Results from the GPX IDE Pivotal Clinical Trial (Evaluation of a Simple-Prep Controlled Embolic)

Distal embolization is desired for many embolic applications. In an IDE pivotal trial, a novel liquid embolic was used in both durable and pre-operative distal embolization procedures. The material deeply penetrates distally-flowing vessels, reaching vessels less than 20 microns in pre-clinical studies. The objective of the IDE study was to evaluate the safety and effectiveness of the embolic when used for distal embolization in 114 subjects across 20 investigational sites in the USA, New Zealand, and Canada.

Materials and Methods:

The investigation was a single-arm, open-label, non-randomized, prospective, multicenter, multinational pivotal study. Subjects underwent peripheral vasculature embolization using the GPX Embolic Device (Fluidx Medical Technology; Salt Lake City, Utah), including vascular tumors, renal embolizations, and portal vein branches. Subjects were followed for 30-days. Primary outcomes included freedom from major adverse events (MAEs), and successful delivery of the material and occlusion of flow beyond the target vessel embolization site. Secondary outcomes include occurrence of device related adverse events (AEs) through 30 days post-index procedure and occurrence of catheter occlusion due to the material.

Results:

At the time of abstract submission, 110/114 subjects have been enrolled at 18 sites, with 101/114 having completed the 30-day follow-up. Conditions for treatment include vascular tumors (renal angiomyolipoma, renal cell carcinoma, bone tumors, pelvic and abdominal tumors), portal vein branches, and renal embolizations. Successful occlusion of the target vessel(s) was observed in 95% of subjects. Fifty-two (52%) of subjects experienced an adverse event during the 30-day follow-up; 30% were procedure related and 10% were device related. The most common adverse event was post-embolization syndrome. No major adverse events or catheter occlusions due to the material have been reported.

Conclusion:

The trial is expected to meet both primary endpoints, demonstrating safety and efficacy with respect to the number of MAEs and successful occlusion of flow of the target vessel embolization sites.

The complete study cohort will be presented at the meeting.