Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
TRUST
1 other identifier
interventional
107
2 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2024
Typical duration for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2023
CompletedFirst Posted
Study publicly available on registry
September 18, 2023
CompletedStudy Start
First participant enrolled
August 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedJuly 17, 2026
July 1, 2026
2 years
September 11, 2023
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
A composite of the following major adverse events occurring 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
within 48 (± 8) hours post-procedure
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)
Study Arms (1)
Laguna Thrombectomy System
EXPERIMENTALInterventions
Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age; \< 85 years old
- RV/LV ratio \> 0.9 as determined by CTA
- Systolic blood pressure \> 90 mmHg
- Heart rate ≤ 120
- Patient is deemed eligible for procedure by the interventional investigator
- CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
- PE Symptom duration ≤ 14 days
You may not qualify if:
- Systolic pulmonary artery pressure \> 70 mmHg on initial invasive hemodynamic assessments
- Life expectancy of \< 90 days in the opinion of investigator at the time of enrollment
- Subject pregnant or breast feeding
- Current participation in another drug or medical device treatment study
- In active chemotherapy or radiation treatment for a malignancy during the course of the study
- Any intravascular administration of a fibrinolytic agent (such as Alteplase or Tenecteplase) within the last 30 days
- Presence of recently placed (\<8 weeks) intracardiac devices (such as pacemaker leads) in the right ventricle or right atrium
- History of prior PE within the past 90 days
- FiO2 Requirement: \> 40% (6 LPM) to keep oxygen saturation \> 90%
- Hematocrit: \< 28%
- Platelets: \< 100,000/microliter
- Serum Creatinine: \> 2 mg/dL
- International Normalized Ratio (INR): \> 3
- Major Trauma Injury Severity Score (ISS): \> 15
- Cardiovascular or pulmonary surgery within the last 7 days
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Grandview Medical Center
Birmingham, Alabama, 35243, United States
University of Arizona
Tucson, Arizona, 85724, United States
University of California Irvine
Irvine, California, 92697, United States
Memorial Care Long Beach Medical Center
Long Beach, California, 90806, United States
Mission Hospital Regional Medical Center
Mission Viejo, California, 92691, United States
St. Joseph Hospital of Orange
Orange, California, 92868, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Manatee Memorial Hospital
Bradenton, Florida, 34209, United States
Physicians Regional Medical Center
Naples, Florida, 34119, United States
AdventHealth Tampa
Tampa, Florida, 33613, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Albany Medical Center
Albany, New York, 12210, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
OhioHealth Research Institute
Columbus, Ohio, 43214, United States
Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye)
Hacettepe University Hospital
Ankara, Turkey (Türkiye)
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Istanbul, Turkey (Türkiye)
Dokuz Eylul University Research and Application Hospital
Izmir, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2023
First Posted
September 18, 2023
Study Start
August 19, 2024
Primary Completion
August 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
July 17, 2026
Record last verified: 2026-07