title: Efficacy and safety of novel multi-lumen catheter for chronic total occlusions: from preclinical study to first-in-man experience.
abstract: 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.
  
  
  CONCLUSIONS
  In this first-in-man experience, the MultiCross catheter has the potential to enhance crossing of CTOs.
authors.affiliation: Division of Cardiovascular Medicine, Stanford University, Stanford, California.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Mitsutake
authors.forename: Adrian
authors.initials: A
authors.lastname: Ebner
authors.forename: Alan C
authors.initials: AC
authors.lastname: Yeung
authors.forename: Mark D
authors.initials: MD
authors.lastname: Taber
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Davidson
authors.forename: Fumiaki
authors.initials: F
authors.lastname: Ikeno
mesh_terms: D000368:Aged; D000818:Animals; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D002908:Chronic Disease; D017023:Coronary Angiography; D054059:Coronary Occlusion / Q000175:diagnosis / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D023421:Models, Animal; D012042:Registries; D013552:Swine; D013997:Time Factors; D016896:Treatment Outcome
keywords: coronary artery disease; interventional devices/innovation; percutaneous coronary intervention