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New treatment option for Pulmonary Embolism
Official title The PERSEVERE Study
ClinicalTrials.gov ID: NCT06588634
What this study is testing
- What it's testing
- Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age at enrollment ≥18 years
- Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
- High-risk class of acute PE
- RV dysfunction, as defined RV/LV ratio ≥1.0
- Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent...
You likely can't join if
- Prolonged cardiac 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 for catheter-based intervention
- 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)
- Life-threatening active bleeding or hemorrhage into a critical area
See the full eligibility criteria
- Age at enrollment ≥18 years
- Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
- High-risk class of acute PE
- RV dysfunction, as defined RV/LV ratio ≥1.0
- 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...
- Prolonged cardiac 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 for catheter-based intervention
- 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)
- Life-threatening active bleeding or hemorrhage into a critical area
- Known intracranial tumor
- End-stage medical condition with life expectancy \<3 months (irrespective of the severity of acute PE), as determined by the Investigator
- Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
- Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT)
- Current participation in another drug or device study that may interfere with the conduct of this trial
- Ventricular arrhythmias refractory to treatment at the time of enrollment
- 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...
- Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
- Subject was previously enrolled in this study
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Orlando, Florida, United States
- Sarasota, Florida, United States
- Atlanta, Georgia, United States
- Jackson, Mississippi, United States
- Bay Shore, New York, United States
- Buffalo, New York, United States
- Akron, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
- Besançon, France
- Montpellier, France
- Nîmes, France
- Paris, France
- Chemnitz, Germany
- Dresden, Germany
- Mainz, Germany
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Orlando, Florida, United States; Sarasota, Florida, United States; Atlanta, Georgia, United States; Jackson, Mississippi, United States; Bay Shore, New York, United States and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.