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

• ClinicalTrials.gov Identifier: NCT06041594
• Recruitment Status: Not yet recruiting
• First Posted: September 18, 2023
• Last Update Posted: March 12, 2024
• Sponsor: Innova Vascular, Inc.
• Information provided by (Responsible Party): Innova Vascular, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Embolism	Device: Laguna Thrombectomy System	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 107 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
• Estimated Study Start Date: May 2024
• Estimated Primary Completion Date: December 2024
• Estimated Study Completion Date: June 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Laguna Thrombectomy System	Device: Laguna Thrombectomy System; Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Sanjay Shrivastava, Ph.D.; 949-295-6040; ss@innovavascular.com

Sponsors and Collaborators

Innova Vascular, Inc.

More Information

• Responsible Party: Innova Vascular, Inc.
• ClinicalTrials.gov Identifier: NCT06041594
• Other Study ID Numbers: CIP-001 Rev. A
• First Posted: September 18, 2023
• Last Update Posted: March 12, 2024
• Last Verified: March 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Innova Vascular, Inc.:

Laguna Thrombectomy System; Pulmonary Embolism

Additional relevant MeSH terms:

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