Pulmonary Embolism
Conditions
Keywords
Laguna Thrombectomy System, Pulmonary Embolism
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.
Interventions
DEVICELaguna Thrombectomy System
Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism
Sponsors
Innova Vascular, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A composite of the following major adverse events occurring within 48 (± 8) hours post-procedure: | within 48 (± 8) hours post-procedure | * Device-related death within 48 (± 8) hours post-procedure * Major bleeding as defined by GUSTO (moderate or severe) within 48 (± 8) hours post-procedure. * The following treatment-related adverse events within 48 (± 8) hours post-procedure: * Cardio-respiratory deterioration, * Pulmonary vascular injury, and/or * Cardiac injury |
| Reduction in RV/LV ratio from baseline to 48 (± 8) hours (or at discharge, whichever occurs first) as assessed by Computed Tomography Angiography (CTA) | from baseline to 48 (± 8) hours (or at discharge, whichever occurs first) | — |
Countries
Turkey (Türkiye), United States
Contacts
CONTACTSanjay Shrivastava, Ph.D.
Outcome results
None listed