Laguna Thrombectomy System: Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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
Primary outcome measure(s)
A composite of the following major adverse events occurring within 48 (± 8) hours post-procedure: — 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
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)
Trial sites (21)
Facility
City
Region
Status
Grandview Medical Center
Birmingham
Alabama
Recruiting
University of Arizona
Tucson
Arizona
Recruiting
University of California Irvine
Irvine
California
Recruiting
Memorial Care Long Beach Medical Center
Long Beach
California
Recruiting
Mission Hospital Regional Medical Center
Mission Viejo
California
Recruiting
St. Joseph Hospital of Orange
Orange
California
Recruiting
George Washington University
Washington D.C.
District of Columbia
Recruiting
Manatee Memorial Hospital
Bradenton
Florida
Recruiting
Physicians Regional Medical Center
Naples
Florida
Recruiting
AdventHealth Tampa
Tampa
Florida
Completed
Rush University Medical Center
Chicago
Illinois
Completed
Albany Medical Center
Albany
New York
Completed
University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
Recruiting
OhioHealth Research Institute
Columbus
Ohio
Recruiting
Turkey Creek Medical Center
Knoxville
Tennessee
Recruiting
University of Texas Southwestern
Dallas
Texas
Recruiting
Ankara Bilkent City Hospital
Ankara
Turkey (Türkiye)
Completed
Ankara Etlik City Hospital
Ankara
Turkey (Türkiye)
Completed
Hacettepe University Hospital
Ankara
Turkey (Türkiye)
Completed
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Istanbul
Turkey (Türkiye)
Completed
Dokuz Eylul University Research and Application Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.