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Clinical Trials in the USA / NCT06041594
Recruiting Not applicable

Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

NCT06041594 · tracked via the Priya Life Science USA tracker
Sponsor
Innova Vascular, Inc.
Phase
Not applicable
Started
2024-08-19
Last updated
2026-07-17

Condition(s) studied

Pulmonary Embolism

Investigational drug(s) / intervention(s)

Laguna Thrombectomy System

Laguna Thrombectomy System: Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism

Study 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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Grandview Medical Center Birmingham Alabama Recruiting
University of Arizona Tucson Arizona Recruiting
University of California Irvine Irvine California Recruiting
Memorial Care Long Beach Medical Center Long Beach California Recruiting
Mission Hospital Regional Medical Center Mission Viejo California Recruiting
St. Joseph Hospital of Orange Orange California Recruiting
George Washington University Washington D.C. District of Columbia Recruiting
Manatee Memorial Hospital Bradenton Florida Recruiting
Physicians Regional Medical Center Naples Florida Recruiting
AdventHealth Tampa Tampa Florida Completed
Rush University Medical Center Chicago Illinois Completed
Albany Medical Center Albany New York Completed
University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
OhioHealth Research Institute Columbus Ohio Recruiting
Turkey Creek Medical Center Knoxville Tennessee Recruiting
University of Texas Southwestern Dallas Texas Recruiting
Ankara Bilkent City Hospital Ankara Turkey (Türkiye) Completed
Ankara Etlik City Hospital Ankara Turkey (Türkiye) Completed
Hacettepe University Hospital Ankara Turkey (Türkiye) Completed
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital Istanbul Turkey (Türkiye) Completed
Dokuz Eylul University Research and Application Hospital Izmir Turkey (Türkiye) Completed

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06041594 on ClinicalTrials.gov ↗ ← All trials in the USA