[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585222":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":11,"locations":10,"responsibleParty":17,"collaborators":10,"id":21,"slug":22,"hasResults":23,"nctId":24,"briefTitle":25,"officialTitle":26,"acronym":27,"eligibilityCriteria":28,"healthyVolunteers":23,"sex":29,"minAge":30,"maxAge":10,"enrollmentInfo":31,"targetDuration":34,"studyType":35,"phases":10,"briefSummary":36,"conditions":37,"keywords":10,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":10},{"fullName":5,"class":6},"Craigavon Area Hospital","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":10},"Single Arm, 500 Patients",null,[12],{"name":13,"role":14,"phone":15,"phoneExt":10,"email":16},"Dr Ian Brian Alexander Menown, MD(QUB), MB BCh BAO(QUB), MRCP","CONTACT","+ 44 2838 334444","ian.menown@southerntrust.hscni.net",{"type":18,"investigatorFullName":19,"investigatorTitle":20,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Dr I. B. A. Menown","Director, Interventional Research, Craigavon","100585222","registry-of-paclitaxel-coated-drug-eluting-balloon-in-all-comers-patients-100585222",false,"NCT06899555","REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients","REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients (REPEAT Registry)","REPEAT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients with symptomatic coronary artery disease (including those with acute coronary syndromes or Chronic Coronary Syndromes) with either symptoms and\u002For ischaemia.\n* The patient must be able to understand and provide informed consent and comply with all study procedures.\n\nCoronary angiographic inclusion criteria:\n\n* ≥70% target lesion stenosis in LAD, LCX or RCA (or branches) which after successful pre-dilatation\\* has a residual stenosis ≤ 30% and no dissection of Type C or greater than (NHLBI guidelines)\n\n  \\*pre-dilation permitted with SC or NC balloon catheter, cutting\u002Fscoring balloon, rotational\u002Forbital atherectomy, or laser\n* Target vessel reference diameter between 2.0 and 4.5 mm.\n\nExclusion Criteria:\n\n* Left ventricular ejection fraction (LVEF) ≤ 30%\n* Acute ST elevation MI (STEMI)\n* Cardiogenic shock within 2 days prior to the index PCI.\n* Known contraindication or hypersensitivity to paclitaxel, and\u002For to any anti-thrombotic and anti-platelet class of drugs\n* Allergy to imaging contrast media which cannot be adequately pre-medicated.\n* Patient undergoing planned surgery within 3 months with the necessity to stop dual antiplatelet therapy (DAPT).\n* Patient is pregnant or breast feeding.\n* Patient has received a heart transplant.\n* Patient is unwilling or unable to give follow-up until study completion.\n* Patient is currently participating in another trial.\n* Life expectancy \\\u003C1 year.\n\nAngiographic exclusion criteria:\n\n* Target lesion in the left main coronary artery.\n* Flow limiting target vessel thrombus\n* Vessel dissection requiring bailout stenting.","ALL","18 Years",{"count":32,"type":33},500,"ESTIMATED","1 Year","OBSERVATIONAL","A post marketing, observational , multi centre, prospective registry to assess safety and performance of the Drug Eluting Balloon in patients undergoing percutaneous coronary intervention.\n\nRational : Although DEBs are generally considered safe, there remain many unanswered questions about DEB technology in a real-world population and only limited trial data from geographically or clinically diverse patient subgroups. To address some of the clinical and translational gaps in knowledge we thus plan a clinical registry to assess safety and performance of a novel design of a drug eluting\n\nA real-world, all-comers coronary artery disease (CAD) population undergoing percutaneous coronary intervention (PCI) and suitable for treatment with a Paclitaxel Coated Coronary Balloon Dilatation Catheter.\n\nStudy Population - 500 Patients",[38],"CAD - Coronary Artery Disease","NOT_YET_RECRUITING","2025-03-21",{"date":42,"type":43},"2025-03-28","ACTUAL",{"date":45,"type":33},"2025-05",{"date":47,"type":33},"2027-05",{"name":5,"class":6}]