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

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: Recruiting
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: Laguna Thrombectomy System

• Study Type: Interventional
• Enrollment (Estimated): 107
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanjay Shrivastava, Ph.D.; Phone Number: 949-295-6040; Email: ss@innovavascular.com

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Recruiting
    • Ankara Bilkent City Hospital
  • Ankara, Turkey (Türkiye)
    • Recruiting
    • Hacettepe University Hospital
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Sancaktepe Sehit Prof. Dr. Ilhan Varan Training and Research Hospital
  • Izmir, Turkey (Türkiye)
    • Recruiting
    • Dokuz Eylül University Research and Application Hospital
• United States
  • 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
    • Tampa, Florida, United States, 33613
      • Recruiting
      • AdventHealth Tampa
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
  • New York
    • Albany, New York, United States, 12210
      • Recruiting
      • Albany Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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/orCardiac 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)

Collaborators and Investigators

• Sponsor: Innova Vascular, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Pulmonary Embolism; Laguna Thrombectomy System
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: CIP-001 Rev. C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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