PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients

Prior treatment

• Concomitant lesions on vessels \> 3 mm in diameter in the same coronary territory.
• Indication for dual antiplatelet therapy for a different reason.

Other illness

• PCI on culprit lesions of acute coronary syndrome with ST segment elevation.
• Patients with an indication for PCI on additional non-culprit lesions of acute coronary syndrome with ST segment elevation may be included in the study, if only non-culprit lesions are considered for the study.
• Specific exclusion criteria for the high-bleeding risk patient subgroup:
• Past medical history of stent thrombosis.

Other

• Patients with:
• PCI on in-stent restenoses.
• Life expectancy \<12 months
• Pregnancy.
• Participation in clinicaltrials.
• Inability to give the written informed consent.

• 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.