Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

Launched by INNOVA VASCULAR, INC. · Sep 11, 2023

Keywords

ClinConnect Summary

The TRUST trial is studying a new device called the Laguna Thrombectomy System, which is designed to treat pulmonary embolism (PE), a serious condition where blood clots block blood flow in the lungs. This trial aims to show how safe and effective this system is in helping patients with PE. It is open for people aged 18 to 85 who have specific symptoms related to PE and meet certain health criteria, like having a certain heart function and blood pressure.

If you or a loved one qualifies to participate, you can expect to receive treatment using this investigational device, which includes two parts: a clot retrieval system and an aspiration catheter. Participants will be closely monitored throughout the study to ensure safety. It's important to note that some people may not be eligible due to existing health issues or recent treatments that could interfere with the trial. This study is currently recruiting, and interested individuals should discuss with their doctors to see if this might be a suitable option for them.

Gender

ALL

Eligibility criteria

• 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