RecruitingPulmonary Embolism
Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
Eligible age
18–85 yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Innova Vascular, Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
California
Irvine · Long Beach · Mission Viejo · Orange
District of Columbia
Washington D.C.
Florida
Bradenton · Tampa
Illinois
Chicago
New York
Albany
North Carolina
Chapel Hill
Source: ClinicalTrials.gov · NCT06041594 · last updated 2025-10-02