Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment

Exclusion Criteria

• •1. Target lesion has undergone more than two prior stent implant procedures, i.e., more than two layers of stent are present at any segment of target lesion
• •2. Presents with ST-elevation myocardial infarction (STEMI)
• •3. STEMI within the past 72 hours
• •4. Chronic kidney disease, defined as glomerular filtration rate (GFR) \<15 ml/min/1.73m\^2 on baseline labs
• •5. Thrombocytopenia, defined as a platelet count of \<50,000 microL on baseline labs
• •6. Target lesion is a chronic total occlusion
• •7. Bleeding diathesis, coagulopathy, or contraindication to antiplatelet therapy
• •8. Target lesion restenosis is within a bio-resorbable scaffold
• •9. Target lesion is located within the left main
• •10. Pregnant (verified with a urine or blood pregnancy test), breast-feeding, or planning to become pregnant
• •11. Severely disabled and/or life expectancy appears limited (≤12 months) according to the investigator's opinion
• •12. Known hypersensitivity to paclitaxel and/or resveratrol or any of the product ingredients
• •13. Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
• •Note: Bifurcation lesions are not excluded; however, the main branch should be treated per randomization, and the side branch should be treated provisionally per current standard of care.
• •1. Dissection type C - F
• •2. TIMI \< III
• •3. Residual stenosis \>30%