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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
107
Removal of clot using the Laguna Thrombectomy System to treat Pulmonary Embolism
University of California Irvine
Irvine, California, United States
RECRUITINGMemorial Care Long Beach Medical Center
Long Beach, California, United States
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
Time frame: 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)
Time frame: from baseline to 48 (± 8) hours (or at discharge, whichever occurs first)
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Mission Hospital Regional Medical Center
Mission Viejo, California, United States
RECRUITINGSt. Joseph Hospital of Orange
Orange, California, United States
RECRUITINGGeorge Washington University
Washington D.C., District of Columbia, United States
RECRUITINGManatee Memorial Hospital
Bradenton, Florida, United States
RECRUITINGAdventHealth Tampa
Tampa, Florida, United States
RECRUITINGRush University Medical Center
Chicago, Illinois, United States
RECRUITINGAlbany Medical Center
Albany, New York, United States
RECRUITINGUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITING...and 4 more locations