Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

Recruiting now · Not applicable

Conditions studied: Pulmonary Embolism

In brief

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.

Key facts

Study ID

NCT06041594

Run by

Innova Vascular, Inc.

People needed

107

Starts

2024-08-19

Expected to finish

2026-09-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age; < 85 years old
• RV/LV ratio > 0.9 as determined by CTA
• Systolic blood pressure > 90 mmHg
• Heart rate ≤ 120
• Patient is deemed eligible for procedure by the interventional investigator
• CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
• PE Symptom duration ≤ 14 days

You may not qualify if…

• Systolic pulmonary artery pressure > 70 mmHg on initial invasive hemodynamic assessments
• Life expectancy of < 90 days in the opinion of investigator at the time of enrollment
• Subject pregnant or breast feeding
• Current participation in another drug or medical device treatment study
• In active chemotherapy or radiation treatment for a malignancy during the course of the study
• Any intravascular administration of a fibrinolytic agent (such as Alteplase or Tenecteplase) within the last 30 days
• Presence of recently placed (<8 weeks) intracardiac devices (such as pacemaker leads) in the right ventricle or right atrium
• History of prior PE within the past 90 days
• FiO2 Requirement: > 40% (6 LPM) to keep oxygen saturation > 90%
• Hematocrit: < 28%
• Platelets: < 100,000/microliter
• Serum Creatinine: > 2 mg/dL
• International Normalized Ratio (INR): > 3
• Major Trauma Injury Severity Score (ISS): > 15
• Cardiovascular or pulmonary surgery within the last 7 days
• Known bleeding diathesis or coagulation disorder that cannot be managed with anti-coagulation
• History of known severe or chronic pulmonary arterial hypertension
• History or chronic left heart disease with left ventricular ejection fraction < 30%
• History of underlying lung disease that is oxygen dependent
• History of chest irradiation
• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• Any absolute contraindication to systemic or therapeutic dosage of heparin or anticoagulants
• 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)
• Known presence of clot in transit within right atrium or ventricle

Where it is running

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

Full record on ClinicalTrials.gov

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