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Efficacy and safety of novel multi‐lumen catheter for chronic total occlusions
Author(s) -
Mitsutake Yoshiaki,
Ebner Adrian,
Yeung Alan C.,
Taber Mark D.,
Davidson Charles J.,
Ikeno Fumiaki
Publication year - 2015
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.25711
Subject(s) - medicine , catheter , lumen (anatomy) , clinical endpoint , adverse effect , surgery , occlusion , coronary artery disease , randomized controlled trial
Objective 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). Methods 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. Results 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. Conclusion In this first‐in‐man experience, the MultiCross catheter has the potential to enhance crossing of CTOs. © 2014 Wiley Periodicals, Inc.