ADVANCEd NanoTherapies SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter to Treat Coronary In-stent Restenosis (ISR) and de Novo Lesions
The study objectives are: 1. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary ISR lesions 2.00-4.00 mm (inclusive) in diameter in patients with symptomatic coronary artery disease. 2. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary de novo lesions \<3.00 mm in diameter in patients with symptomatic coronary artery disease.
• ≥18 years or minimum legal age as required by local regulations.
• Documented stable or unstable angina, positive functional test, or non -ST elevation myocardial infarction which, in the judgment of the operator, is attributable to disease in coronary vessel or in-stent restenosis, and the patient is deemed an appropriate candidate for PCI in accordance with the applicable guidelines on percutaneous coronary intervention.
• Note: participants with NSTEMI must have enzymes that are trending down or are within normal limits prior to enrollment.
• Life expectancy \>1 year in the Investigator's opinion.
• Participant is willing and able to cooperate with study procedures and follow-up evaluations.
• Treatment of only one target lesion required
‣ Tandem lesions treated by a single DCB will be considered one target lesion.
⁃ Up to one de novo lesion in a separate vessel may be treated per standard of care at the procedure. Non-target lesions must be successfully treated under the same criteria of the target lesion, before treating the target lesion.
• Target lesion must be ≤36 mm in length.
• Target lesion must have a stenosis ≥ 50% and \< 100%.
• Target lesion must have a visually estimated reference vessel diameter of:
‣ ISR lesions: 2.0 to 4.0 mm in diameter (inclusive)
⁃ de novo lesions: 2.0 to \<3.0 mm in diameter
• ISR lesions only: target lesion must be within a previous BMS or DES that does not extend \>5.0 mm beyond the proximal or distal edge.