The objective of this study is to evaluate the safety and effectiveness of the GPX® Embolic Device when used as indicated for embolization requiring distal vessel penetration in 114 subjects in up to 25 investigational sites in the USA, New Zealand, and Canada.
The investigation is a single-arm, open-label, non-randomized, prospective, multicenter, multinational pivotal study. Subjects will undergo distal embolization in the peripheral vasculature, including vascular tumors, renal embolizations, and portal vein branches, with the GPX® Embolic Device and will then be followed 30-days post-procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Treatment includes distal embolization in the peripheral vasculature of vascular tumors, renal embolization, and portal vein branches
University of California San Diego Altman Clinical and Translation Research Institute
La Jolla, California, United States
Freedom from major adverse events (MAEs)
MAEs are defined as: * Nontarget embolization with ischemia in an unintended anatomical area * Systemic allergic and/or toxic reaction to the GPX Embolic Device * Catheter entrapment and/or breakage * Culture-proven abscess in target organ/tissue * Embolization-related death
Time frame: Index procedure through 30-day follow-up
Single binomial proportion of successful delivery of the GPX Embolic Device to the target vessel embolization site(s)
Determined by the investigator at the time of enrollment
Time frame: During procedure
Single binomial proportion of successful occlusion of flow immediately beyond the target vessel embolization site(s)
Determined by the core lab via comparison of the pre- and final post-embolization images
Time frame: End of procedure
Occurrence of device-related adverse events (AE) through 30 days post-index procedure
Time frame: 30-day follow-up
Occurrence of adjunctive embolization agent usage during the embolization procedure
Time frame: End of procedure
Occurrence of catheter occlusion due to the GPX Embolic Material
Time frame: End of procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Northwestern University
Chicago, Illinois, United States
Indiana University Hospital
Indianapolis, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University - Barnes Jewish Hospital
St Louis, Missouri, United States
Albany Medical Center
Albany, New York, United States
Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
...and 10 more locations