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Efficacy and Safety of Novel Multi-Lumen Catheter for Chronic Total Occlusions: From Preclinical Study to First-in-Man Experience

Efficacy and Safety of Novel Multi-Lumen Catheter for Chronic Total Occlusions: From Preclinical Study to First-in-Man Experience CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS Mitsutake, Y., Ebner, A., Yeung, A. C., Taber, M. D., Davidson, C. J., Ikeno, F. 2015; 85 (3): E70-E75

Abstract

To report our initial animal and human experience with a new multi-lumen catheter called MultiCross™ (Roxwood Medical, Inc.) in a porcine coronary model and patients with a chronic total occlusion (CTO).Preclinical safety study was done in the coronary vasculature of a porcine model. In a clinical setting, patients with a CTO of a coronary artery (n = 5) were enrolled. After an initial unsuccessful attempt using a conventional guidewire, operators could use the MultiCross system. The primary efficacy endpoint was successful recanalization (technical success) and the primary safety endpoint was serious adverse events through 30 days post-procedure.The MultiCross catheter was used for all patients after failure of the initial attempt with a guidewire. Successful recanalization was achieved in all CTOs attempted (100%). No patients reported any adverse events at 30 days post-procedure.In this first-in-man experience, the MultiCross catheter has the potential to enhance crossing of CTOs.

View details for DOI 10.1002/ccd.25711

View details for Web of Science ID 000349962400002

View details for PubMedID 25331940