[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"de-novo-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:de-novo-stenosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100594679","bioresorbable-sirolimus-eluting-scaold-in-de-novo-coronary-artery-lesions-100594679",false,"NCT07022587","Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions","A Bioresorbable Sirolimus-eluting scaffold Versus a Metallic Sirolimus-eluting Stent for the Treatment of de Novo Coronary Artery Lesions: a Randomized, Open-label, Non-inferiority Trial","REC-CAGEFREE Ⅳ","Inclusion Criteria:\n\nClinical inclusion criteria\n\n1. Patients with an indication for PCI due to acute or chronic coronary syndrome\n2. Patients who understand the study's objectives, voluntarily participate, sign the informed consent form, and are willing to undergo regular follow-up\n\nAngiographic inclusion criteria\n\n1. De novo lesion(s)\n2. Target vessel diameter of ≥ 2.5 mm to ≤ 4.00 mm, target lesion length ≤ 25 mm (visual estimation)\n3. Target lesion is NOT\n\n   1. Severely calcified\n   2. In-stent restenosis\n   3. Diffused lesion requiring stent overlapping or more than one stent\n   4. Located in the left main, aorto-ostial, proximal LAD\u002FLCX\u002FRCA involving vessel ostia (stent coverage required within 3 mm of vessel ostia), surgical graft, myocardial bridge, or chronic total occlusion\n   5. Bifurcation requiring two stents or involving a side branch that is ≥ 2.5 mm in diameter\n   6. Located in the target vessel with severe tortuosity\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years, or \\> 75 years\n2. Patient is a woman who is pregnant or nursing\n3. Patients who have received any stent implantation in the target vessel within one year\n4. Patients required long-term oral anticoagulation\n5. Known non-adherence to antiplatelet therapy or not suitable for long-term antiplatelet therapy due to high bleeding risk\n6. Patients who are allergic to heparin, poly L-lactic acid (PLLA), sirolimus, antiplatelet drugs, or contrast\n7. Currently participating in another trial and not yet at its primary endpoint\n8. Patients whose life expectancy is less than 3 years\n9. Cardiogenic shock","ALL","18 Years","75 Years",{"count":21,"type":22},2000,"ESTIMATED","INTERVENTIONAL",[25],"NA","Bioresorbable scaffold (BRS) was designed aiming to avoid the late adverse events associated with permanent metallic stents by providing temporary support to the vessel wall and promoting vessel remodeling, plaque reduction, and restoring vasomotion after its full absorption. As the first FDA-approved BRS, ABSORB BRS was associated with a significantly higher risk of late scaffold thrombosis compared with everolimus-eluting stent (EES). As a result, the ESC-EAPCI task force recommended that the current ABSORB BRS should not be preferred over conventional DES in clinical practice. To solve this dilemma, improved scaffold technology and optimal implantation techniques are necessary.\n\nThe latest generation Firesorb BRS is a PLLA backbone scaffold system abluminally coated with poly(D, L-lactide) mixed with sirolimus using highly accurate and precise point spraying techniques. Compared to the ABSORB BRS, Firesorb features a thinner stent thickness (100-125 μm) while maintaining sufficient radial support, enabling faster degradation and a shorter duration of presence in the coronary. Additionally, inspired by the design of the Firehawk DES, its unique spot-coating process applies a single-sided coating layer exclusively to the stent's outer surface, enabling targeted drug release. Preclinical trials have demonstrated favorable performance for Firesorb, culminating in its approval by the National Medical Products Administration (NMPA) in 2024.\n\nAgainst these backgrounds, we have designed this trial to investigate whether the Firesorb BRS is non-inferior to the drug-eluting stent in terms of the Device-Oriented Composite Endpoint (DoCE) in patients undergoing percutaneous coronary intervention for de novo lesions.",[28,29],"De Novo Stenosis","Coronary Artery Disease",[31,32,33,34],"bioresorbable vascular scaffold","drug-eluting stent","de novo stenosis","percutaneous coronary intervention","RECRUITING","2026-02-10",{"date":38,"type":39},"2026-02-13","ACTUAL",{"date":41,"type":39},"2025-12-20",{"date":43,"type":22},"2073-12-20",{"name":45,"class":46},"Xijing Hospital","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"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","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",{"count":56,"type":22},120,[25],"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.",[60,61,62,28],"Diabetes Mellitus","Coronary Arterial Disease (CAD)","de Novo Coronary Lesions",[60,29,64,65,66],"Drug-coated Balloon","Drug-Eluting Stent","Target Vessel Failure","2025-12-10",{"date":69,"type":39},"2025-12-24",{"date":71,"type":39},"2025-08-06",{"date":73,"type":22},"2031-08-05",{"name":75,"class":46},"Royal College of Surgeons, Ireland",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":47},"100472917","stabilization-of-atheroma-by-lipid-reducing-effect-of-drug-coated-balloon-stable-dcb-100472917","NCT05438121","STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)","Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients with Multivessel Coronary Artery Disease: a Serial NIRS-IVUS Imaging Study","STABLE-DCB","Inclusion Criteria:\n\n* Patients with significant multivessel coronary artery disease requiring revascularization\n* Any De novo lesions (reference vessel diameter of 2.25mm\\~4.0mm) suitable for DCB angioplasty\n* Lesion suitable for intravascular imagings\n* Written informed consent\n\nExclusion Criteria:\n\n* Hemodynamically unstable or cardiogenic shock\n* Left main stenotic lesion or graft vessel lesion\n* Visible angiographic thrombus, not resolved by balloon angioplasty\n* Pregnancy or breastfeeding\n* Comorbidities with life expectancy \\\u003C 12 months\n* Severe coronary calcification or tortuosity, hindering timely DCB delivery","85 Years",{"count":86,"type":22},65,"OBSERVATIONAL","This study aims to investigate whether DCB angioplasty, compared to statin-based medical treatment alone, will lead to more reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.",[29,90,28],"Atherosclerotic Plaque",[92,93,94,95],"drug coated balloon","Near infrared spectroscopy","NIRS-IVUS","De novo coronary lesion","2024-10-09",{"date":98,"type":39},"2024-10-15",{"date":100,"type":39},"2022-10-13",{"date":102,"type":22},"2026-12-31",{"name":104,"class":46},"Korea University Ansan Hospital"]