Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

Not Applicable

Recruiting

• Conditions: Pulmonary Embolism
• Interventions: Device: Laguna Thrombectomy System

• Registration Number: NCT06041594
• Lead Sponsor: Innova Vascular, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-11
• Study First Posted: 2023-09-18
• Study Start: 2024-08-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laguna Thrombectomy System	Laguna Thrombectomy System	-

Primary Outcome Measures

Name	Time	Method
A composite of the following major adverse events occurring within 48 (± 8) hours post-procedure:	within 48 (± 8) hours post-procedure	* Device-related death within 48 (± 8) hours post-procedure; * Major bleeding as defined by GUSTO (moderate or severe) within 48 (± 8) hours post-procedure.; * The following treatment-related adverse events within 48 (± 8) hours post-procedure: * Cardio-respiratory deterioration,; * Pulmonary vascular injury, and/or; * Cardiac injury
Reduction in RV/LV ratio from baseline to 48 (± 8) hours (or at discharge, whichever occurs first) as assessed by Computed Tomography Angiography (CTA)	from baseline to 48 (± 8) hours (or at discharge, whichever occurs first)

Trial Locations

Locations (14)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey

Dokuz Eylul University Research and Application Hospital; 🇹🇷 Izmir, Turkey

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, 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

Hacettepe University Hospital; 🇹🇷 Ankara, Turkey

Sancaktepe Sehit Prof. Dr. Ilhan Varan Training and Research Hospital; 🇹🇷 Istanbul, Turkey