[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-eluting-stent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-eluting-stent":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,81,110,143],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100623531","stents-versus-paclitaxel-coated-balloons-for-revascularization-of-complex-and-small-coronary-vessels-sparx-trial-100623531",false,"NCT07397845","Stents Versus PAclitaxel Coated Balloons for Revascularization of CompleX and Small Coronary Vessels (SPARX) Trial","SPARX RCT","Clinical inclusion criteria:\n\n1. Age≥18 years\n2. Patient with NSTE-ACS or CCS with either symptoms and\u002For ischemia on non-invasive or invasive testing (i.e. FFR\u002FiFR, CMR, SPECT, PET-CT or stress-echo)\n3. The patient must be able to understand and provide written informed consent and comply with all study procedures\n4. Life expectancy of \\> 2 years\n\n   Angiographic inclusion criteria:\n5. One or more trial target vessel (LAD, CX or RCA, or of their branches) with:\n\n   1. Stenosis of ≥70% or\n   2. Stenosis ≥50% and \\\u003C70% (visually assessed) with evidence of ischemia by positive stress test, or FFR ≤0.80, or iFR \\\u003C0.90 or IVUS minimum lumen area ≤4.0 mm2\n6. The target vessel\u002Ftarget lesion matches at least one of the following criteria\n\n   1. Small vessel: vessel reference diameter is ≤ 3 mm\n   2. Long lesions: length ≥ 25 mm\n   3. Calcified lesion: grade 3 by angiography or confirmed on intravascular imaging\n   4. Chronic total occlusion (CTO)\n   5. Bifurcation lesions, including ostial LAD and ostial CX\n   6. Lesions in diabetic coronary artery disease\n   7. In-Stent Restenosis (ISR)\n7. Lesion preparation must be according to the 3rd DCB consensus, with lesions that have:\n\n   1. ≤ 30% residual stenosis\n   2. TIMI (Thrombolysis in Myocardial Infarction) flow grade 3.\n   3. The absence of flow-limiting dissection (Type A-C allowed only)\n\nClinical exclusion criteria:\n\n1. STEMI or cardiogenic shock related to an acute MI within 2 days prior to the index PCI\n2. Pregnancy or nursing declarations (As per country specific guideline) (a negative pregnancy test is required of women with child-bearing potential within 7 days prior to enrollment)\n3. LVEF\\\u003C30%\n4. Known contraindication or hypersensitivity to any limus family drugs, paclitaxel, or to medications such as heparin, aspirin, clopidogrel, ticlopidine, prasugrel and ticagrelor or any component of the devices.\n5. Allergy to imaging contrast media which cannot be adequately pre-medicated\n6. Stroke\u002FTIA during the last 6 months, or any prior intracranial hemorrhage\n7. Active peptic ulcer or upper gastrointestinal bleeding within last 6 months\n8. Known renal insufficiency with an eGFR\\\u003C30 ml\u002Fmin1.73m2, or subject on dialysis, or acute renal failure (as per physician judgment)\n9. Planned surgery within 6 months with the necessity to stop DAPT\n10. History of bleeding diathesis or coagulopathy\n11. Platelet count\\\u003C100.000 cells\u002Fmm3 or \\>400.000 cells\u002Fmm3, a WBC of \\\u003C3000 cells\u002Fmm3, documented or suspected liver disease (including laboratory evidence of hepatitis)\n12. Patient is a recipient of a heart transplant\n13. Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation\n\n    Angiographic exclusion criteria:\n14. Target lesion is in the left main coronary artery\n15. Target lesion is in a coronary artery bypass graft\n16. Flow limiting target vessel thrombus\n17. Evidence of aneurysm in target vessel within 10 mm of the target lesion\n18. Aorto-ostial target lesion (within 3 mm of the aorta junction)","ALL","18 Years",{"count":19,"type":20},1380,"ESTIMATED","INTERVENTIONAL",[23],"NA","The main objective of the SPARX trial is to compare paclitaxel-coated balloons to with contemporary DES in complex and small coronary artery lesions in patients with NSTEACS or CCS; the co-primary objective is to compare two different paclitaxel-coated balloons, Protégé and Agent, with each other.",[26,27,28],"Coronary Artery Disease","Drug Eluting Balloon","Drug Eluting Stent",[14,30],"Protege","RECRUITING","2026-05-27",{"date":34,"type":35},"2026-06-01","ACTUAL",{"date":37,"type":35},"2026-04-22",{"date":39,"type":20},"2029-04",{"name":41,"class":42},"Translumina GmbH","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":43},"100631100","phase-4-optia-af-trial-rhythm-guided-antithrombotic-strategy-after-af-ablation-100631100","NCT07496281","OPTIA-AF Trial: Rhythm-Guided Antithrombotic Strategy After AF Ablation","OPTIA-AF Trial: A Randomized Study of Rhythm-Guided Antithrombotic Strategy After Atrial Fibrillation Ablation in Patients With Prior Drug-Eluting Stent Implantation","OPTIA-AF","1. Inclusion Criteria\n\n   * Participants must meet all of the following criteria:\n   * Age ≥18 years.\n   * Documented history of atrial fibrillation (paroxysmal or persistent).\n   * Successful catheter ablation for atrial fibrillation performed within the previous 3-6 months.\n   * Maintenance of sinus rhythm after ablation, confirmed by follow-up electrocardiography or rhythm monitoring.\n   * History of percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation.\n   * Completion of the recommended duration of dual antiplatelet therapy (DAPT) following PCI.\n   * Currently receiving oral anticoagulation therapy with a non-vitamin K antagonist oral anticoagulant (NOAC).\n   * Clinically stable and considered eligible for long-term antithrombotic therapy adjustment by the treating physician.\n   * Ability to understand the study procedures and provide written informed consent.\n2. Exclusion Criteria\n\n   * Participants will be excluded if any of the following criteria are present:\n   * Recurrent atrial fibrillation documented after the index ablation procedure requiring repeat ablation or antiarrhythmic escalation.\n   * Presence of mechanical heart valve or moderate-to-severe mitral stenosis.\n   * Indication for long-term anticoagulation independent of atrial fibrillation (e.g., venous thromboembolism, mechanical valve).\n   * Recent acute coronary syndrome or PCI within the past 3 months.\n   * Planned coronary revascularization or cardiac surgery.\n   * History of intracranial hemorrhage or other major bleeding that contraindicates antithrombotic therapy.\n   * Severe renal dysfunction (e.g., estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m²).\n   * Severe hepatic dysfunction associated with coagulopathy.\n   * Known hypersensitivity or contraindication to aspirin or NOAC therapy.\n   * Pregnancy or breastfeeding.\n   * Life expectancy less than 1 year due to non-cardiovascular comorbidities.\n   * Participation in another interventional clinical trial that may interfere with the study outcomes.",{"count":53,"type":20},2,[55],"PHASE4","The OPTIA-AF trial is a prospective, multicenter randomized controlled trial designed to evaluate a rhythm-guided antithrombotic strategy in patients with atrial fibrillation (AF) who maintain durable sinus rhythm after catheter ablation and have a history of prior drug-eluting stent (DES) implantation. Current guidelines generally recommend long-term oral anticoagulation (OAC) in patients with AF, even after successful ablation, while antiplatelet therapy remains essential for prevention of coronary ischemic events following percutaneous coronary intervention.\n\nOPTIA-AF tests whether discontinuation of non-vitamin K antagonist oral anticoagulant (NOAC) therapy with transition to single antiplatelet therapy (SAPT) is non-inferior to continued NOAC therapy in patients who maintain sinus rhythm for at least 12 months after AF ablation. Participants will be randomized in a 1:1 ratio to either continued NOAC therapy or NOAC discontinuation with SAPT.\n\nThe primary endpoint is a 24-month composite net clinical outcome including ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding.",[58,26,59],"Atrial Fibrillation (AF)","Drug-eluting Stent",[61,62,63,64,65,66,67,68,69],"Atrial fibrillation ablation","Antithrombotic therapy","Oral anticoagulation","Non-vitamin K antagonist oral anticoagulant","Single antiplatelet therapy","Drug-eluting stent","Rhythm-guided strategy","Catheter ablation","Randomized controlled trial","NOT_YET_RECRUITING","2026-03-23",{"date":73,"type":35},"2026-03-27",{"date":75,"type":20},"2027-03-01",{"date":77,"type":20},"2035-03-01",{"name":79,"class":80},"Ewha Womans University Mokdong Hospital","OTHER",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":43},"100517170","24-versus-12-month-dual-antiplatelet-therapy-after-drug-eluting-stent-in-patients-with-elevated-lipoproteina-levels-a-prospective-multicenter-double-blind-placebo-controlled-randomized-trial-100517170","NCT06014060","24 Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels: A Prospective, Multicenter, Double-Blind, Placebo-Controlled Randomized Trial","DAPT-Lp(a)","Inclusion Criteria:\n\n1. Male or nonpregnant female between 18-75 years;\n2. Subjects with Lp(a) levels \\> 30mg\u002FdL before percutaneous coronary intervention (PCI);\n3. PCI procedure with drug-eluting stent (DES) implantation and no cardiovascular events or BARC type 2, 3, or 5 bleeding events occurring within 12 months after the procedure\n4. Subjects (or legal guardian) understand the trial requirements and the treatment procedures and provides written informed;\n\nExclusion Criteria:\n\n1. Subjects with Lp(a) \\\u003C 30mg\u002FdL or Lp(a) level unavailable before PCI;\n2. Subjects who experience adverse cardiovascular events (death, myocardial infarction, stent thrombosis, stroke, repeat coronary revascularization, or Bleeding Academic Research Consortium \\[BARC\\] type 2, 3 or 5 bleeding) within 1-year after PCI;\n3. BARC type 2, 3, or 5 bleeding occurred before PCI\n4. Unable to tolerate DAPT therapy or anticoagulant therapy at the same time, long-term use of non-steroidal anti-inflammatory drugs is required Or glucocorticoids;\n5. Discontinuation of DAPT for ≥14 days for planned surgical procedures in the next 12 months;\n6. Systolic blood pressure \\\u003C 90mmHg for \\> 30 minutes accompanied by hypoperfusion symptoms or systolic blood pressure ≥ 90mmHg is maintained with mechanical\u002Fpharmacologic hemodynamic support;\n7. Persistent symptoms of myocardial ischemia;\n8. Moderate to severe heart failure (New York Heart Association \\[NYHA\\] Functional Classification III or IV) or last known left ventricular ejection fraction (LVEF) \\\u003C 40%;\n9. Severe valvular heart disease, myocarditis or cardiomyopathy;\n10. Severe hepatic insufficiency (ALT or AST \\> 3 times upper limit of normal, total bilirubin \\> 2.5 times upper limit of normal);\n11. Severe renal dysfunction, defined as creatinine clearance \\\u003C30 mL\u002Fmin or estimated glomerular filtration (eGFR) rate less than 30 ml\u002Fmin\u002F1.73m2, or requirement for peritoneal dialysis or hemodialysis for renal insufficiency;\n12. Severe acute or chronic infectious disease;\n13. History of severe rheumatic immune disease or malignant tumor;\n14. Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies), or receiving other investigational agent(s);\n15. Drug or alcohol abuse, and inability\u002Funwillingness to abstain from drug abuse and excessive alcohol consumption during the study;\n16. Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal);\n17. Known significant active and uncontrolled disease, or any medical, physical condition, as judged by the investigator Or surgical status, may interfere with participation in this study\n18. Mental\u002Fpsychological disorder or any other reason that the subject is expected to have difficulty complying with the study requirements or understanding the participants With the objectives and potential risks of the study;\n19. To the knowledge of the investigator, subjects were unlikely to follow up or were not expected to complete 1 year of follow-up;\n20. Life expectancy is less than 1 year;\n\n22\\. Refusal to participate in the study","75 Years",{"count":90,"type":20},3300,[23],"1. Main objective Among patients with elevated Lp(a) levels (\\>30mg\u002FdL) who did not experience cardiovascular events or BARC type 2, 3, or 5 bleeding within 12 months after PCI and DES implantation, was it possible to reduce the primary adverse cardiovascular and cerebrovascular events (a composite endpoint consisting of all-cause death, non-fatal myocardial infarction, and stroke) by extending the duration of DAPT (24 months) compared to the standard duration (12 months)? (Efficacy test)\n2. Secondary Objectives Key secondary research objective: Among patients with elevated Lp(a) levels (\\> 30mg\u002FdL) who underwent PCI and received DES implantation within 12 months after the procedure, and who did not experience cardiovascular events or BARC type 2, 3, or 5 bleeding, whether extending the DAPT duration (24 months) compared to the standard DAPT duration (12 months) does not result in an increase in clinical net adverse events (a composite endpoint consisting of all-cause death, non-fatal myocardial infarction, stroke, and BARC type 3 or 5 bleeding) compared to the standard DAPT duration. (Non-inferiority test) Other secondary research objectives: To evaluate the differences in the incidence of the composite endpoint consisting of BARC type 3 or 5 bleeding (the primary safety endpoint) between extending the DAPT duration (24 months) and the standard DAPT duration (12 months); the differences in the incidence of the composite endpoint consisting of cardiovascular death and myocardial infarction; the differences in the incidence of the composite endpoint consisting of all-cause death and myocardial infarction; the differences in the incidence of stent thrombosis; the differences in the incidence of any myocardial infarction; the differences in the incidence of target vessel myocardial infarction; the differences in the incidence of stroke; the differences in the incidence of ischemic stroke; the differences in the incidence of hemorrhagic stroke; the differences in the incidence of cardiovascular death; the differences in the incidence of all-cause death; the differences in the incidence of repeat revascularization; the differences in the incidence of target vessel revascularization; the differences in the incidence of BARC type 2, 3, or 5 bleeding; the differences in the incidence of any bleeding.",[94,26,95,96],"Elevated Lipoprotein(a) Level","Drug-Eluting Stent","Dual Antiplatelet Therapy",[98,26,95,99,96],"Lipoprotein(a)","Percutaneous Coronary Intervention","2025-07-16",{"date":102,"type":35},"2025-07-18",{"date":104,"type":35},"2025-06-20",{"date":106,"type":20},"2028-12-31",{"name":108,"class":109},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":129,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100435326","drug-eluting-stenting-and-aggressive-medical-treatment-for-preventing-recurrent-stroke-in-intracranial-atherosclerotic-disease-trial-100435326","NCT04948749","Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial","Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial: a Prospective, Randomized, Open-labelled, Blinded End-point Trial (DREAM-PRIDE)","DREAM-PRIDE","Inclusion Criteria:\n\n1. Age from 18 to 85 years\n2. Patients with ischemic stroke within 30 days of enrolment attributed to 70% to 99% stenosis of a major intracranial artery (internal carotid artery \\[C4-C7\\], middle cerebral artery \\[M1\\], vertebral artery \\[V4\\], or basilar artery) on CTA (According to WASID method)\n3. The diameter of the target vessel between 2.0mm - 4.5mm\n4. The stenosis lesion length ≤ 14 mm\n5. Baseline modified Rankin Scale (mRS) score ≤ 3\n6. Patient understands the purpose and requirements of the study, and has provided informed consent\n\nExclusion Criteria:\n\n1. Ischemic stroke occurred within 7 days before enrolment\n2. Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: an exception is allowed if stenosis or occlusion involves a single vertebral artery proximal to a symptomatic basilar artery stenosis and the contralateral vertebral artery is supplying the basilar artery)\n3. Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which artery is symptomatic (NOTE: an exception is that if bilateral vertebral arteries with 70%-99% stenosis but unequal in size, the dominant side is considered as symptomatic)\n4. Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebral artery\n5. Stroke caused by perforating artery occlusion\n6. CT angiographic evidence of severe calcification at target lesion\n7. Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 6 weeks\n8. Intracranial artery stenosis caused by non-atherosclerotic lesions, including: arterial dissection, Moyamoya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected vasospasm, suspicious embolism recanalization, etc\n9. History of stenting of an intracranial artery\n10. Presence of any unequivocal cardiac source of embolism\n11. Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation\n12. Cannot tolerate dual antiplatelet therapy\n13. Contraindications to heparin, rapamycin, contrast and local or general anesthesia\n14. Hemoglobin\\\u003C100g\u002FL, platelet count \\\u003C100×109\u002FL\n15. Severe hepatic and renal dysfunction\n16. INR\\>1.5 or there are uncorrectable factors leading to bleeding\n17. Major surgery within the past 30 days or planned within 90 days\n18. Renal artery, iliac artery, and coronary artery requiring simultaneous intervention\n19. Life expectancy \\\u003C1 year\n20. Pregnant or lactating women\n21. Cannot complete the follow-up due to cognitive, emotional or mental illness\n22. Other situations that are not suitable for enrolment according to the judgement of the investigator\n23. Enrolment in another study that would conflict with the current study","85 Years",{"count":120,"type":20},792,[23],"The aim of DREAM-PRIDE is to evaluate whether implantation of drug-eluting stent (DES) combined with aggressive medical treatment is more efficacious in prevention of 1-year stroke recurrence than standard medical treatment alone for symptomatic intracranial atherosclerotic disease.",[124,125,59,126,127,128],"ICAD - Intracranial Atherosclerotic Disease","ICAS - Intracranial Atherosclerosis","Stroke","Drug Eluting Stents (DES)","Medical Treatment",[126,66,130,131,132,127],"Medical treatment","ICAD-Intracranial Atherosclerotic Disease","ICAS-Intracranial Atherosclerosis","2024-12-25",{"date":135,"type":35},"2024-12-27",{"date":137,"type":35},"2021-07-02",{"date":139,"type":20},"2026-12",{"name":141,"class":80},"Beijing Tiantan Hospital",18,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":150,"maxAge":4,"enrollmentInfo":151,"targetDuration":153,"studyType":154,"phases":4,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":43},"100521196","efficacy-of-osfit-drug-eluting-stent-in-coronary-ostial-artery-stenosis-100521196","NCT06066450","Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis","Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis: Multi-center, Prospective, Observational Study (OSFIT Registry)","Inclusion Criteria:\n\n1. Age 19 and above.\n2. Patients who have voluntarily decided to participate in this study and have provided written consent in accordance with the subject's agreement.\n3. Patients who have undergone percutaneous coronary intervention for stenosis within 5mm of the ostium of the coronary artery using OSFITTM drug-eluting stents. (In case of simultaneous stent placement for other lesions, only GenossTM drug-eluting stents should be used.)\n\nExclusion Criteria:\n\n1. Patients with contraindications to stent treatment and antiplatelet therapy or who have hypersensitivity.\n2. Patients with a life expectancy of less than 1 year.\n3. Pregnant or lactating women, or those wishing to become pregnant.\n4. Patients with ST-elevation myocardial infarction (STEMI).","19 Years",{"count":152,"type":20},1000,"12 Months","OBSERVATIONAL","The purpose of this observational study is to evaluate the long-term effectiveness and safety of the OSFIT drug-eluting stent designed to facilitate procedures in coronary artery lesions. Additionally, the study aims to verify the accuracy of stent placement in the lesion of interest using Optical Coherence Tomography (OCT) among subgroups of participants.\n\nThe primary endpoint was defined as the composite of target lesion failure (TLF) at the 12-month mark, including cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization.",[59,26],"2023-10-30",{"date":159,"type":35},"2023-11-01",{"date":161,"type":35},"2023-07-07",{"date":163,"type":20},"2026-12-31",{"name":165,"class":42},"Genoss Co., Ltd."]