Study of SirPlux Duo Dual API-Coated Balloon Catheter to Treat Coronary In-Stent Restenosis and Small New Coronary Lesions in Patients With Symptomatic Coronary Artery Disease

What this Trial Is About

Researchers are evaluating the SirPlux Duo PTCA, a dual API-coated balloon catheter device, to treat coronary artery disease in patients with symptomatic stable angina, unstable angina, or non-ST elevation myocardial infarction NSTEMI. The study focuses on treating two types of coronary lesions in-stent restenosis ISR lesions measuring 2.00 to 4.00 mm in diameter and de novo lesions smaller than 3.00 mm. The goal is to assess the safety and performance of this device for these specific coronary conditions. Participants who meet the study criteria will undergo a planned percutaneous coronary intervention PCI using the SirPlux Duo PTCA balloon catheter. Only one target lesion will be treated per participant, with specific size and stenosis requirements for the target lesion. The treatment involves delivering the drug-coated balloon to the affected coronary vessel to evaluate procedural success and device performance. During the study, participants will be closely monitored with follow-up visits to assess outcomes such as target lesion failure rate at 12 months, procedural success, lesion success, late lumen loss at 6 months, and safety measures up to 24 months after the procedure. The study will involve various evaluations, including functional tests and clinical assessments, to track the devices performance and participant health throughout the follow-up period.

Advanced NanoTherapies Dual-API DCB to Treat De-Novo and ISR Lesions in Patients With Symptomatic Coronary Artery Disease