NCT06041594 · Innova Vascular, Inc.
Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
(TRUST)
What this study is about
This is a forward-looking, 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 experimental device which consists of the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are manufactured by Innova Vascular, Inc.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥ 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
Exclusion criteria
- 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
- Irvine, California
- Long Beach, California
- Mission Viejo, California
- Orange, California
- Washington D.C., District of Columbia
- Bradenton, Florida
- Tampa, Florida
- Chicago, Illinois
- Albany, New York
- Chapel Hill, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2025 · Source of record for eligibility and locations