Comparing Sirolimus and Paclitaxel Coated Balloons for Treating New Coronary Artery Lesions in Medium-Small Vessels

What this Trial Is About

Researchers are comparing two types of drug-coated balloons, Selution sirolimus coated balloon and SeQuent Please Neo paclitaxel coated balloon, for treating new coronary artery lesions in medium-small vessels sized between greater than 2.00 mm and 3.00 mm. The study aims to evaluate differences in artery diameter improvement Net Gain and blood flow measurement Fractional Flow Reserve at 12 months after treatment. This multicenter, randomized study focuses on patients with small vessel coronary artery disease and stable or stabilized heart conditions. Participants will receive angioplasty using one of the two drug-coated balloons after successful lesion preparation. Patients are randomized 11 to either the sirolimus or paclitaxel balloon groups, stratified by balloon length less than 30 mm or 30 mm and longer. Other non-study lesions may be treated with standard devices if needed. Follow-ups include phone calls at 1 and 6 months, with an angiographic and blood flow assessment at 12 months at the original treatment center. During the study, participants will undergo imaging assessments before and after the procedure and at one year to measure artery narrowing and blood flow. Measurements include quantitative coronary angiography and fractional flow reserve. Dual antiplatelet therapy is required for at least one month post-procedure, followed by aspirin alone indefinitely. Researchers will monitor device and procedure success, heart-related events, and vessel health throughout the 12-month period.

SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective