Status:
RECRUITING
Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
Lead Sponsor:
Innova Vascular, Inc.
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18-85 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
August 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT06041594
Start Date
August 19 2024
End Date
April 1 2026
Last Update
October 2 2025
Active Locations (14)
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1
University of California Irvine
Irvine, California, United States, 92697
2
Memorial Care Long Beach Medical Center
Long Beach, California, United States, 90806
3
Mission Hospital Regional Medical Center
Mission Viejo, California, United States, 92691
4
St. Joseph Hospital of Orange
Orange, California, United States, 92868