Stent under-expansion during percutaneous coronary intervention (PCI) is one of the
suboptimal results associated with a higher risk of restenosis and thrombosis. In order to
obtain an optimal stent expansion, especially in lesions with calcific or fibrotic plaque,
the appropriate lesion preparation before stent implantation is a crucial phase.
For this, different devices are used in everyday practices, including non-compliant balloon
(NC), scoring / cutting balloons or rotational atherectomy; however, their effectiveness
depends on the experience and skill of the operator. The purpose of this study is to assess
the feasibility, efficacy and safety of a novel scoring balloon intended to treat calcific or
fibrotic plaque of a coronary lesion