Treatment of pulmonary embolism using the Laguna Thrombectomy System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Laguna Thrombectomy System, which includes the Laguna Clot Retriever™ and Malibu Aspiration Catheter™ systems, for treating pulmonary embolism. It is a prospective, multi-center study that aims to gather data on the device's performance in patients diagnosed with proximal pulmonary embolism. Eligible participants will undergo the procedure under the supervision of interventional investigators, with a focus on those experiencing symptoms for 14 days or less.

Why it matters

Who can join: the full rules

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

Where it's running

• Grandview Medical Center
  Birmingham, Alabama, United States Recruiting
• University of Arizona
  Tucson, Arizona, United States Recruiting
• University of California Irvine
  Irvine, California, United States Recruiting
• Memorial Care Long Beach Medical Center
  Long Beach, California, United States Recruiting
• Mission Hospital Regional Medical Center
  Mission Viejo, California, United States Recruiting
• St. Joseph Hospital of Orange
  Orange, California, United States Recruiting

Study contacts

• Study coordinator: Sanjay Shrivastava, Ph.D.
• Email: ss@innovavascular.com
• Phone: 949-295-6040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.