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
Grandview Medical Center
Birmingham, Alabama, 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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University of Arizona
Tucson, Arizona, United States
RECRUITINGUniversity of California Irvine
Irvine, California, United States
RECRUITINGMemorial Care Long Beach Medical Center
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RECRUITINGSt. Joseph Hospital of Orange
Orange, California, United States
RECRUITINGGeorge Washington University
Washington D.C., District of Columbia, United States
RECRUITINGManatee Memorial Hospital
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RECRUITINGPhysicians Regional Medical Center
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RECRUITINGAdventHealth Tampa
Tampa, Florida, United States
COMPLETED...and 11 more locations