At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- FlowTriever System (device), Standard of Care (procedure)
- How long the study runs
- Study runs about 38 months (dates as stated)
- About the drug or intervention
- FlowTriever System — device: Mechanical thrombectomy for pulmonary embolism · Standard of Care — procedure: Standard of care treatment for pulmonary embolism
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 200
- Started
- 2024-12-16
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for pulmonary embolism
- • NA - 200 participants
- • Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with pulmonary embolism
Where?
- • London - Royal Free Hospital London
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care
Pulmonary EmbolismPulmonary Thromboembolism
How this trial compares with your answers
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What we know so far
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Age at enrollment ≥18 years
- ✓Objective evidence of a proximal filling defect in at least one main or lobar lung artery
- ✓High-risk class of acute PE
- ✓RV dysfunction, as defined RV/LV ratio ≥1.0
Who cannot take part
- ✗Prolonged heart arrest with loss of consciousness associated with neurological deficit.
- ✗Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate...
- ✗Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH
- ✗Recent stroke (\<14 days)
- ✗Recent cranial or spinal surgery (\<14 days)
See the full criteria
Inclusion Criteria:
1. Age at enrollment ≥18 years
2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
3. High-risk class of acute PE
4. RV dysfunction, as defined RV/LV ratio ≥1.0
5. Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards
Exclusion Criteria:
1. Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.
2. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention
3. Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH
4. Recent stroke (\<14 days)
5. Recent cranial or spinal surgery (\<14 days)
6. Life-threatening active bleeding or hemorrhage into a critical area
7. Known intracranial tumor
8. End-stage medical condition with life expectancy \<3 months (irrespective of the severity of acute PE), as determined by the Investigator
9. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
10. Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT)
11. Current participation in another drug or device study that may interfere with the conduct of this trial
12. Ventricular arrhythmias refractory to treatment at the time of enrollment
13. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments), including a contraindication to use of FlowTriever System per local approved labeling
14. Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
15. Subject was previously enrolled in this study
16. Subject has received prior thrombolytic (systemic or catheter-directed) therapy for any reason or thrombectomy (surgical or catheter-based) therapy for index PE, within 30 days prior to randomization
Where Is This Study? (1 UK site)
Royal Free Hospital London
London, United Kingdom
How to Get in Touch
Tine Devolder
Sponsor contactCONTACT
+32 476 53 88 05 tine.devolder@stryker.com
Jen Foss
Sponsor contactCONTACT
978-587-6598 jenifer.foss@stryker.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10
