PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
Post-market, prospective, observational, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon (DCB)therapy in real-world patients with small native vessel coronary artery disease, and to demonstrate the safety of short dual antiplatelet therapy (7 days) in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy. A percutaneous coronary intervention (PCI) with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician.
⁃ Patients with:
• PCI with DCB on native arteries with diameters \< 3 mm.
• Indication for PCI in acute coronary syndrome or chronic coronary syndrome or silent angina with an indication for PCI.
⁃ syndrome or silent angina with an indication for PCI.
• If previous lesion preparation was required after which angiographic residual lesion should not exist with diameter stenosis \> 30% or flow-limiting coronary dissections.
• All antithrombotic therapies administered prior to the procedure are accepted. Still, they can be changed after the procedure.
• Capacity to understand and sign the written informed consent.
• If the patient has a high-bleeding risk defined by 1) PRECISE-DAPT SCORE ≥ 25 or 2) an indication for concomitant oral anticoagulation he can be included in the high- bleeding risk substudy as long as he does not meet the specific exclusion criteria.