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.
Life expectancy >1 year in the Investigator's opinion.
Participant is willing and able to cooperate with study procedures and follow-up evaluations.
Participant is pregnant, or breastfeeding. Note: Participant of childbearing potential must have a negative pregnancy test within 7 days before procedure.
Known hypersensitivity or contraindication to antiplatelet medications (e.g., aspirin; heparin; prasugrel); or a sensitivity to contrast media which cannot be adequately pre-medicated.
History of an allergic reaction or significant sensitivity to paclitaxel, sirolimus, or any other analogue or derivative.
Platelet count < 100,000 cells/mm³ (i.e., 100 x 109 /L) or > 700,000 cells/mm³ (i.e., 700 x 10 9 /L), or a white blood cell (WBC) count < 3,000 cells/mm³ within 7 days prior to procedure.
Single group
SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter
DeviceSirPlux Duo PTCA is a Drug-Coated Balloon to treat de novo and In-Stent Restenosis lesions in patients with symptomatic stable angina, unstable angina or NSTEMI
Target lesion failure rate (TLF)
Target lesion failure rate (TLF) at 12 months post-procedure
Performance - Device Sucess
Device Success: Defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device.
Performance - Lesion Success
Defined as achievement of ≤30% residual stenosis (by visual estimate) of the target lesion upon SirPlux Duo PTCA treatment
Performance - Procedural Success
Defined as device and lesion success, and absence of procedural complications following study device inflation (i.e., absence of significant vessel dissection \[Grade C or higher\] or loss of TIMI 3 flow) through 7 days post-procedure
Late Lumen Loss
Late Lumen Loss based on QCA
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