Efficacy and Safety of Novel Multi-Lumen Catheter for Chronic Total Occlusions: From Preclinical Study to First-in-Man Experience Yoshiaki Mitsutake, 1 MD, Adrian Ebner, 2 MD, Alan C. Yeung, 1 MD, Mark D. Taber, 3 MD, Charles J. Davidson, 4 MD, and Fumiaki Ikeno, 1 * MD Objective: To report our initial animal and human experience with a new multi-lumen catheter called MultiCross TM (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 5) were enrolled. After an initial unsuccessful attempt using a conventional guidewire, operators could use the MultiCross system. The pri- mary efficacy endpoint was successful recanalization (technical success) and the pri- mary 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. V C 2014 Wiley Periodicals, Inc. Key words: coronary artery disease; percutaneous coronary intervention; interventional devices/innovation INTRODUCTION Chronic total occlusions (CTOs) remain the most challenging lesion subset in percutaneous coronary inter- vention (PCI). Failure to cross with the guidewire is one of the major causes of procedural failure in CTO PCI [1]. The MultiCross catheter (Roxwood Medical Inc., Redwood City, CA) is designed to improve antegrade re- canalization success. We evaluated the efficacy and safety of this novel system in a porcine coronary model and in a consecutive series of patients with a CTO. MATERIALS AND METHODS Catheter System The MultiCross catheter is a 7-Fr guiding catheter compatible device (Fig. 1). The MultiCross catheter provides two key attributes. The first is an over-the- wire catheter with a triple-lumen design (Fig. 1), which allows for three separate and centered access ports to the CTO microchannels. The second is a temporary, resheathable self-expanding Nitinol anchor (Fig. 1), which is deployed proximal to the occlusion to provide additional support for advancement of the guidewire. The proximity of the anchored support lumens to the proximal cap of the occlusion also increases the pene- tration force of the guidewire into the true lumen. Preclinical Safety Study Animal research was approved by the institutional review board and animal care and use committees. Four female Yorkshire swine (8- to 12-weeks old, 30– 50 kg) were premedicated and anesthetized via an 1 Division of Cardiovascular Medicine, Stanford University, Stanford, California 2 Cardiovascular Department, Italian Hospital, Asunci  on, Paraguay 3 SSM Heart Institute, St. Joseph Health Center, St. Charles, Missouri 4 Division of Cardiology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois Conflict of interest: Dr. Fumiaki Ikeno-consultant Roxwood Medi- cal; Dr. Mark Taber-Advisor Roxwood Medical; Dr. Charles J. Davidson-Advisor Roxwood Medical. *Correspondence to: Fumiaki Ikeno, MD, Division of Cardiovascu- lar Medicine, Stanford University, FALK Cardiovascular Research Building, 300 Pasteur Drive, Stanford, CA 94305-5406. E-mail: fikeno@stanford.edu Received 1 May 2014; Revision accepted 15 October 2014 DOI: 10.1002/ccd.25711 Published online 20 October 2014 in Wiley Online Library (wileyonlinelibrary.com) V C 2014 Wiley Periodicals, Inc. Catheterization and Cardiovascular Interventions 85:E70–E75 (2015)