Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease

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.
• •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.