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New treatment option for Pulmonary Embolism
Official title Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
ClinicalTrials.gov ID: NCT06041594
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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 treatment investigator
You likely can't join 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
See the full eligibility criteria
- ≥ 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 treatment investigator
- CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
- PE Symptom duration ≤ 14 days
- 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
- Known bleeding diathesis or coagulation disorder that cannot be managed with anti-coagulation
- History of known severe or chronic pulmonary arterial hypertension
- History or chronic left heart disease with left ventricular ejection fraction \< 30%
- History of underlying lung disease that is oxygen dependent
- History of chest irradiation
- Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- Any absolute contraindication to systemic or therapeutic dosage of heparin or anticoagulants
- 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...
- Known presence of clot in transit within right atrium or ventricle
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Irvine, California, United States
- Long Beach, California, United States
- Mission Viejo, California, United States
- Orange, California, United States
- Washington D.C., District of Columbia, United States
- Bradenton, Florida, United States
- Naples, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Albany, New York, United States
- Chapel Hill, North Carolina, United States
- Columbus, Ohio, United States
- Knoxville, Tennessee, United States
- Dallas, Texas, United States
- Ankara, Turkey (Türkiye)
- Istanbul, Turkey (Türkiye)
- Izmir, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tucson, Arizona, United States; Irvine, California, United States; Long Beach, California, United States; Mission Viejo, California, United States; Orange, California, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.