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Bleeding Risk",[13],"Device: Percutaneous Coronary Intervention with DCB and DAPT",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Percutaneous Coronary Intervention with DCB and DAPT","* Patients with PCI (DCB) + standard DAPT standard dual antiplatelet therapy (DAPT)\n* Patients with PCI (DCB) + short DAPT",[9],[21,27],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"IGNACIO J AMAT SANTOS, MD, PhD","CONTACT","34983420000","86571","ijamat@gmail.com",{"name":28,"role":23,"phone":29,"phoneExt":10,"email":30},"FUNDACION EPIC","0034987876135","iepic@fundacionepic.org",[32,45,54,64,72,83,92,101,110,119,128,137,146,155,164,173,181,190,199],{"facility":33,"status":34,"city":35,"state":10,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":10},"Clinica 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Valladolid","Valladolid","47003",{"type":40,"coordinates":204},[205,206],-4.72353,41.65541,{"lat":206,"lon":205},{"type":209,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100540816","prevail-paclitaxel-coated-balloon-in-small-coronary-disease-and-high-bleeding-risk-patients-100540816",false,"NCT06321757","PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients","PARIS","Inclusion Criteria:\n\nPatients with:\n\n* PCI with DCB on native arteries with diameters \\\u003C 3 mm.\n* Indication for PCI in acute coronary syndrome or chronic coronary syndrome or silent angina with an indication for PCI.\n\nsyndrome or silent angina with an indication for PCI.\n\n* If previous lesion preparation was required after which angiographic residual lesion should not exist with diameter stenosis \\> 30% or flow-limiting coronary dissections.\n* All antithrombotic therapies administered prior to the procedure are accepted. Still, they can be changed after the procedure.\n* Capacity to understand and sign the written informed consent.\n* 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.\n\nExclusion Criteria:\n\nPatients with:\n\n* Concomitant lesions on vessels \\> 3 mm in diameter in the same coronary territory.\n* PCI on in-stent restenoses.\n* PCI on culprit lesions of acute coronary syndrome with ST segment elevation.\n* 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.\n* Life expectancy \\\u003C12 months\n* Pregnancy.\n* Participation in clinicaltrials.\n* Inability to give the written informed consent.\n* Specific exclusion criteria for the high-bleeding risk patient subgroup:\n* Past medical history of stent thrombosis.\n* Indication for dual antiplatelet therapy for a different reason.","ALL","18 Years",{"count":220,"type":221},501,"ESTIMATED","5 Years","OBSERVATIONAL","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.",[226],"Coronary Artery Disease",[228,229,230,231],"drug-coated balloon","paclitaxel","small native vessel coronary artery disease","coronary stenoses","2026-06-23",{"date":234,"type":235},"2026-06-24","ACTUAL",{"date":237,"type":235},"2024-02-26",{"date":239,"type":221},"2026-12-30",{"name":5,"class":6},19]