The SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter is an investigational medical device to be used to treat de-novo lesions in patients with symptomatic coronary artery disease. In this study, SirPlux Duo™ will be used in subjects undergoing a planned percutaneous coronary intervention. Population to treat will include those with de-novo coronary lesions in vessels with a reference vessel diameter (RVD) of ≥2.25 and ≤4.0 mm and a total lesion length of <35mm with documented symptomatic stable coronary artery disease. The study is a prospective, single-arm, multi-center, safety and feasibility first-in-human study designed to generate descriptive data about the use of SirPlux Duo™. The study primary performance endpoint is device success, technical success and procedural success. The safety primary endpoint (angiographic endpoint) is In-segment Late Lumen Loss (LLL) at 6 months. Other safety secondary clinical and angiographic endpoints (detailed below) will me measured during procedure up to 24 hours after discharge, at 30 days, 6 months, 12 months and 24 months after procedure.
This prospective, single-arm, multi-center, safety and feasibility first-in-human study will evaluate the safety and feasibility of the SirPlux™ Duo Dual-API Coated PTCA Balloon Catheter to treat de-novo lesions between ≥2.25 and ≤4.0 mm in patients with stable symptomatic coronary artery disease.