Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
NCT ID: NCT06041594
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
107 participants
INTERVENTIONAL
2024-08-19
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Laguna Thrombectomy System
Laguna Thrombectomy System
Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism
Interventions
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Laguna Thrombectomy System
Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
85 Years
ALL
No
Sponsors
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Innova Vascular, Inc.
INDUSTRY
Responsible Party
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Locations
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University of California Irvine
Irvine, California, United States
Memorial Care Long Beach Medical Center
Long Beach, California, United States
Mission Hospital Regional Medical Center
Mission Viejo, California, United States
St. Joseph Hospital of Orange
Orange, California, United States
George Washington University
Washington D.C., District of Columbia, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
AdventHealth Tampa
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Albany Medical Center
Albany, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Hacettepe University Hospital
Ankara, , Turkey (Türkiye)
Sancaktepe Sehit Prof. Dr. Ilhan Varan Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University Research and Application Hospital
Izmir, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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CIP-001 Rev. C
Identifier Type: -
Identifier Source: org_study_id
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