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Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

RecruitingNAAges 18 Years - 85 YearsAllInnova Vascular, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. ≥ 18 years of age; \< 85 years old 2. RV/LV ratio \> 0.9 as determined by CTA 3. Systolic blood pressure \> 90 mmHg 4. Heart rate ≤ 120 5. Patient is deemed eligible for procedure by the interventional investigator 6. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery) 7. PE Symptom duration ≤ 14 days Exclusion Criteria: 1. Systolic pulmonary artery pressure \> 70 mmHg on initial invasive hemodynamic assessments 2. Life expectancy of \< 90 days in the opinion of investigator at the time of enrollment 3. Subject pregnant or breast feeding 4. Current participation in another drug or medical device treatment study 5. In active chemotherapy or radiation treatment for a malignancy during the course of the study 6. Any intravascular administration of a fibrinolytic agent (such as Alteplase or Tenecteplase) within the last 30 days 7. Presence of recently placed (\<8 weeks) intracardiac devices (such as pacemaker leads) in the right ventricle or right atrium 8. History of prior PE within the past 90 days 9. FiO2 Requirement: \> 40% (6 LPM) to keep oxygen saturation \> 90% 10. Hematocrit: \< 28% 11. Platelets: \< 100,000/microliter 12. Serum Creatinine: \> 2 mg/dL 13. International Normalized Ratio (INR): \> 3 14. Major Trauma Injury Severity Score (ISS): \> 15 15. Cardiovascular or pulmonary surgery within the last 7 days 16. Known bleeding diathesis or coagulation disorder that cannot be managed with anti-coagulation 17. History of known severe or chronic pulmonary arterial hypertension 18. History or chronic left heart disease with left ventricular ejection fraction \< 30% 19. History of underlying lung disease that is oxygen dependent 20. History of chest irradiation 21. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 22. Any absolute contraindication to systemic or therapeutic dosage of heparin or anticoagulants 23. 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) 24. Known presence of clot in transit within right atrium or ventricle
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What it tests

  • Laguna Thrombectomy System
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Where

21 sites
Grandview Medical Center
Birmingham, United States
University of Arizona
Tucson, United States
University of California Irvine
Irvine, United States
Memorial Care Long Beach Medical Center
Long Beach, United States
Mission Hospital Regional Medical Center
Mission Viejo, United States
St. Joseph Hospital of Orange
Orange, United States
George Washington University
Washington D.C., United States
Manatee Memorial Hospital
Bradenton, United States

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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