Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
Innova Vascular, Inc.
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
- Age range
- 18–85 years
- Sex
- All
- 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 breas…
Interventions
- DeviceLaguna Thrombectomy System
Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism
Locations (14)
- University of California IrvineIrvine, California
- Memorial Care Long Beach Medical CenterLong Beach, California
- Mission Hospital Regional Medical CenterMission Viejo, California
- St. Joseph Hospital of OrangeOrange, California
- George Washington UniversityWashington D.C., District of Columbia
- Manatee Memorial HospitalBradenton, Florida