Clinical trial NCT06041594: Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
Official title: Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Laguna Thrombectomy System
Pulmonary Embolism
Lead sponsor: Innova Vascular, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-18
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: A composite of the following major adverse events occurring within 48 (± 8) hours post-procedure:
timeFrame: within 48 (± 8) hours post-procedure
measure: Reduction in RV/LV ratio from baseline to 48 (± 8) hours (or at discharge, whichever occurs first) as assessed by Computed Tomography Angiography (CTA)
timeFrame: from baseline to 48 (± 8) hours (or at discharge, whichever occurs first)
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Long Beach
country: United States
facility: Memorial Care Long Beach Medical Center
state: California
city: Mission Viejo
country: United States
facility: Mission Hospital Regional Medical Center
state: California
city: Orange
country: United States
facility: St. Joseph Hospital of Orange
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Hospital
city: Istanbul
country: Turkey
facility: Sancaktepe Sehit Prof. Dr. Ilhan Varan Training and Research Hospital
city: Izmir
country: Turkey
facility: Dokuz Eylul University Research and Application Hospital
Study officials:
References: