[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-coated-balloon\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-coated-balloon":192},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,82,115,146,172],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100622588","a-single-arm-trial-to-evaluate-the-safety-and-efficacy-of-the-long--150mm-passeotm-18-luxtm-drug-coated-balloon-in-the-treatment-of-subjects-with-infrainguinal-stenotic-restenotic-or-occlusive-lesions-100622588",false,"NCT07385573","A Single Arm Trial to Evaluate the Safety and Efficacy of the Long (> 150mm) PasseoTM-18 LuxTM Drug-coated Balloon in the Treatment of Subjects With Infrainguinal Stenotic, Restenotic or Occlusive Lesions","LUX-PAD","Inclusion Criteria\n\n* Study participant is ≥ 18 years and ≤ 99 years old\n* Lesion(s) in the infrainguinal arteries:\n\n  * Lesion above the knee (ATK): Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)\n  * Lesion below the knee (BTK): Target lesions involve arteries below the tibial plateau\n* RVD 2-7mm\n* De novo stenotic, restenotic post POBA, or occlusive lesion(s)\n* Target lesion must have angiographic evidence of ≥70% stenosis\n* Lesion length ≥ 3cm\n* Successful crossing of the target lesion with the guide wire\n* Successful predilatation, defined as residual stenosis \\\u003C50% Rutherford Class 2-5\n* Study participant is able to provide consent and has signed and dated the informed consent form\n\nExclusion criteria\n\n* Life expectancy ≤ 1 year\n* Study participant is currently participating in another investigational drug or device study that has not reached its primary endpoint yet.\n* Study participant is pregnant, planning to become pregnant, or father children during the course of the study.\n* Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion).\n* Prior bypass surgery of target vessel\n* Planned major amputation of the target limb\n* Thrombus in the target vessel\n* Known allergy to contrast media that cannot be adequately controlled with premedication\n* Study participant has a single target lesion that involves both ATK and BTK segments","ALL","18 Years","99 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","This clinical trial will evaluate the study device, Passeo®-18 Lux® paclitaxel-releasing percutaneous transluminal angioplasty (PTA) balloon catheter for the treatment of new or recurring cholesterol-related blockages in the arteries of the lower leg.\n\nThe device that is used in this trial has been assessed in several previous studies for safety and effectiveness. The device is already approved for use in Europe. It has a \"CE mark,\" which means it meets the European Union's safety, health and performance standards.\n\nThis trial is being done to gather additional information on how well the device works and how safe it is when used in everyday medical care with specific attention to the longer lengths of the balloon, as it comes in different sizes.",[27,28],"Drug Coated Balloon","Peripheral Arterial Disease",[14,30,31],"Passeo-18 Lux Long","Passeo-18","NOT_YET_RECRUITING","2026-06-08",{"date":35,"type":36},"2026-06-09","ACTUAL",{"date":38,"type":21},"2026-06",{"date":40,"type":21},"2032-01",{"name":42,"class":43},"KANDO Research","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100595896","leave-nothing-behind-study-which-compares-dcb-with-bail-out-brs-versus-brs-strategy-alone-100595896","NCT07038408","Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone","Multi-center, Open-label, Prospective, Randomized Study to Show Long-term Efficacy of DCB Treatment With Bail-out BRS in Comparison to BRS Treatment of De-novo Native Coronary Artery Lesions in a Relatively Young PCI Population.","LNB","Inclusion Criteria:\n\n* Patients aged ≥ 18 years ≤ 68 years\n* Single vessel or multivessel disease with low to moderate complex de-novo native coronary artery lesions up to 30 mm length and reference vessel diameter 2.75-4.0 mm\n* Maximum of 3 target lesions\n* Maximal cumulative lesion length of all treated lesions 80 mm\n* Signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* ST-segment Elevation Myocardial Infarction (STEMI) treatment at index or in the previous 48 hours\n* Severe calcified lesions\n* Bifurcations lesions with planned 2 device strategy\n* Left-Main (LM) disease ≥ 50% diameter stenosis\n* More than 3 target lesions\n* Renal insufficiency with Glomerular Filtration Rate (GFR) \\\u003C 45 ml\u002Fmin\n* Life expectancy less than 1 year\n* Known hypersensitivity or allergy to aspirin or P2Y12 receptor inhibitors\n* Incapable of providing written informed consent\n* Pregnant or breastfeeding women\n* Under judicial protection, tutorship, or curatorship\n* Participation in another trial","68 Years",{"count":54,"type":21},2256,[24],"The goal of this study is to investigate the equivalence in early and long-term efficacy between the two \"Leave nothing behind strategies\" (Drug-Coated Baloon \\[DCB\\] strategy with bail-out BioResorbable Scaffold \\[BRS\\] versus BRS strategy) of de-novo native coronary artery lesions in a relatively young Percutaneous Coronary Intervention (PCI) population, to be more specific, Patients with Chronic Coronary Syndromes (CCS) and Acute Coronary Syndrome (ACS) (Non-ST-segment Elevation Myocardial Infarction \\[NSTEMI\\] and Unstable angina) between 18-68 years of age scheduled for PCI. The main questions aim to answer are:\n\nDCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 12 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has noninferior angiographic in-segment net gain at 13 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 60 months compared to BRS strategy?\n\nParticipants will be followed at:\n\n1. st FU visit - 1 month (in hospital)\n2. nd FU visit - 6 months (telephone)\n3. rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint\n4. th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy\n5. th FU visit - 730 days±30 days (telephone call) - 2Y\n6. th FU visit - 1095 days±30 days (telephone call) - 3Y\n7. th FU visit - 1460 days±30 days (telephone call) - 4Y\n8. th FU visit- 1825 days±30 days (telephone call) - 5Y",[27,58,59,60],"Bioresorbable Scaffold","Percutaneous Coronary Intervention (PCI)","Acute Coronary Syndrome (ACS)",[62,63,64,65,66,67,68,69],"MULTI-CENTER","OPEN-LABEL","PROSPECTIVE","RANDOMIZED STUDY","LONG-TERM EFFICACY OF DCB TREATMENT WITH BAIL-OUT BRS","BRS TREATMENT","DE-NOVO NATIVE CORONARY ARTERY LESIONS","YOUNG PCI POPULATION","RECRUITING","2026-04-27",{"date":73,"type":36},"2026-04-30",{"date":75,"type":36},"2026-04-24",{"date":77,"type":21},"2032-03",{"name":79,"class":80},"Ceric Sàrl","INDUSTRY",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":100,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":81},"100627155","safety-and-effectiveness-of-the-crystalline-sirolimus-eluting-device-in-patients-with-coronary-artery-disease-100627155","NCT07444957","Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease","Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device (SeQuent® Sirolimus-Coated Balloon) in Patients With Coronary Artery Disease: A Prospective Observational Study","SECuRE","Inclusion Criteria:\n\n* All patients must provide written informed consent.\n* Patients aged ≥18 years with coronary artery disease in whom, at the operator's discretion, treatment of a coronary stenosis in a native vessel (either de novo lesion or in-stent restenosis) or in a coronary bypass graft using the cSCB is indicated, in accordance with routine clinical practice.\n* All treated lesions\u002Fsegments (single or tandem) must receive cSCB therapy covering at least 3 mm beyond both edges of the lesion or pre-dilated segment to avoid geographic miss.\n* In patients with multivessel coronary artery disease, all non-target vessels will be treated according to operator discretion: a) If more than one vessel is treated with the investigational device (SeQuent® SCB), all vessels will be documented and analyzed separately. b) Only one lesion per vessel will be included unless lesions are separated by ≥20 mm. c) Only one lesion per vessel will be included. d) If more than one lesion in the target vessel requires treatment, all lesions treated with a device different from the investigational procedure or with a device other than the investigational device (SeQuent® SCB) must be separated from the target lesion by ≥20 mm or considered as a single treated lesion according to this study protocol.\n\nExclusion Criteria:\n\n* Explicit refusal by the patient to participate in the study.\n* Known intolerance to sirolimus or to any component of the investigational device.\n* Contraindication to any antiplatelet therapy.\n* Life expectancy less than 12 months.\n* Indication for surgical coronary revascularization.\n* Pregnancy or breastfeeding.\n* Clinical characteristics considered unsuitable for drug-coated balloon use at the operator's discretion, including: a) Hemorrhagic diathesis or other conditions such as gastrointestinal ulceration or cerebrovascular disorders restricting the use of antiplatelet therapy. b) Cardiogenic shock. c) Patients with left ventricular ejection fraction \\\u003C30% without the use of a ventricular assist device during PCI.\n\nAngiographic exclusion criteria\n\n* Reference vessel diameter \\\u003C2.00 mm or \\>4.0 mm.\n* Treatment of the left main coronary artery.\n* Lesions not amenable to PCI or other interventional techniques.\n* Coronary artery spasm in the absence of significant stenosis.\n* Target lesion not suitable for drug-coated balloon-only PCI at the operator's discretion, including: a) Aorto-ostial lesions. b) Lesions with significant persistent residual thrombotic content visible in the vessel despite thromboaspiration. c) Treatment shortly after myocardial infarction with evidence of thrombus or impaired coronary flow.",{"count":91,"type":21},1118,"OBSERVATIONAL","This prospective, multicenter, post-market observational study aims to evaluate the safety and effectiveness of the crystalline sirolimus-coated balloon (SeQuent® Sirolimus-Coated Balloon) for the treatment of coronary artery disease in routine clinical practice. Consecutive, unselected adult patients undergoing percutaneous coronary intervention for de novo coronary lesions or in-stent restenosis will be enrolled.\n\nThe primary objective is to assess target lesion failure at 12 months, defined as the composite of target vessel myocardial infarction or ischemia-driven target lesion revascularization. Secondary objectives include angiographic procedural success, major adverse cardiovascular events, bleeding outcomes, and longer-term clinical results up to 36 months, as well as outcomes across predefined anatomical and clinical subgroups.\n\nThe study seeks to answer whether treatment with the crystalline sirolimus-coated balloon provides a safe and effective revascularization strategy in a real-world population with diverse clinical presentations and lesion characteristics.",[95,96,97,27,98,99],"Coronary Arterial Disease (CAD)","NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)","Stable Angina, Unstable Angina, NSTEMI","ST-Elevation Myocardial Infarction","Silent Ischemia",[101,102,103,104,105],"coronary arterial disease","drug coated ballloon","TLR","TVR","MACE","2026-03-02",{"date":108,"type":36},"2026-03-03",{"date":110,"type":36},"2026-01-05",{"date":112,"type":21},"2030-07-06",{"name":114,"class":43},"Fundación Interhospitalaria para la Investigación Cardiovascular FIC",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":130,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"100623543","discontinuation-of-antiplatelet-therapy-after-drug-coated-balloon-treatment-100623543","NCT07398001","Discontinuation of Antiplatelet Therapy After Drug-Coated Balloon Treatment","Inclusion Criteria:\n\n1. Adults aged 19 years or older who are able to understand the risks, benefits, and treatment alternatives of the study and who provide written informed consent voluntarily.\n2. Patients who underwent drug-coated balloon treatment at least 12 months prior to enrollment.\n3. Patients who have not experienced major adverse cardiovascular events, including myocardial infarction, stroke, or target vessel revascularization, since the index DCB treatment.\n4. Patients who have not experienced major bleeding since the index DCB treatment.\n5. Patients who are receiving antiplatelet therapy at the time of enrollment.\n\nExclusion Criteria:\n\n1. Patients with concomitant vascular disease requiring long-term antiplatelet therapy.\n2. Patients with non-cardiac comorbid conditions that, in the judgment of the investigator, are associated with a life expectancy of less than 1 year or may result in poor compliance with the study protocol.\n3. Patients who are participating in another drug or coronary device clinical study at the time of enrollment.","19 Years",{"count":123,"type":21},1042,[24],"The goal of this clinical trial is to evaluate the benefits and risks of discontinuing antiplatelet therapy on clinical outcomes in patients who previously underwent coronary intervention using a drug-coated balloon.\n\nThe main questions it aims to answer are:\n\nDoes stopping antiplatelet therapy after 12 months affect the risk of net adverse clinical events? Does stopping antiplatelet therapy reduce the risk of bleeding compared with continuing treatment?\n\nResearchers will compare patients who discontinue antiplatelet therapy with patients who continue antiplatelet therapy to determine the impact on clinical outcomes during follow-up.\n\nParticipants will:\n\nBe randomly assigned to either discontinue or continue antiplatelet therapy Receive routine clinical follow-up through clinic visits or telephone contacts Be monitored for cardiovascular events and bleeding outcomes over time",[127,128,129],"Percutaneous Coronary Intervention","Antiplatelet Therapy","Drug-coated Balloon",[131,132,133,134,135],"coronary artery disease","drug-coated balloon","percutaneous coronary intervention","antiplatelet therapy","clinical outcomes","2026-02-02",{"date":138,"type":36},"2026-02-09",{"date":140,"type":21},"2026-02-12",{"date":142,"type":21},"2030-07-31",{"name":144,"class":43},"Ulsan University Hospital",7,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":156,"studyType":92,"phases":4,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":81},"100610765","registry-of-coronary-disease-outcomes-revascularizing-with-drug-coated-balloons-100610765","NCT07231835","Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons","RECORD-DCB: Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons","RECORD-DCB","Inclusion Criteria:\n\n* Patients undergoing PCI with the Protégé paclitaxel-eluting DCB\n* Age ≥ 18 years\n* Presence of a de novo lesion or in-stent restenosis in a native coronary artery or a in a bypass graft and suitable for PCI\n* Reference vessel diameter between 2.0 - 4.5 mm\n* Patient suitable for dual antiplatelet therapy (DAPT)\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Allergy to paclitaxel",{"count":155,"type":21},3000,"5 Years","The primary aim of this registry is to systematically collect and analyze real-world data on all patients undergoing PCI with the Protégé paclitaxel-eluting DCB to evaluate procedural outcomes, long-term efficacy, and safety across various clinical indications. This registry aims to assess the clinical effectiveness of DCB therapy across diverse patient populations, including those with stable coronary artery disease (CAD) and acute coronary syndromes (ACS), as well as various lesion subsets, encompassing (but not limited to) in-stent restenosis (ISR), de novo coronary lesions, small vessel disease, bifurcation and calcified lesions, coronary bypass graft lesions, and patients at high risk of bleeding. Additionally, the study aims to identify predictors of success, complications, and optimal treatment strategies to further refine the use of DCBs.",[59,27,159,160,161,162],"Paclitaxel","CAD - Coronary Artery Disease","ACS (Acute Coronary Syndrome)","Stable Coronary Artery Disease (CAD), Myocardial Infarction","2025-11-14",{"date":165,"type":36},"2025-11-17",{"date":167,"type":36},"2025-11-11",{"date":169,"type":21},"2034-09-30",{"name":171,"class":43},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":178,"targetDuration":180,"studyType":92,"phases":4,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":81},"100410037","impact-of-drug-coated-balloon-treatment-in-de-novo-coronary-lesion-100410037","NCT04619277","Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion","Inclusion Criteria:\n\n\\- de novo coronary artery disease\n\nExclusion Criteria:\n\n* unstable hemodynamics at presentation\n* life expectancy \\\u003C1 year",{"count":179,"type":21},10000,"1 Year","This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion.",[129],"2024-08-12",{"date":185,"type":36},"2024-08-15",{"date":187,"type":36},"2011-04-22",{"date":189,"type":21},"2030-12-31",{"name":191,"class":43},"Ulsan Medical Center","Drug-coated-balloon"]