FlowTriever System for Pulmonary Embolism
Recruiting in Palo Alto (17 mi)
+6 other locations
Overseen byStavros Konstantinides, MD PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Inari Medical
Must not be taking: Thrombolytics, Anticoagulants
Disqualifiers: Neurological deficit, Stroke, Bleeding, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?RCT of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are unable to take blood thinners or have a condition called heparin-induced thrombocytopenia, you may not be eligible to participate.
What data supports the effectiveness of the FlowTriever treatment for pulmonary embolism?
The FlowTriever treatment for pulmonary embolism has shown a 90% success rate in reducing pulmonary artery pressures and improving heart function in patients with massive and submassive pulmonary embolism, according to studies. It is effective in treating intermediate-risk and high-risk pulmonary embolism without the need for clot-dissolving drugs, which can have bleeding risks.
12345Is the FlowTriever System safe for treating pulmonary embolism?
The FlowTriever System has been shown to be safe for treating pulmonary embolism, as it allows for the removal of blood clots without the use of clot-dissolving drugs, which can have bleeding risks. Clinical studies and real-world experiences have demonstrated its safety in treating both intermediate-risk and high-risk pulmonary embolism.
13467How is the FlowTriever treatment different from other treatments for pulmonary embolism?
The FlowTriever System is unique because it mechanically removes blood clots from the lungs without using thrombolytic drugs, which can have a high risk of causing bleeding. This makes it a safer option for some patients compared to traditional treatments that rely on medication to dissolve clots.
12568Eligibility Criteria
The PERSEVERE study is for adults over 18 with a high-risk class of acute pulmonary embolism (PE), which means they have a blockage in the lung's main artery. They must also show right ventricle dysfunction due to this condition and be able to start treatment within 4 hours of diagnosis.Inclusion Criteria
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
Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
I am 18 years old or older.
+3 more
Exclusion Criteria
I have a history of chronic blood clots in my lungs.
Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
End-stage medical condition with life expectancy <3 months (irrespective of the severity of acute PE), as determined by the Investigator
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either the FlowTriever System or Standard of Care for high-risk pulmonary embolism
Up to 7 days
In-hospital treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
This randomized controlled trial compares two treatments for severe PE: the standard care typically given for such cases versus an intervention using the FlowTriever System, which is designed to remove blood clots from the arteries in the lungs.
2Treatment groups
Active Control
Group I: Standard of CareActive Control1 Intervention
Group II: FlowTrieverActive Control1 Intervention
FlowTriever System is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as FlowTriever for:
- Pulmonary embolism
- Removal of emboli and thrombi from blood vessels
🇪🇺 Approved in European Union as FlowTriever for:
- Pulmonary embolism
- Removal of emboli and thrombi from blood vessels
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sarasota Memorial HospitalSarasota, FL
SUNY, The University at BuffaloBuffalo, NY
Allegheny General HospitalPittsburgh, PA
HCA Tristar/CentennialNashville, TN
More Trial Locations
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Who Is Running the Clinical Trial?
Inari MedicalLead Sponsor
References
FlowTriever System for Pulmonary Embolism: A Review of Clinical Evidence. [2023]Pulmonary embolism (PE) is a significant cause of cardiovascular mortality, and its incidence has been increasing due to the growing aging population. Systemic or catheter-directed thrombolytic treatment for PE has an increased risk of bleeding that may offset the benefit in some patients. Mechanical thrombectomy devices such as the FlowTriever System are designed to resolve vascular occlusion and correct ventilation-perfusion mismatch without the need for thrombolytic drugs. This review covers the FlowTriever system, clinical data from the FlowTriever Pulmonary Embolectomy Clinical Study, FlowTriever for Acute Massive Pulmonary Embolism, and FlowTriever All-comer Registry for Patient Safety and Hemodynamics trials, and real-world experiences, demonstrating its safety and effectiveness in treating intermediate-risk and high-risk PE. Additionally, we explore off-label uses of the FlowTriever System for various large vessel thromboses.
The expanding role of percutaneous mechanical thrombus debulking and extraction in the treatment of critical pulmonary embolism. [2021]Massive and sub-massive pulmonary embolism require expeditious management of the cumulative deleterious effects caused by rapidly deteriorating hemodynamic condition, severely compromised cardiac performance, and associated respiratory failure that carry a predictable catastrophic outcome. The FlowTriever thrombectomy system as applied in 34 patients for massive and submassive pulmonary embolism resulted in 90% success rate including adequate reduction of the PA pressures, improved RV performance, increased CI, improved BP, and heart rates and decreased the need for vasopressors support within 24 hr. The role of percutaneous mechanical thrombus debulking and extraction continue to expand, and the yield of the FlowTriever thrombectomy system should be considered when determining which intervention is best suited to patients with massive and submassive pulmonary embolism.
Safety and Efficacy of Acute Pulmonary Embolism Treated via Large-Bore Aspiration Mechanical Thrombectomy Using the Inari FlowTriever Device. [2020]To report initial experience with safety and efficacy in the treatment of pulmonary embolism (PE) using the FlowTriever device.
Clot Extraction With the FlowTriever Device in Acute Massive Pulmonary Embolism. [2019]Clinical guidelines support the use of systemic thrombolytic therapy for acute massive pulmonary embolism (PE). When anticoagulation and thrombolysis fail or are contraindicated, options become limited. We report an acute PE case in which treatment options were limited, and a novel device, the FlowTriever (Inari Medical, Irvine, California), was successfully used. This is the first case report of the use of this device that we are aware of.
Inari large-bore mechanical thrombectomy in intermediate-high risk submassive PE patients: Case series and literature review. [2022]Pulmonary embolism (PE) is one of the most common causes of cardiovascular (CV) mortality worldwide. Owing to the associated morbidity and mortality with other treatment modalities, including systemic thrombolysis, a discernible change in the era of acute pulmonary embolism management has been reported. Catheter-directed thrombectomy using the FlowTriever system (Inari Medical; Irvine, CA, USA) was shown to reduce endpoints of interest in patients with acute intermediate-high risk PE and was associated with rapid hemodynamic improvement. In this report, we describe our experience with three cases of patients presenting with submassive PE, whereby immediate pulmonary artery pressure improvement was evident in all cases after successful mechanical thrombectomy. Our experience supports the use of FlowTriever mechanical thrombectomy for the treatment of submassive PE in clinical practice, with a call for further research to establish associated benefits.
A report of 2 cases of the use of the Inari FlowTriever System in the treatment of pulmonary embolism. [2022]The FlowTriever System (Inari Medical, Irvine, California) is the first FDA-approved mechanical thrombectomy device used for treatment of pulmonary embolism. This device enables nonsurgical removal of pulmonary blood clots without the use of thrombolytic medication and its associated risks. We report 2 cases of successful application of the Inari FlowTriever in treatment of pulmonary embolism and right atrial thrombus.
Outcomes of Catheter-Based Pulmonary Artery Embolectomy in Patients With Sub-Massive to Massive Pulmonary Embolism. [2023]Background Pulmonary embolism (PE) is the third leading cause of cardiovascular death after myocardial infarction and stroke. The ideal therapeutic approach for these patients remains undetermined. We report our single-center outcome data for using a catheter-based pulmonary artery thrombectomy using the FlowTriever (Inari Medical, Irvine, CA) device as management for patients with submassive PE. Methods We retrospectively collected data from a single center of patients who underwent thrombectomy using INARI FlowTriever device. The data on baseline characteristics, procedural and clinical outcomes was collected and analysed Results A total of 38 patients with PE treated endovascularly with the FlowTriever device were identified: 33 with submassive PE and five with massive PE. The mean age was 65.9 years (95% CI 61.9 - 69.8), and most patients were male (73.7%). All patients had right heart strain as the main indication for thrombectomy. Four patients (10.53%) required pressor support before the procedure. In 31 patients, pre- and post-thrombectomy average mean pulmonary artery pressure (mPAP) was improved significantly by 22% (p
Percutaneous Thrombectomy in Emergency Department Patients with Pulmonary Embolism: The FLARE ED Sub-study. [2021]The FlowTriever Pulmonary Embolectomy Clinical Study (FLARE) was a multicenter, single-arm trial that demonstrated effectiveness of the FlowTriever percutaneous pulmonary embolectomy system in reducing right ventricular/left ventricular (RV/LV) diameter ratio in patients with acute intermediate-risk pulmonary embolism (PE). Patients diagnosed in emergency departments (EDs) with acute PE may have a different presentation from those diagnosed in an in-hospital setting.