Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

Study Overview
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Brief Summary
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This is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the Laguna Thrombectomy System for the treatment of pulmonary embolism. The Laguna Thrombectomy System is an investigational device which consists of the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are manufactured by Innova Vascular, Inc.

Official Title
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Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: Laguna Thrombectomy System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age; < 85 years old RV/LV ratio > 0.9 as determined by CTA Systolic blood pressure > 90 mmHg Heart rate ≤ 120 Patient is deemed eligible for procedure by the interventional investigator CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery) PE Symptom duration ≤ 14 days Exclusion Criteria: Systolic pulmonary artery pressure > 70 mmHg on initial invasive hemodynamic assessments Life expectancy of < 90 days in the opinion of investigator at the time of enrollment Subject pregnant or breast feeding Current participation in another drug or medical device treatment study In active chemotherapy or radiation treatment for a malignancy during the course of the study Any intravascular administration of a fibrinolytic agent (such as Alteplase or Tenecteplase) within the last 30 days Presence of recently placed (<8 weeks) intracardiac devices (such as pacemaker leads) in the right ventricle or right atrium History of prior PE within the past 90 days FiO2 Requirement: > 40% (6 LPM) to keep oxygen saturation > 90% Hematocrit: < 28% Platelets: < 100,000/microliter Serum Creatinine: > 2 mg/dL International Normalized Ratio (INR): > 3 Major Trauma Injury Severity Score (ISS): > 15 Cardiovascular or pulmonary surgery within the last 7 days Known bleeding diathesis or coagulation disorder that cannot be managed with anti-coagulation History of known severe or chronic pulmonary arterial hypertension History or chronic left heart disease with left ventricular ejection fraction < 30% History of underlying lung disease that is oxygen dependent History of chest irradiation Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated Any absolute contraindication to systemic or therapeutic dosage of heparin or anticoagulants Imaging or other evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominantly chronic clot or non-clot embolus) Known presence of clot in transit within right atrium or ventricle

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Laguna Thrombectomy System<br> | Device: Laguna Thrombectomy System<br>* Removal of clot using the Laguna 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 |
| --- | --- | --- |
| A composite of the following major adverse events occurring within 48 (± 8) hours post-procedure: | Device-related death within 48 (± 8) hours post-procedure Major bleeding as defined by GUSTO (moderate or severe) within 48 (± 8) hours post-procedure. The following treatment-related adverse events within 48 (± 8) hours post-procedure: Cardio-respiratory deterioration, Pulmonary vascular injury, and/or Cardiac injury | within 48 (± 8) hours post-procedure | 
| Reduction in RV/LV ratio from baseline to 48 (± 8) hours (or at discharge, whichever occurs first) as assessed by Computed Tomography Angiography (CTA) |  | from baseline to 48 (± 8) hours (or at discharge, whichever occurs first) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laguna Thrombectomy System, Pulmonary Embolism