Comparing FlowTriever System to Standard Care for High-Risk Pulmonary Embolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of the FlowTriever System compared to standard care in treating patients with high-risk pulmonary embolism (PE). It involves a randomized controlled trial design, focusing on patients who have objective evidence of a proximal filling defect in their pulmonary arteries and exhibit right ventricular dysfunction. The study aims to determine if the FlowTriever System can improve outcomes for these patients compared to traditional treatment methods.

Why it matters

Who can join: the full rules

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 it's running

• Yale University
  New Haven, Connecticut, United States Recruiting
• AdventHealth Orlando
  Orlando, Florida, United States Recruiting
• Orlando Health Regional Medical Center
  Orlando, Florida, United States Recruiting
• Sarasota Memorial Hospital
  Sarasota, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• University of Mississippi Medical Center
  Jackson, Mississippi, United States Recruiting

Study contacts

• Principal investigator: Nicolas Meneveau, MD PhD — Centre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, France
• Study coordinator: Tine Devolder
• Email: tine.devolder@stryker.com
• Phone: +32 476 53 88 05

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.