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

Inclusion Criteria:

Patients with:

• PCI with DCB on native arteries with diameters < 3 mm.

• Indication for PCI in acute coronary syndrome or chronic coronary syndrome or silentangina with an indication for PCI.

syndrome or silent angina with an indication for PCI.

• If previous lesion preparation was required after which angiographic residual lesionshould 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.

Exclusion Criteria:

Patients with:

• Concomitant lesions on vessels > 3 mm in diameter in the same coronary territory.

• PCI on in-stent restenoses.

• PCI on culprit lesions of acute coronary syndrome with ST segment elevation.

• Patients with an indication for PCI on additional non-culprit lesions of acutecoronary syndrome with ST segment elevation may be included in the study, if onlynon-culprit lesions are considered for the study.

• Life expectancy <12 months

• Pregnancy.

• Participation in clinicaltrials.

• Inability to give the written informed consent.

• Specific exclusion criteria for the high-bleeding risk patient subgroup:

• Past medical history of stent thrombosis.

• Indication for dual antiplatelet therapy for a different reason.