FlowTriever System + Anticoagulation for Pulmonary Embolism
Recruiting in Palo Alto (17 mi)
+89 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Inari Medical
Must be taking: Anticoagulants
Disqualifiers: Hemodynamic instability, CTEPH, Pregnancy, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute PE.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, you must be able to take certain blood thinners like heparin or enoxaparin to participate.
What data supports the effectiveness of the FlowTriever System + Anticoagulation treatment for Pulmonary Embolism?
Research shows that the FlowTriever System is effective in treating pulmonary embolism by safely removing blood clots without the need for clot-dissolving drugs, which can have bleeding risks. Studies and real-world experiences demonstrate its success in improving blood flow and reducing pressure in the lungs for patients with high-risk pulmonary embolism.
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 and effectiveness in treating different risk levels of pulmonary embolism.
12356How is the FlowTriever System + Anticoagulation treatment different from other treatments for pulmonary embolism?
The FlowTriever System is unique because it mechanically removes blood clots from the lungs without the need for thrombolytic drugs, which can have bleeding risks. This makes it a safer option for patients who cannot use traditional clot-busting medications.
12345Eligibility Criteria
The PEERLESS II Study is for adults over 18 with a recent pulmonary embolism (PE) diagnosis, specific heart dysfunction due to PE, and additional risk factors like low blood pressure or elevated heart rate. People can't join if they've had certain advanced treatments for PE in the last month, have severe conditions limiting life expectancy, are pregnant, or have contraindications to the FlowTriever System or anticoagulants.Inclusion Criteria
I have at least two risk factors from different categories related to heart, blood markers, or breathing.
You have a condition where the right side of your heart is not working properly, as shown by specific tests.
My symptoms started within 14 days after my PE was confirmed.
+3 more
Exclusion Criteria
I received advanced treatment for a blood clot in my lung within the last 30 days.
I had a severe blood clot in my lung and was very unstable but am stable now.
I have or had chronic lung blood clot issues as per 2019 guidelines.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either the FlowTriever System plus anticoagulation or anticoagulation alone for intermediate-risk acute PE
4 weeks
Weekly visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 months
Visits at 48 hours, 1 month, and 3 months
Extension
Participants may continue to be monitored for long-term outcomes
Up to 6 months
Participant Groups
This trial tests the FlowTriever System plus standard blood thinners against blood thinners alone in treating intermediate-risk acute PE. Participants will be randomly assigned to one of these two approaches to compare effectiveness and safety.
2Treatment groups
Active Control
Group I: FlowTrieverActive Control1 Intervention
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
Group II: AnticoagulationActive Control1 Intervention
Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Anticoagulants are a group of medications that decrease your blood's ability to clot.
Anticoagulation Agents is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Various Anticoagulants for:
- Atrial fibrillation
- Deep vein thrombosis (DVT)
- Pulmonary embolism
- Stroke prevention
🇺🇸 Approved in United States as Various Anticoagulants for:
- Atrial fibrillation
- Deep vein thrombosis (DVT)
- Pulmonary embolism
- Stroke prevention
- Hip or knee replacement surgery
🇨🇦 Approved in Canada as Various Anticoagulants for:
- Atrial fibrillation
- Deep vein thrombosis (DVT)
- Pulmonary embolism
- Stroke prevention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Virtua HealthCamden, NJ
University of Rochester Medical CenterRochester, NY
Nebraska Medical CenterOmaha, NE
AdventHealth OrlandoOrlando, FL
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.
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.
Association of type of oral anticoagulation with risk of bleeding in 45,114 patients with venous thromboembolism during initial and extended treatment-A nationwide register-based study. [2023]Safety data for different anticoagulant medications in venous thromboembolism (VTE) are scarce, in particular for extended treatment.