Evaluation of the SELUTION SLR 014 Drug Eluting Balloon Versus FDA-Approved Drug-Eluting Stents for New Lesions in Small Coronary Arteries

What this Trial Is About

Researchers are evaluating the safety and efficacy of the SELUTION SLR 014 PTCA Drug Eluting Balloon DEB in treating new lesions in small coronary vessels, specifically those with a reference vessel diameter of 2.00 mm to 2.75 mm. This prospective, randomized controlled, single-blind, multicenter clinical trial aims to support a pre-market approval application to the US FDA. It involves participants with chronic coronary syndrome, unstable angina, or stabilized non-ST elevation myocardial infarction who require percutaneous coronary intervention PCI. Participants will be randomly assigned to one of two groups the experimental group receiving the SELUTION SLR 014 PTCA DEB with lesion preparation following recommended guidelines, or the control group treated with any FDA-approved limus-based drug-eluting stent DES according to standard practice. The study also includes an angiographic substudy with up to 30 additional participants undergoing angiography at 12 months, and a pharmacokinetic substudy with up to 20 participants involving regular blood draws to characterize sirolimus plasma levels. During the trial, participants will undergo lesion preparation and treatment with either the DEB or DES. Follow-up assessments include evaluation of target lesion failure, defined as cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization at 12 months. The pharmacokinetic substudy involves blood sample collection for up to 6 months. Overall, the study involves monitoring safety and effectiveness outcomes, with participant follow-up extending to at least 12 months post-procedure.

SELUTION 4 De Novo Small Vessel IDE Trial