified
- May 2025
- First submitted
- 12 Dec 2023
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Mechanical Thrombectomy With the FlowTriever Device in Acute Pulmonary Embolism, Results of a Swedish Retrospective Analysis
- ClinicalTrials.gov ID
- NCT06187987
- Acronym / sponsor ID
- Flow-PE
- Conditions
- Pulmonary Embolism
- Keywords
- FlowTriever, Catheter-Directed Intervention, Aspirational thrombectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Kristina SvennerholmUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital, Karolinska University Hospital, Danderyd Hospital, University Hospital, Linkoeping, Sunderby Hospital
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FlowTriever | – | Device: Mechanical thrombectomyAcute PE patients treated with the FlowTriever device |
| Intravenous Thrombolysis | – | Drug: Intravenous thrombolysisAcute PE patients treated with intravenous thrombolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with acute PE
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical thrombectomyAlso: FlowTrieverAspirational mechanical thrombectomy | Device | FlowTriever |
| Intravenous thrombolysisAlso: AlteplaseIntravenous thrombolysis with tissue-type plasminogen activator (tPA) | Drug | Intravenous Thrombolysis |
Primary outcome
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.
5 secondary outcomes
Survival
Time frame: up to 30 days
Major Bleeding
Time frame: up to 7 days
Right Ventricle/Left Ventricle (RV/LV) ratio
Time frame: from 48 hours before intervention up to 48 hours after intervention
Total Length of stay in the ICU or IMCU
Time frame: From administration until discharge from ICU/IMCU, up to 30 days
Total Length of stay in hospital
Time frame: From diagnosis of PE until discharge from hospital, up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Svennerholm, MD, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Kristina Svennerholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of survival and major bleeding (time frame: up to 7 days and up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.