[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"de-novo-coronary-lesions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:de-novo-coronary-lesions":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100616271","randomised-trial-of-dual-device-treatment-involving-drug-coated-balloon-angioplasty-and-drug-eluting-stent-implantation-compared-to-single-device-treatments-in-patients-with-diabetes-mellitus-100616271",false,"NCT07303439","Randomised Trial of Dual Device Treatment Involving Drug-coated Balloon Angioplasty and Drug-eluting Stent Implantation Compared to Single Device Treatments in Patients With Diabetes Mellitus","DUBSTENT-DM","Inclusion Criteria:\n\n1. Patients with acute or chronic coronary syndrome\n2. Diagnosis of diabetes\n3. Patients undergoing PCI for de novo lesions in native coronary arteries\n4. Patients able and willing to provide written informed consent\n5. Age ≥ 18 years.\n6. Patients able and willing to comply with the study procedures and follow-up.\n7. All angiographic inclusion criteria fulfilled:\n\n   1. the lesion has been deemed treatable\n   2. the guidewire has crossed the lesion\n   3. the lesion has been successfully pre-dilated, where balloon expansion is complete, residual stenosis is less than 50% and thrombolysis in myocardial infarction (TIMI) flow is \\>2, and there is no evidence of flow-limiting dissection is seen.\n\nExclusion Criteria:\n\n1. Lesions located at the left main coronary artery.\n2. Patient presents with a ST-elevation myocardial infarction (STEMI).\n3. Patient with acute cardiac decompensation or acute cardiogenic shock.\n4. Patient with impaired renal function (glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m2).\n5. Severe in-stent calcification that prevents a sufficient expansion of the DCB, unless adequately pre-treated, e.g. with super (high) pressure balloon, rotablation or lithotripsy.\n6. Evidence of high-grade dissection (National Heart, Lung, and Blood Institute (NHLBI) class C or greater) at baseline\n7. Known hypersensitivity or contraindication to sirolimus, paclitaxel, heparin, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.\n8. Patients unable to take dual antiplatelet therapy for 6-12 months\n9. Pregnant and\u002For breast-feeding females or females who intend to become pregnant during the time of the study.\n10. Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.\n11. Anticipated difficulties to complete the angiographic surveillance.\n12. Patient with a life expectancy of less than 12 months.\n13. Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.\n14. The study will not recruit participants who, in the opinion of the investigator, do not have an adequate understanding of English. Only participants who can fully comprehend the implications of participating in the study will be recruited","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"NA","Purpose of this study:\n\nThe purpose of the study is to find out whether using a drug coated balloon in combination with a drug-eluting stent is better than the standard practice of using either device on its own. This study is specifically looking at patients with diabetes who have coronary artery disease. This means that their arteries become restricted or blocked, and these restrictions or blockages are called lesions. The study will look at diabetic patients undergoing treatment for lesions in segments of their coronary arteries that have not previously been treated with stents. These are called 'de novo' lesions.\n\nThe treatment being investigated:\n\nIn this study, we are comparing two devices, either used together or on their own to treat coronary artery disease. These devices are commercially available in Europe and carry the mark. This study is being carried out to compare the effectiveness of combining the two devices or using them individually:\n\n* Pantera® Lux® Paclitaxel Drug Coated Balloon, abbreviated Pantera® Lux® (DCB) A drug coated balloon is a balloon which is covered by an anti-proliferative drug.\n* Orsiro® biodegradable polymer Sirolimus Eluting Stent Orsiro® (DES) A stent is a short, wire mesh tube that acts like a scaffold to keep your artery open. A drug eluting stent is coated with medication that reduces the risk of the artery becoming blocked again.\n\nBoth drug-eluting stents and drug-coated balloons are used routinely for the treatment of 'de novo' coronary artery disease in Europe.\n\nHow will the study be carried out?\n\nThis study is being conducted in 4 hospitals across Ireland. We aim to recruit 120 participants s in this study. If you agree to participate in this study and sign the informed consent form, you will be asked to participate in the screening process, which will determine if you meet the conditions to participate in the study.\n\nYou will be \"randomised\" into one of the 3 study groups. Randomisation means that you are put into a group by chance (similarly to the roll of a dice). Neither you nor your doctor can choose the group you will be in. You will not know which group you were placed in until the end of the study. However, your doctor will know which study group you were placed in.\n\n* 40 patients will be treated with Pantera® Lux® (Drug Coated Balloon) only\n* 40 patients will be treated with Orsiro® (Drug Eluting Stent) only\n* 40 patients will be treated with a combination of both Pantera® Lux® (Drug Coated Balloon) and Orsiro® (Drug Eluting Stent).\n\nIf you agree to participate in the study you will be invited to come back for a check-up angiogram 6 months after your procedure to make sure that the treatment has been a success. This is sometimes done in normal clinical practice, but it is not done routinely. You will not be charged for this additional test.",[26,27,28,29],"Diabetes Mellitus","Coronary Arterial Disease (CAD)","de Novo Coronary Lesions","De Novo Stenosis",[26,31,32,33,34],"Coronary Artery Disease","Drug-coated Balloon","Drug-Eluting Stent","Target Vessel Failure","RECRUITING","2025-12-10",{"date":38,"type":39},"2025-12-24","ACTUAL",{"date":41,"type":39},"2025-08-06",{"date":43,"type":20},"2031-08-05",{"name":45,"class":46},"Royal College of Surgeons, Ireland","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100605459","the-safety-and-efficacy-of-new-generation-brs-vs-dcb-for-de-novo-large-coronary-artery-lesions-a-prospective-rct-100605459","NCT07162792","The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT","The Safety and Efficacy of New-Generation Bioabsorbable Scaffolds Versus Drug-Coated Balloons in the Treatment of De Novo Lesions in Large Coronary Arteries: A Prospective Randomized Controlled Study","Inclusion Criteria:\n\n* \\- Radiography inclusion criteria\n\n  1. angiographically confirmed de novo coronary artery lesion;\n  2. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);\n  3. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment);\n  4. either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels;\n  5. successful target lesion preparation: residual stenosis ≤30%, no flow-restricting entrapment, and TIMI grade 3 flow; General inclusion criteria\n\n  \u003C!-- -->\n\n  1. subjects at the age between ≥18 and ≤80 years old;\n  2. patients with symptoms or evidence of myocardial ischaemia;\n  3. subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation.\n\nExclusion Criteria:\n\n* 1\\. in-stent lesions; 2. For the left main disease, chronic total occlusive lesions; 3. bifurcation lesion (reference vessel diameter of side branch vessels \\> 2.0 mm); 4. Severely calcified lesions and tortuous lesions; lesions that have failed pretreatment; lesions unsuitable for balloon delivery and dilatation; 5. Previous use of any brand of drug-coated balloon in the target vessel. General inclusion criteria\n\n  1. Any patient with myocardial infarction within one month;\n  2. Patients with severe congestive heart failure (NYHA Level III severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 40%;\n  3. Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;\n  4. Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;\n  5. Patients with severe renal failure(eGFR\\\u003C30ml\u002Fminute) or such medical history, failure to comply with angiography conditions;\n  6. Subjects who are intolerance or allergic to heparin, contrast agent, polyethylene oxide and polylactic acid - glycolic acid polymer;\n  7. Patients who plans to accept selective operation within 1 year;\n  8. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;\n  9. Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.","80 Years",{"count":57,"type":20},150,[23],"This study plans to enroll 150 patients who are candidates for \"intervention without implantation\" therapy and they will be randomly assigned in a 1:1 ratio to either the new-generation Firesorb scaffold group (BRS group, N=75) or the drug-coated balloon group (DCB group, N=75). All enrolled patients will undergo angiographic follow-up at 1 year post-procedure, and serial follow-up (via telephone or outpatient visit) will be performed at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure. The primary study endpoint was percentage diameter stenosis at 1 year post-procedure.",[61,28],"Coronary Artery Disease(CAD)",[63,64,65],"drug-coated balloon","percutaneous coronary intervention","bioresorbable scaffold","NOT_YET_RECRUITING","2025-09-01",{"date":69,"type":39},"2025-09-09",{"date":71,"type":20},"2025-10-23",{"date":73,"type":20},"2028-12-30",{"name":75,"class":46},"Xuzhou Third People's Hospital"]