Actively Recruiting
Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
Led by Innova Vascular, Inc. · Updated on 2025-10-02
107
Participants Needed
14
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older and younger than 85 years
- RV/LV ratio greater than 0.9 as determined by CT angiography
- Systolic blood pressure greater than 90 mmHg
- Heart rate of 120 beats per minute or less
- Patient is considered eligible for the procedure by the interventional investigator
- CT angiography evidence of proximal pulmonary embolism (clot in at least one main or lobar pulmonary artery)
- Pulmonary embolism symptoms duration of 14 days or less
You will not qualify if you...
- Systolic pulmonary artery pressure greater than 70 mmHg on initial invasive hemodynamic assessments
- Life expectancy less than 90 days at the time of enrollment
- Pregnant or breastfeeding
- Currently participating in another drug or medical device treatment study
- Receiving active chemotherapy or radiation for cancer during the study
- Received any intravascular fibrinolytic agent (such as Alteplase or Tenecteplase) within the last 30 days
- Recently placed intracardiac devices (within less than 8 weeks) in the right ventricle or right atrium
- History of pulmonary embolism within the past 90 days
- Requires more than 40% oxygen (6 liters per minute) to maintain oxygen saturation above 90%
- Hematocrit below 28%
- Platelet count below 100,000 per microliter
- Serum creatinine above 2 mg/dL
- International Normalized Ratio (INR) above 3
- Major trauma Injury Severity Score greater than 15
- Cardiovascular or pulmonary surgery within the last 7 days
- Known bleeding disorder that cannot be managed with anticoagulation
- History of severe or chronic pulmonary arterial hypertension
- History of chronic left heart disease with ejection fraction below 30%
- History of oxygen-dependent lung disease
- History of chest irradiation
- Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- Any absolute contraindication to systemic or therapeutic heparin or anticoagulants
- Imaging or clinical evidence indicating the patient is unsuitable for mechanical thrombectomy
- Known presence of clot in transit within right atrium or ventricle
AI-Screening
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Trial Site Locations
Total: 14 locations
1
University of California Irvine
Irvine, California, United States, 92697
Actively Recruiting
2
Memorial Care Long Beach Medical Center
Long Beach, California, United States, 90806
Actively Recruiting
3
Mission Hospital Regional Medical Center
Mission Viejo, California, United States, 92691
Actively Recruiting
4
St. Joseph Hospital of Orange
Orange, California, United States, 92868
Actively Recruiting
5
George Washington University
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
6
Manatee Memorial Hospital
Bradenton, Florida, United States, 34209
Actively Recruiting
7
AdventHealth Tampa
Tampa, Florida, United States, 33613
Actively Recruiting
8
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
9
Albany Medical Center
Albany, New York, United States, 12210
Actively Recruiting
10
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
11
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
12
Hacettepe University Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
13
Sancaktepe Sehit Prof. Dr. Ilhan Varan Training and Research Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
14
Dokuz Eylul University Research and Application Hospital
Izmir, Turkey (Türkiye)
Actively Recruiting
Research Team
S
Sanjay Shrivastava, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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