Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)

Exclusion Criteria14

• Subject has known hypersensitivity or contraindication to any of the study drugs (including all asprin, P2Y12 inhibitors, one or more components of the study devices, including paclitaxel, etc) that cannot be adequately pre-medicated
• Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
• Hypotension, shock, or need for mechanical support or intravenous vasopressors;
• Creatinine clearance ≤30 ml/min/1.73 m\^2 (as calculated by MDRD formula for estimated GFR)
• Left ventricular ejection fraction<30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others)
• Life expectancy <2 years for any
• Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
• The target lesion is located within 10 mm of the proximal or distal of stent
• The target lesion cannot be in the left main coronary artery
• The target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is >2 mm with >50% of stenosis)
• The target lesion is located in severe calcification or tortuosity of vessels
• The target lesion involved in the ostium of LAD, LCX or RCA (within 3 mm of the ostium)
• The target lesion is located within the bypass graft artery