Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

Pulmonary Embolism Clinical Trial

— TRUST  

Official title:

Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06041594
• Other study ID #: CIP-001 Rev. A
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Innova Vascular, Inc.
• Contact: Sanjay Shrivastava, Ph.D.
• Phone: 949-295-6040
• Email: ss[@]innovavascular.com
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 107
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Innova Vascular, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)