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Recruiting NCT06041594

Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

No phase Interventional Pulmonary Embolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laguna Thrombectomy System.
Who it may be relevant to
Registry conditions: Pulmonary Embolism. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Laguna Thrombectomy System
    Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism

Primary outcome measures

  • A composite of the following major adverse events occurring within 48 (± 8) hours post-procedure: [Time frame: 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) [Time frame: from baseline to 48 (± 8) hours (or at discharge, whichever occurs first)]

Eligibility criteria

Inclusion 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 interventional investigator
  • CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
  • PE Symptom duration ≤ 14 days

Exclusion criteria

  • 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 clot or non-clot embolus)
  • Known presence of clot in transit within right atrium or ventricle

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 16 centers
  • Grandview Medical Center — Birmingham
  • University of Arizona — Tucson
  • University of California Irvine — Irvine
  • Memorial Care Long Beach Medical Center — Long Beach
  • Mission Hospital Regional Medical Center — Mission Viejo
  • St. Joseph Hospital of Orange — Orange
  • George Washington University — Washington D.C.
  • Manatee Memorial Hospital — Bradenton
  • … and 8 more centers
Turkey (Türkiye) · 5 centers
  • Ankara Bilkent City Hospital — Ankara
  • Ankara Etlik City Hospital — Ankara
  • Hacettepe University Hospital — Ankara
  • Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital — Istanbul
  • Dokuz Eylul University Research and Application Hospital — Izmir

Identifiers

NCT: NCT06041594 · CIP-001 Rev. C

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗