Pulmonary EmbolismTRUSTNCT06041594
Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
A study testing Laguna Thrombectomy System in people with Pulmonary Embolism, run by Innova Vascular, Inc. at 21 sites in 2 countries.
Trial 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™… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Laguna Thrombectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 19 Aug 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 2 countries
United States16 sites, 13 recruiting
- Completed
Albany Medical Center
Albany, New York, 12210
- Recruiting
Grandview Medical Center
Birmingham, Alabama, 35243
- Recruiting
Manatee Memorial Hospital
Bradenton, Florida, 34209
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
- Completed
Rush University Medical Center
Chicago, Illinois, 60612
- Recruiting
OhioHealth Research Institute
Columbus, Ohio, 43214
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
- Recruiting
University of California Irvine
Irvine, California, 92697
- Recruiting
Turkey Creek Medical Center
Knoxville, Tennessee, 37934
- Recruiting
Memorial Care Long Beach Medical Center
Long Beach, California, 90806
- Recruiting
Mission Hospital Regional Medical Center
Mission Viejo, California, 92691
- Recruiting
Physicians Regional Medical Center
Naples, Florida, 34119
- Recruiting
St. Joseph Hospital of Orange
Orange, California, 92868
- Completed
AdventHealth Tampa
Tampa, Florida, 33613
- Recruiting
University of Arizona
Tucson, Arizona, 85724
- Recruiting
George Washington University
Washington D.C., District of Columbia, 20037
Turkey (Türkiye)5 sites
- Completed
Ankara Bilkent City Hospital
Ankara
- Completed
Ankara Etlik City Hospital
Ankara
- Completed
Hacettepe University Hospital
Ankara
- Completed
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Istanbul
- Completed
Dokuz Eylul University Research and Application Hospital
Izmir
About this study
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
- Pulmonary Embolism
- Being tested
- Laguna Thrombectomy System
- Keywords
- Laguna Thrombectomy System, Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laguna Thrombectomy SystemDevice
Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism
| Study group | Role | What they receive |
|---|---|---|
| Laguna Thrombectomy System | Experimental | Not described Receives: Device: Laguna Thrombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: from baseline to 48 (± 8) hours (or at discharge, whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start19 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innova Vascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041594
- Sponsor's protocol ID
- CIP-001 Rev. C
- Acronym
- TRUST
- Status last verified
- Jul 2026
- First submitted
- 11 Sep 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
- ClinicalTrials.gov ID
- NCT06041594
- Acronym / sponsor ID
- TRUST / CIP-001 Rev. C
- Conditions
- Pulmonary Embolism
- Keywords
- Laguna Thrombectomy System, Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Innova Vascular, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laguna Thrombectomy System | Experimental | Device: Laguna Thrombectomy System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laguna Thrombectomy SystemRemoval of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism | Device | Laguna Thrombectomy System |
Primary outcome
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laguna Thrombectomy System in people with Pulmonary Embolism, run by Innova Vascular, Inc. at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanjay Shrivastava, Ph.D. (949-295-6040, ss@innovavascular.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of the following major adverse events occurring within 48 (± 8) hours post-procedure: (time frame: within 48 (± 8) hours post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.