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

Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device (SeQuent® Sirolimus-Coated Balloon) in Patients With Coronary Artery Disease: A Prospective Observational Study

This prospective, multicenter, post-market observational study aims to evaluate the safety and effectiveness of the crystalline sirolimus-coated balloon (SeQuent® Sirolimus-Coated Balloon) for the treatment of coronary artery disease in routine clinical practice. Consecutive, unselected adult patients undergoing percutaneous coronary intervention for de novo coronary lesions or in-stent restenosis will be enrolled.

The primary objective is to assess target lesion failure at 12 months, defined as the composite of target vessel myocardial infarction or ischemia-driven target lesion revascularization. Secondary objectives include angiographic procedural success, major adverse cardiovascular events, bleeding outcomes, and longer-term clinical results up to 36 months, as well as outcomes across predefined anatomical and clinical subgroups.

The study seeks to answer whether treatment with the crystalline sirolimus-coated balloon provides a safe and effective revascularization strategy in a real-world population with diverse clinical presentations and lesion characteristics.

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.