New balloon could open blocked heart arteries without a stent

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All patients must provide written informed consent. * Patients aged ≥18 years with coronary artery disease in whom, at the operator's discretion, treatment of a coronary stenosis in a native vessel (either de novo lesion or in-stent restenosis) or in a coronary bypass graft using the cSCB is indicated, in accordance with routine clinical practice. * All treated lesions/segments (single or tandem) must receive cSCB therapy covering at least 3 mm beyond both edges of the lesion or pre-dilated segment to avoid geographic miss. * In patients with multivessel coronary artery disease, all non-target vessels will be treated according to operator discretion: a) If more than one vessel is treated with the investigational device (SeQuent® SCB), all vessels will be documented and analyzed separately. b) Only one lesion per vessel will be included unless lesions are separated by ≥20 mm. c) Only one lesion per vessel will be included. d) If more than one lesion in the target vessel requires treatment, all lesions treated with a device different from the investigational procedure or with a device other than the investigational device (SeQuent® SCB) must be separated from the target lesion by ≥20 mm or considered as a single treated lesion according to this study protocol. Exclusion Criteria: * Explicit refusal by the patient to participate in the study. * Known intolerance to sirolimus or to any component of the investigational device. * Contraindication to any antiplatelet therapy. * Life expectancy less than 12 months. * Indication for surgical coronary revascularization. * Pregnancy or breastfeeding. * Clinical characteristics considered unsuitable for drug-coated balloon use at the operator's discretion, including: a) Hemorrhagic diathesis or other conditions such as gastrointestinal ulceration or cerebrovascular disorders restricting the use of antiplatelet therapy. b) Cardiogenic shock. c) Patients with left ventricular ejection fraction \<30% without the use of a ventricular assist device during PCI. Angiographic exclusion criteria * Reference vessel diameter \<2.00 mm or \>4.0 mm. * Treatment of the left main coronary artery. * Lesions not amenable to PCI or other interventional techniques. * Coronary artery spasm in the absence of significant stenosis. * Target lesion not suitable for drug-coated balloon-only PCI at the operator's discretion, including: a) Aorto-ostial lesions. b) Lesions with significant persistent residual thrombotic content visible in the vessel despite thromboaspiration. c) Treatment shortly after myocardial infarction with evidence of thrombus or impaired coronary flow.