Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

NCT06041594 | Recruiting DMC FDA Device

• 1 other identifier: CIP-001 Rev. C
• Study Type: interventional
• Target: 107
• Locations: 2 countries
• Sites: 14

Brief 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™ System. These devices are manufactured by Innova Vascular, Inc.

Conditions

Pulmonary Embolism

Keywords

Laguna Thrombectomy System; Pulmonary Embolism

Outcome Measures

Primary Outcomes (2)

• 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

  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)

Study Arms (1)

Laguna Thrombectomy System

EXPERIMENTAL

Device: Laguna Thrombectomy System

Interventions

Laguna Thrombectomy System DEVICE

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

Laguna Thrombectomy System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify 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
• 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

Sponsors & Collaborators

• Innova Vascular, Inc.: lead

Study Sites (14)

University of California Irvine

Irvine, California, 92697, United States

RECRUITING

Memorial Care Long Beach Medical Center

Long Beach, California, 90806, United States

RECRUITING

Mission Hospital Regional Medical Center

Mission Viejo, California, 92691, United States

RECRUITING

St. Joseph Hospital of Orange

Orange, California, 92868, United States

RECRUITING

George Washington University

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Manatee Memorial Hospital

Bradenton, Florida, 34209, United States

RECRUITING

AdventHealth Tampa

Tampa, Florida, 33613, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Albany Medical Center

Albany, New York, 12210, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Hacettepe University Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Sancaktepe Sehit Prof. Dr. Ilhan Varan Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Dokuz Eylul University Research and Application Hospital

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Sanjay Shrivastava, Ph.D.

CONTACT

949-295-6040; ss@innovavascular.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: August 19, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4); US (10)