prevail paclitaxel-coated balloon in small coronary disease and high-bleeding risk patients

Conditions: Coronary Artery Disease

Summary: 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.

post-market, prospective, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon 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 pci with dcb will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician. the angiographic study will be analyzed in a core lab (icicorelab) blinded to the procedural outcomes and the patients' follow-up. as per clinical practice, 1-year clinical follow-up of all the patients will be conducted with a first assessment at 30 days, a second assessment at 6 months, and one final assessment at 12 months. should the patient have an elevated bleeding risk -defined as concomitant therapy with oral anticoagulation or a precise-dapt score ≥ 25- patients will be included in a high-bleeding risk substudy. the antiplatelet therapy regime will be administered according to the local investigator and the treating medical team.

Eligibility criteria:
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 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. 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 acute coronary syndrome with st segment elevation may be included in the study, if only non-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.

Keywords: drug-coated balloon paclitaxel small native vessel coronary artery disease coronary stenoses