Treatment of pulmonary embolism using the Laguna Thrombectomy System

Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

This study is testing a new device to see if it can safely and effectively treat pulmonary embolism in patients who have had symptoms for 14 days or less.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 107 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Innova Vascular, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 14 sites (Irvine, California and 13 other locations)
• Trial ID: NCT06041594 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Laguna Thrombectomy System, which includes the Laguna Clot Retriever™ and Malibu Aspiration Catheter™ systems, for treating pulmonary embolism. It is a prospective, multi-center study that aims to gather data on the device's performance in patients diagnosed with proximal pulmonary embolism. Eligible participants will undergo the procedure under the supervision of interventional investigators, with a focus on those experiencing symptoms for 14 days or less.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with a confirmed diagnosis of proximal pulmonary embolism and specific hemodynamic criteria.

Not a fit: Patients with severe pulmonary hypertension, recent malignancy treatments, or those currently participating in other clinical studies may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from pulmonary embolism.

How similar studies have performed: While this approach is investigational, similar thrombectomy techniques have shown promise in treating pulmonary embolism in previous studies.

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

Where this trial is running

Irvine, California and 13 other locations

• University of California Irvine — Irvine, California, United States (Recruiting)
• Memorial Care Long Beach Medical Center — Long Beach, California, United States (Recruiting)
• Mission Hospital Regional Medical Center — Mission Viejo, California, United States (Recruiting)
• St. Joseph Hospital of Orange — Orange, California, United States (Recruiting)
• George Washington University — Washington D.C., District of Columbia, United States (Recruiting)
• Manatee Memorial Hospital — Bradenton, Florida, United States (Recruiting)
• AdventHealth Tampa — Tampa, Florida, United States (Recruiting)
• Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
• Albany Medical Center — Albany, New York, United States (Recruiting)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
• Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye) (Recruiting)
• Hacettepe University Hospital — Ankara, Turkey (Türkiye) (Recruiting)
• Sancaktepe Sehit Prof. Dr. Ilhan Varan Training and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
• Dokuz Eylul University Research and Application Hospital — Izmir, Turkey (Türkiye) (Recruiting)

Study contacts

• Study coordinator: Sanjay Shrivastava, Ph.D.

Conditions Pulmonary Embolism; Laguna Thrombectomy System