Selution Sirolimus Coated Balloon (MedAlliance) Versus SeQuent Please Neo Paclitaxel Coated Balloon (Bbraun) for the Treatment of de Novo Coronary Artery Lesions in Medium-small Size Vessels.
The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (\>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) and Fractional Flow Reserve (FFR) at 12 months follow-up.
• Male or female subjects ≥18 years
• Subject with chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values.
• The subject has at least one de-novo lesion in a small vessel (\>2.00 mm and ≤3.00 mm prior to pre-dilatation) with a diameter stenosis between 50% and 99% (prior to pre-dilatation). It is possible to enroll subjects that have a stent previously implanted in the same epicardial territory (main vessel and ramifications) of the target lesion
• Patients with target lesion to be treated with DCB \< 30 mm in length (up to 40 patients) or with DCB ≥ 30 mm in length (at least 100 patients)
• Able to understand and provide informed consent and comply with all study procedures including 12 months angiographic follow-up
• Subject must have completed the follow-up phase of any previous study