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

Exclusion Criteria

• •1. Participant is pregnant, or breastfeeding. Note: Participant of childbearing potential must have a negative pregnancy test within 7 days before procedure.
• •2. Known hypersensitivity or contraindication to antiplatelet medications (e.g., aspirin; heparin; prasugrel); or a sensitivity to contrast media which cannot be adequately pre-medicated.
• •3. History of an allergic reaction or significant sensitivity to paclitaxel, sirolimus, or any other analogue or derivative.
• •4. 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.
• •5. Renal insufficiency (Serum creatinine level \> 2.5 mg/dl (i.e., 221 μmol/L) within 7 days prior to procedure) or failure (dialysis dependent).
• •6. Evidence of an acute MI within 72 hours of the procedure Note: participants with NSTEMI are allowed, provided enzymes are trending down or are within normal limits prior to enrollment.
• •7. Previous PCI of the target vessel within 6 months prior to procedure.
• •8. History of a stroke or transient ischemic attack (TIA) within the prior 3 months to procedure (any prior stroke or TIA, if prasugrel is used).
• •9. Planned PCI of any vessel within 30 days post-procedure and/or planned PCI of the target vessel within 12 months post-procedure.
• •10. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months to procedure.
• •11. History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• •12. Documented left ventricular ejection fraction (LVEF) \<30% at the most recent evaluation, within the prior 3 months to procedure.
• •13. Planned surgery that would cause interruption in recommended DAPT duration per current guidelines.
• •14. Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary angiography, IVUS, or other coronary artery imaging procedures.
• •15. The following criteria related to previous treatments applies based on the type of lesion treated. The participant is excluded in the following circumstances:
• •1. ISR lesions: If single-layer ISR, any previous treatment of the target vessel for restenosis. If double- layer ISR, any treatment of the double-layer ISR.
• •2. de novo lesions: any previous treatment of the target lesion.
• •16. Planned PCI of three vessel disease during procedure.
• •17. Planned treatment of more than one target vessel. Tandem lesions that can be treated by a single DCB are permissible.
• •18. Target lesion requires treatment with atherectomy, laser, or thrombectomy procedure.
• •19. Target vessel has other lesions with greater than 50% diameter stenosis based on visual estimate.
• •20. Target vessel has evidence of thrombus.
• •21. Target vessel is excessively tortuous, defined as more than one bend \>90° to reach target lesion.
• •22. Target lesion has any of following characteristics:
• •1. Lesion location is unprotected in left main coronary artery, internal mammary artery, aorto-ostial, bypass grafts, ostial lesions or within 5 mm of the origin of the left anterior descending or left circumflex.
• •2. Involves a side branch \>2.0 mm in diameter.
• •3. Is severely calcified.
• •23. The following criteria based on number and type of lesions:
• •1. ISR and de novo lesions: target lesion is in the same vessel with a de novo lesion requiring treatment.
• •2. ISR lesions: planned treatment of a ≥3 layer ISR lesion.