TriNav pressure-enabled infusion catheter (pressure-modulated delivery) for Y-90 resin microspheres

Stanford University’s PRESSURE trial is a prospective, randomized, within-patient study testing whether pressure-modulated intra-arterial delivery improves Y-90 resin microsphere deposition in liver metastases compared with a standard end-hole microcatheter. Each participant must have at least two planned hepatic delivery sites (angiosomes) with the same intended mean tumor dose and at least one RECIST-measurable tumor in each territory; on treatment day, one territory is randomized to standard end-hole delivery and the other to the TriNav Infusion System. The device concept (TriNav; made by TriSalus Life Sciences) is pressure-enabled delivery intended to reduce reflux and improve downstream penetration/coverage, while the comparator is conventional end-hole microcatheter technique. Post-treatment Y-90 PET/CT dosimetry is used to compare tumor absorbed dose and tumor-to-normal liver deposition, with MRI at ~3 and ~6 months to assess response by RECIST/mRECIST. For many patients with liver-dominant metastatic disease, today’s care is systemic therapy by primary tumor type, with selected cases receiving liver-directed therapy such as Y-90 radioembolization, TACE, ablation, and/or surgery; this study focuses on optimizing the delivery physics rather than changing the radionuclide.