Efficacy and Safety of Novel NovaCross Microcatheter for Chronic Total Occlusions: First-in-Human Study.

Objectives: 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.

Conclusion: In this FIH study, the NovaCross microcatheter exhibited the potential to stabilize guidewires and enhance crossing of coronary CTO lesions.