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NCT06041594NARecruiting

Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

Innova Vascular, Inc.

Start Date

8/19/2024

Completion Date

9/1/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to 85 years

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

Interventions

DEVICE

Laguna Thrombectomy System

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Conditions

Pulmonary Embolism

Locations

Grandview Medical Center

Birmingham, Alabama 35243

United States

University of Arizona

Tucson, Arizona 85724

United States

University of California Irvine

Irvine, California 92697

United States

Memorial Care Long Beach Medical Center

Long Beach, California 90806

United States

Mission Hospital Regional Medical Center

Mission Viejo, California 92691

United States

St. Joseph Hospital of Orange

Orange, California 92868

United States

George Washington University

Washington D.C., District of Columbia 20037

United States

Manatee Memorial Hospital

Bradenton, Florida 34209

United States

Physicians Regional Medical Center

Naples, Florida 34119

United States

AdventHealth Tampa

Tampa, Florida 33613

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

Albany Medical Center

Albany, New York 12210

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

OhioHealth Research Institute

Columbus, Ohio 43214

United States

Turkey Creek Medical Center

Knoxville, Tennessee 37934

United States

University of Texas Southwestern

Dallas, Texas 75390

United States

Ankara Bilkent City Hospital

Ankara,

Turkey (Türkiye)

Ankara Etlik City Hospital

Ankara,

Turkey (Türkiye)

Hacettepe University Hospital

Ankara,

Turkey (Türkiye)

Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital

Istanbul,

Turkey (Türkiye)

Dokuz Eylul University Research and Application Hospital

Izmir,

Turkey (Türkiye)