Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care (PERSEVERE)
Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care (PERSEVERE)
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Clinical Trial Information
Trial Contact: Ngo, George M.; Harms, Gabrielle T; Velez, Vanessa; Rodriguez, Adriana C
Trial Phone: 3218439657 ; 321.841.3686 ; 321.843.5390 ; 321.843.1838
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IRB No: W25.193.07
Protocol Abbrev: PERSEVERE
Principal Investigator: Joel J Santora, MD
Phase: Device: Significant Risk
Age Group: Adult
Secondary Protocol No: 24-002
Treatment: Flow Triever System plus anticoagulation
Therapies Involved: Procedural
ClinicalTrials.gov ID: NCT06588634
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Objective
The primary study objective is to compare the in-hospital clinical outcomes of patients with high-risk acute pulmonary embolism (PE) treated with the FlowTriever System plus anticoagulation versus Standard of Care Therapy.
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Key Eligibility
Subjects must meet each of the following criteria to be included in the study:
1. Age at enrollment ≥18 years
2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery, as confirmed by CTPA, pulmonary angiography, or other imaging modality, with symptom onset ≤2 weeks before randomization
3. High-risk class of acute PE, including one or more of the following:
a) Sustained (>15 min) low blood pressure (i.e., arterial hypotension with SBP <90 mm Hg or vasopressor support to maintain SBP >90 mm Hg), after appropriate fluid resuscitation and not caused by new onset arrhythmia, hypovolemia, or sepsis1 or
b) Elevated venous lactate ≥4 mmol/L despite adequate intravascular volume status, and clinical signs suggesting obstructive shock/hypoperfusion or
c) Need for ECMO life support before randomization (e.g., for acute refractory cardiovascular failure, rapidly deteriorating cardiogenic shock, or a short cardiopulmonary resuscitation) or
d) Resuscitated cardiac arrest with Glasgow Coma Scale2 ≥13 without need for mechanical ventilation or, for patients who are intubated at the time of the assessment, Glasgow Coma Scale ≥8T; the arrest suspected to be related to the PE
4. RV dysfunction, as defined RV/LV ratio ≥1.0
5. Willing and able to provide informed consent, or if unable, through a legally 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.
