Overview
This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion.
Description
There is lots of evidence that DCBs result in lower rates of restenosis, thrombosis, and better long-term outcomes when used for PCI of in-stent restenosis (ISR) compared to plain old balloon angioplasty (POBA) or additional stenting with drug-eluting stent (DES). DCB-only approach studies for de novo coronary lesion cases are scarce, but a recent registry data suggested it was a feasible and well-tolerated treatment method if the pre-dilation result is good. Therefore, the aim of this study was to evaluate the safety and efficacy in terms of angiographic and clinical outcomes of a DCB-only approach for de novo coronary lesions.
Eligibility
Inclusion Criteria:
- de novo coronary artery disease
Exclusion Criteria:
- unstable hemodynamics at presentation
- life expectancy <1 year