A Next-Generation Guide Extension System for Percutaneous Coronary Intervention.

Background: Guide catheter extension is an integral part of percutaneous coronary intervention (PCI). First generation guide catheter extension devices are monorail, blunt ended tubular structures with limitations. The CrossLiner™ is a next generation guide extension "system" intended to allow safe, deep, coronary intubation.

Methods: The CrossLiner was tested in a head-to-head study with the GuideLiner™ and GuideZilla™ in a porcine coronary model, with stenting. Data were collected from 8 coronary vessels from four animals, to evaluate the ability to deeply intubate the vessel with the guide extension.

Results: The CrossLiner crossed distally and through a distal stented segment in 8/8 vessels, while the first-generation devices were stuck proximal to the stent (n=2/8) or at the stent edge (n=4/8), or passed partially into the deployed stent with difficulty (2/8) vessels (p < 0.0002 for deliverability). The average depth of guide extension delivery/ "intubation" was 12.9±3.6 cm for the CrossLiner and 5.6±1.1 cm for the first-generation guide extension (p < 0.001).

Conclusions: The CrossLiner is a next generation guide extension system that may offer advantages over first generation devices. Further clinical evaluation will be required to assess the role of this new device in PCI.