title: Efficacy and Safety of Novel NovaCross Microcatheter for Chronic Total Occlusions: First-in-Human Study.
abstract: OBJECTIVE
  The aim of this first-in-human (FIH) study was to evaluate the efficacy and safety of the novel NovaCross microcatheter system in eligible consecutive patients with chronic total occlusion (CTO).
  
  
  BACKGROUND
  CTOs remain the most challenging lesion subset in percutaneous coronary intervention (PCI). Failure to cross to the distal true lumen with the guidewire is one of the major causes of procedural failure in CTO-PCI. The NovaCross microcatheter (Nitiloop, Ltd) is designed to improve antegrade recanalization success.
  
  
  METHODS
  This study was a prospective, non-randomized, FIH investigational study. Patients with total occlusion of a coronary artery determined to be more than 3 months old and accepted for coronary CTO-PCI with an intended antegrade strategy were enrolled.
  
  
  RESULTS
  Twenty-four patients were enrolled in this study. Despite the high complexity of the lesions (including 80% J-CTO score ≥3 and 50% of the cases having had a previous failed CTO-PCI attempt), technical success was 81.8%. No patients reported any major adverse cardiac event up to and including 30 days post procedure.
  
  
  CONCLUSIONS
  In this FIH study, the NovaCross microcatheter exhibited the potential to stabilize guidewires and enhance crossing of coronary CTO lesions.
authors.affiliation: Belfast Health & Social Care Trust, Cardiology, Belfast, Ireland. Simon.Walsh@belfasttrust.hscni.net.
authors.forename: Simon
authors.initials: S
authors.lastname: Walsh
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Leszek
authors.initials: L
authors.lastname: Bryniarski
authors.forename: Abid
authors.initials: A
authors.lastname: Assali
authors.forename: Haim
authors.initials: H
authors.lastname: Danenberg
authors.forename: Chaim
authors.initials: C
authors.lastname: Lotan
authors.forename: Colm
authors.initials: C
authors.lastname: Hanratty
authors.forename: Piotr
authors.initials: P
authors.lastname: Wilkołek
authors.forename: Ran
authors.initials: R
authors.lastname: Kornowski
mesh_terms: D000368:Aged; D062906:Cardiac Catheters; D002908:Chronic Disease; D017023:Coronary Angiography; D054059:Coronary Occlusion / Q000175:diagnosis / Q000601:surgery*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D011446:Prospective Studies; D012307:Risk Factors