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

Prior treatment

• Participant is pregnant, or breastfeeding. Note: Participant of childbearing potential must have a negative pregnancy test within 7 days before procedure.
• 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.
• Previous PCI of the target vessel within 6 months prior to procedure.
• 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).
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months to procedure.
• Planned surgery that would cause interruption in recommended DAPT duration per current guidelines.
• 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.
• The following criteria related to previous treatments applies based on the type of lesion treated. The participant is excluded in the following circumstances:
  • 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.
  • de novo lesions: any previous treatment of the target lesion.
• Target lesion requires treatment with atherectomy, laser, or thrombectomy procedure.

Other illness

• 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.
• History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Planned PCI of three vessel disease during procedure.

Lab values

• 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.
• Renal insufficiency (Serum creatinine level \> 2.5 mg/dl (i.e., 221 μmol/L) within 7 days prior to procedure) or failure (dialysis dependent).
• Documented left ventricular ejection fraction (LVEF) \<30% at the most recent evaluation, within the prior 3 months to procedure.

Other

• Planned PCI of any vessel within 30 days post-procedure and/or planned PCI of the target vessel within 12 months post-procedure.
• Planned treatment of more than one target vessel. Tandem lesions that can be treated by a single DCB are permissible.
• Target vessel has other lesions with greater than 50% diameter stenosis based on visual estimate.
• Target vessel has evidence of thrombus.
• Target vessel is excessively tortuous, defined as more than one bend \>90° to reach target lesion.
• Target lesion has any of following characteristics:
  • 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.
  • Involves a side branch \>2.0 mm in diameter.
  • Is severely calcified.
• The following criteria based on number and type of lesions:
  • ISR and de novo lesions: target lesion is in the same vessel with a de novo lesion requiring treatment.
  • ISR lesions: planned treatment of a ≥3 layer ISR lesion.

• ≥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.