Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST) (TRUST)

July 16, 2026 updated by: Innova Vascular, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Completed
        • Ankara Bilkent City Hospital
      • Ankara, Turkey (Türkiye)
        • Completed
        • Ankara Etlik City Hospital
      • Ankara, Turkey (Türkiye)
        • Completed
        • Hacettepe University Hospital
      • Istanbul, Turkey (Türkiye)
        • Completed
        • Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
      • Izmir, Turkey (Türkiye)
        • Completed
        • Dokuz Eylul University Research and Application Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Recruiting
        • Grandview Medical Center
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona
    • California
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California Irvine
      • Long Beach, California, United States, 90806
        • Recruiting
        • Memorial Care Long Beach Medical Center
      • Mission Viejo, California, United States, 92691
        • Recruiting
        • Mission Hospital Regional Medical Center
      • Orange, California, United States, 92868
        • Recruiting
        • St. Joseph Hospital of Orange
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • Recruiting
        • George Washington University
    • Florida
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • Manatee Memorial Hospital
      • Naples, Florida, United States, 34119
        • Recruiting
        • Physicians Regional Medical Center
      • Tampa, Florida, United States, 33613
        • Completed
        • AdventHealth Tampa
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Completed
        • Rush University Medical Center
    • New York
      • Albany, New York, United States, 12210
        • Completed
        • Albany Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Research Institute
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Recruiting
        • Turkey Creek Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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

Exclusion Criteria:

  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
  9. FiO2 Requirement: > 40% (6 LPM) to keep oxygen saturation > 90%
  10. Hematocrit: < 28%
  11. Platelets: < 100,000/microliter
  12. Serum Creatinine: > 2 mg/dL
  13. International Normalized Ratio (INR): > 3
  14. Major Trauma Injury Severity Score (ISS): > 15
  15. Cardiovascular or pulmonary surgery within the last 7 days
  16. Known bleeding diathesis or coagulation disorder that cannot be managed with anti-coagulation
  17. History of known severe or chronic pulmonary arterial hypertension
  18. History or chronic left heart disease with left ventricular ejection fraction < 30%
  19. History of underlying lung disease that is oxygen dependent
  20. History of chest irradiation
  21. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
  22. Any absolute contraindication to systemic or therapeutic dosage of heparin or anticoagulants
  23. 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)
  24. Known presence of clot in transit within right atrium or ventricle

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Laguna Thrombectomy System
Device: Laguna Thrombectomy System
Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
A composite of the following major adverse events occurring within 48 (± 8) hours post-procedure:
Time Frame: 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)
Time Frame: from baseline to 48 (± 8) hours (or at discharge, whichever occurs first)
from baseline to 48 (± 8) hours (or at discharge, whichever occurs first)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innova Vascular, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP-001 Rev. C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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