Aventus Thrombectomy System Pulmonary Embolism Clinical Study

Study Overview
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Brief Summary
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Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.

Official Title
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Evaluate the Safety and Efficacy of the Aventus Thrombectomy System for Aspiration Thrombectomy in Subjects With Acute Pulmonary Embolism

Conditions
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Pulmonary Embolism, Embolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Lung Diseases, Respiratory Tract Diseases

Intervention / Treatment
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* Device: Thrombectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 and ≤ 80 years Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures Subject is willing and able to comply with all protocol required follow-up visits PE symptom(s) duration ≤ 14 days from index procedure PE diagnosis ≤ 48 hours prior to index procedure CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery based on Investigator determination) CTA evidence of dilated RV with an RV/LV ratio of ≥ 0.9 at baseline based on Investigator determination Systolic blood pressure ≥ 90 mmHg without need for vasopressors (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with intravenous fluids prior to index procedure) Stable heart rate < 130 BPM prior to index procedure Subject is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment Exclusion Criteria: Prior PE ≤ 180 days from index procedure Current hospitalization for other condition(s) Thrombolytic use ≤ 14 days of baseline CTA Pulmonary hypertension with peak pulmonary artery systolic pressure > 70 mmHg by right heart catheterization FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90% Hematocrit < 28% within 6 hours of index procedure Platelets < 100,000/μL Serum creatinine > 1.8 mg/dL International normalized ratio (INR) > 3 Presence of intracardiac lead in the right ventricle or right atrium placed < 180 days prior to index procedure Cardiovascular or pulmonary surgery ≤ 7 days prior to index procedure Actively progressing cancer treated by chemotherapeutics Known bleeding diathesis or coagulation disorder Left bundle branch block History of severe or chronic pulmonary arterial hypertension History of chronic left heart disease with left ventricular ejection fraction ≤ 30% History of uncompensated heart failure History of underlying lung disease that is oxygen dependent History of chest irradiation History of heparin-induced thrombocytopenia (HIT) Any contraindication to systemic or therapeutic doses of heparin or anticoagulants Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for aspiration thrombectomy intervention such as the inability to navigate to target location, predominantly chronic clot or non-clot embolus Life expectancy of < 90 days, as determined by Investigator Female who is pregnant or nursing Current participation in another investigational drug or device treatment study that has not reached the primary endpoint or the Investigator feels would impact their ability to participate in this clinical trial Subject has known residual Iliac Deep Vein Thrombosis (DVT), Inferior Vena Cava (IVC) clot or clot in transit (right atrium and/or right ventricular) Subject on extracorporeal membrane oxygenation (ECMO)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Device: Aventus Thrombectomy System | Device: Thrombectomy<br>* Use of Aventus Thrombectomy System to treat pulmonary embolism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in RV/LV Ratio | Change in RV/LV Ratio per CTA | From Baseline to 48 hours | 
| Major Adverse Event Rate | Composite of device related MAEs including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury | From Index Procedure to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Embolism, Clot, Thromboembolism, Thrombectomy, Right Heart Strain