[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"coronary-bifurcation-lesion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:coronary-bifurcation-lesion":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,77,101,129,151],{"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":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100635400","stenting-versus-drug-eluting-balloons-only-in-treatment-of-coronary-bifurcation-lesion-robust-study-100635400",false,"NCT07552194","Stenting Versus Drug Eluting Balloons Only in Treatment of Coronary Bifurcation Lesion (ROBUST Study)","CompaRison of corOnary BifUrcation Treatment With and Without Stenting Using Only Drug eluTing Balloons (ROBUST Study)","ROBUST","Inclusion Criteria:\n\n* Patients with CCS with documented myocardial ischemia in area supplying by the target coronary artery, not older than 80 years and with an expected life expectancy of at least 1 year\n* Patients with single- or multivessel disease and \"true\" (1.1.1; 1.1.0; and 0.1.1 according to the Medina classification) de novo bifurcation stenosis \\> 50% and \\\u003C100% of the main coronary artery (excluding of the left main) or their large side branches.\n* Both main and side branches should be ≥ 2.0 mm and ≤ 4.5 mm in diameter (according to Quantitative coronary angiography - QCA or intravascular imaging)\n* Length of the main branch lesion should be no more than 30 mm\n* The total length of the side branch should be no more than 7 cm, and the side branch lesion length should be no more than 10 mm\n* Patients without hereditary coagulopathies\n* With a recent (at least 3 months) history of acute coronary syndrome (ACS)\n* Signed informed consent by patient to participate in the study\n\nExclusion Criteria:\n\n* Patients with a single remaining artery supplying a large area of myocardium at risk, regardless of its caliber\n* Over 80 years of age\n* Bifurcation stenosis of the left main coronary artery and bifurcation lesions other than 1.1.1; 1.0.1, and 0.1.1 according to the Medina classification\n* The difference between the proximal and distal reference diameter of the main artery is \\> 1 mm\n* Pregnancy or breastfeeding\n* Severe valvular heart disease requiring surgical or percutaneous intervention within 1 year\n* Life expectancy less than 1 year.\n* Chronic renal failure (glomerular filtration rate less than 30 ml\u002Fmin)\n* Concomitant cancer\n* Heart failure \\> NYHA class II\n* In-stent restenosis in bifurcation lesions after previously performed PCI\n* Presence of thrombus containing Lesion\n* Without concomitant chronic occlusion (bifurcation included in the chronic coronary occlusion (CTO))\n* Patients at high bleeding risk (according to the PRECISE-DAPT score)\n* LV ejection fraction according to echocardiography ≤ 0.4\n* Anemia (Hb \\\u003C 10 g\u002FdL)\n* Thrombocytopenia and any coagulopathy\n* Episodes of significant bleeding and ongoing bleeding requiring modification of medical therapy\n* Acute coronary syndrome\n* PCI or coronary artery bypass grafting (CABG) performed according to clinical indications\n* Patient non-adherence to therapy, including antiplatelet and\u002For anticoagulant medications","ALL","18 Years","80 Years",{"count":21,"type":22},272,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn immediate and follow up results of percutaneous treatment of coronary bifurcation lesion using drug eluting balloons (DEB) only in patients with chronic coronary syndrome (CCS). Researchers will compare endovascular treatment using solely DEB to stenting of coronary bifurcation lesion. The main questions it aims to answer are:\n\n* What is immediate and follow up clinical and angiographic results of endovascular treatment of coronary bifurcation lesion using DEB in patients with CCS?\n* Is efficacy and safety of endovascular treatment of coronary bifurcation lesion using DEB only in patients with CCS non inferior to compare stenting of aforementioned lesion which is contemporary recommended standard of care?\n\nParticipants will:\n\n* Take prescribed medication before and after initial procedure during whole observation period (12 months)\n* Visit the clinic at 1, 6 and 12 months after the initial procedure for checkup, noninvasive tests and control angiography at 12 months follow up\n* Inform researchers about all adverse events that might be occur during follow up observation period",[28,29,30,31],"Coronary Artery Disease (CAD)","Coronary Bifurcation Lesion","Coronary Stenting","Drug Eluting Balloon",[33,34,35,36],"coronary bifurcation stenting","drug eluting balloon","true coronary bifurcation lesion","coronary artery disease","NOT_YET_RECRUITING","2026-04-20",{"date":40,"type":41},"2026-04-27","ACTUAL",{"date":43,"type":22},"2026-06-02",{"date":45,"type":22},"2028-02-20",{"name":47,"class":48},"Avtandil M. Babunashvili","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100579286","the-european-bifurcation-club-randomized-trial-of-stepwise-provisional-stenting-versus-drug-coated-balloon-therapy-for-non-left-main-true-coronary-bifurcations-100579286","NCT06822322","The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations","The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations - EBC DCB Study","EBC DCB","Inclusion Criteria:\n\n* True non-left main bifurcation disease with both MV and SB involvement (i.e Medina 1\u002F1\u002F1, 1\u002F0\u002F1, 0\u002F1\u002F1)\n* Bifurcation lesion responsible for an acute or chronic coronary syndrome with at least one of the following:\n\n  * ≥70% angiographic MV and SB diameter stenosis\n  * Positive non-invasive testing for ischaemia\n  * Positive coronary physiology for ischaemia\n* Significant SB as described by diameter stenosis ≥50% and all of the following:\n\n  * SB length ≥73mm\n  * SB diameter ≥2.5mm\n  * Absence of another SB emerging distally from the MV\n  * Non-dominant circumflex artery, if SB is a diagonal branch.\n\nExclusion criteria\n\n* Patients \\\u003C18 years old\n* STEMI \\\u003C48 hours\n* Cardiogenic shock\n* Chronic total occlusion involving target bifurcation vessels\n* In-stent restenosis\n* Patient life expectancy \\\u003C12 months\n* \\>2 other coronary lesions (target or non-target) planned for treatment\n* SYNTAX score \\>32\n* Platelet count ≤50x109\u002Fmm3\n* Left ventricular ejection fraction ≤20%\n* Participation in another investigational drug or device study\n* Patient unable to give informed consent",{"count":58,"type":22},750,[25],"Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Thus, the primary objective of this study is to determine if Drug Coated Balloon treatment of non-left main true coronary artery bifurcation lesions is non-inferior (similar) to a provisional strategy with Drug Eluted Stent deployment.",[62,29],"Coronary Artery Disease (non-left Main)",[64,65,66],"non-left coronary bifurcation","drug coated balloon","drug eluted stent","2025-02-13",{"date":69,"type":41},"2025-02-14",{"date":71,"type":22},"2025-05",{"date":73,"type":22},"2035-08",{"name":75,"class":76},"Ceric Sàrl","INDUSTRY",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100563598","efficacy-and-safety-of-sirolimus-coated-spiral-balloon-for-coronary-bifurcation-lesions-100563598","NCT06618248","Efficacy and Safety of Sirolimus-Coated Spiral Balloon for Coronary Bifurcation Lesions","A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of the Sirolimus-coated Spiral Balloon Catheter for the Treatment of Coronary Bifurcation Lesions","Inclusion Criteria:\n\n* Patients aged between 18 and 85 years, regardless of gender.\n* Patients must voluntarily participate in the study and sign an informed consent form.\n* Patients must demonstrate sufficient adherence to the study protocol and agree to follow-up visits at 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) post-procedure, with angiography required at 9 months (±30 days).\n* Patients must have evidence of myocardial ischemia.\n* Angiographically confirmed primary coronary bifurcation lesions (Medina classification non-0, 0, 1) with branch stenosis ≥70% (estimated visually).\n* Patients suitable for PCI where the branch lesion is not expected to require stenting; stenting is planned for the main vessel, with DCB used on the branch. It is recommended to treat the branch with DCB first, followed by main vessel stenting.\n* Residual stenosis ≤50% after pre-treatment of the branch lesion, TIMI 3 flow, with no dissection or only A or B grade dissection. C grade dissections should be carefully considered by the investigator before deciding, and are generally not included.\n* The diameter of the branch vessel must be between 2.0 mm and 4.0 mm, with a lesion length ≤40 mm.\n\nExclusion Criteria:\n\n* Patients with bleeding disorders or active gastrointestinal ulcers, those who have had a stroke within the past 6 months, or those who are expected to be intolerant to dual antiplatelet therapy post-intervention.\n* Patients with severe renal insufficiency (creatinine level \\> 3.0 mg\u002FdL or 265.2 µmol\u002FL) and\u002For end-stage renal disease requiring dialysis.\n* Patients in cardiogenic shock.\n* Patients who have experienced a myocardial infarction within the week prior to enrollment.\n* Patients with severe congestive heart failure or NYHA class IV severe heart failure.\n* Patients with severe valvular heart disease.\n* Patients who have undergone heart transplantation.\n* Patients with a life expectancy of less than 1 year.\n* Patients currently participating in other drug or device clinical trials that have not yet reached the primary endpoint.\n* Patients with contraindications to taking aspirin and\u002For clopidogrel and\u002For ticagrelor.\n* Patients known to be allergic to paclitaxel, rapamycin, contrast agents, etc.\n* Pregnant or breastfeeding women, those with plans to conceive within the year, or those unwilling to use effective contraception.\n* Target vessels that are completely occluded, severely calcified, have \\>45° angulation, or are non-protected left main lesions.\n* Non-target lesions that cannot be treated prior to or fail to be treated successfully before addressing the target lesion.\n* Target lesions in branch vessels that are in-stent restenosis.\n* Other patients deemed unsuitable for inclusion by the investigator.","85 Years",{"count":86,"type":22},280,[25],"This is a multicenter, prospective randomized controlled study to evaluate the safety and effectiveness of Sirolimus-coated spiral balloon (SuperFlow®) versus Paclitaxel-coated balloon (Bingo™) in the treatment of coronary bifurcation lesions.",[29],"RECRUITING","2024-09-28",{"date":93,"type":41},"2024-10-01",{"date":95,"type":41},"2023-12-20",{"date":97,"type":22},"2027-03",{"name":99,"class":76},"Dongguan TT Medical",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":100},"100495476","bifurcation-pci-with-a-hybrid-strategy-with-drug-eluting-balloons-versus-a-stepwise-provisional-two-stent-strategy-100495476","NCT05731687","Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy","Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy. A Randomized Controlled Trial and Registry","Hybrid DEB","Inclusion Criteria:\n\n* Significant de novo bifurcation lesion (main vessel and side branch diameter ≥ 2.5mm, diameter stenosis of the main vessel ≥ 70% and of the side branch ≥ 50% or in intermediate stenosis FFR ≤ 0.80 or iFR ≤ 0.89)\n* Stable coronary artery disease or stabilized acute coronary syndrome\n* Age ≥ 18 years\n* Acceptable candidate for treatment with a drug eluting stent\n\nExclusion Criteria:\n\n* Unstable clinical condition\n* Previous PCI with stent implantation in the target lesion(s)\n* Known comorbidity with a life expectancy of \\\u003C2 year\n* Active bleeding requiring medical attentions (BARC \\>2 at index PCI)\n* Pregnancy\n* Unable to provide consent for any other reason\n* Participation in another stent or drug trial\n* Known hypersensitivity or allergy for asprin, clopidogrel, ticagrelor, prasugrel, cobalt chromium, sirolimus, to excipients with phospholipid or related origins.",{"count":110,"type":22},500,[25],"The optimal treatment of coronary bifurcation lesions is complex and remains subject of current research. There is ongoing debate about the optimal strategy for bifurcations with upfront two-stent strategy or provisional one-stent strategy. Current European Society of Cardiology (ESC) guidelines advise a provisional approach with optional stepwise two-stent strategy in case of suboptimal result of the side branch (SB). However, a two-stent strategy (either upfront and stepwise) caries technical difficulties and is associated with increased procedure duration and costs and higher exposure of the patient to radiation and contrast. Therefore there is upcoming interest in the use of a drug-eluting balloon (DEB) in the side branch of bifurcation lesions after provisional approach. Drug-eluting balloons are conventional semi-compliant angioplasty balloons covered with an anti-proliferating drug, which is released into the vessel wall during inflation.\n\nSeveral small pilot studies have successfully investigated a hybrid approach with use of DEB in addition to the provisional strategy. This hybrid approach has shown to be safe and feasible, however no large trials have been performed comparing this with current two-stent bifurcation strategies.\n\nThe aim of this randomized controlled, single blinded, multicenter trial is to investigate whether a hybrid DEB approach is non-inferior to a stepwise provisional two-stent strategy in patients with de novo bifurcation lesions and a suboptimal result of the SB after provisional approach.\n\nPatients included in this study will receive PCI using provisional approach (implantation of drug-eluting stent (DES) in the main branch). Patients with an unsatisfactory result of the SB after provisional PCI (≥ 70% residual stenosis and\u002For diminished flow \\\u003C Thrombolysis in Myocardial Infarction (TIMI) III) will be randomized in a 1:1 ratio to receive the Hybrid DEB approach or the two-stent strategy. Patients with a satisfactory result of the side branch after provisional PCI will be included in a registry.\n\nFollow-up will be performed at 12 months and at the anticipated median 2 year follow-up with a minimum follow-up of 1 year in each subject by either a phone call or outpatient clinic visit. During follow-up information regarding cardiovascular drug use, hospitalizations, invasive and non-invasive diagnostic tests, angina status and SAE's is obtained.",[114,29],"Coronary Artery Disease",[116,117,118,119],"Coronary bifurcation lesion","Coronary artery disease","Drug-eluting balloon","Percutaneous coronary intervention","2023-12-08",{"date":122,"type":41},"2023-12-15",{"date":124,"type":41},"2023-03-21",{"date":126,"type":22},"2030-03",{"name":128,"class":48},"Cathreine BV",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100398725","latam-bif-registry-100398725","NCT04471883","LATAM Bif Registry","Latin American Registry of Percutaneous Interventions in Coronary Bifurcations","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Any type of bifurcation lesion\n* Side-branch reference diameter \\>= 2 mm\n\nExclusion Criteria:\n\n* Protected left main disease in patients with previous CABG\n* Patients who refuse to be included in the registry",{"count":137,"type":22},5000,"OBSERVATIONAL","The LATAM Bif Registy is an international and prospective registry of percutaneous coronary interventions (PCI) in coronary bifurcation lesions. The main goal of the study is to investigate the current state and long-term outcomes of PCI in this complex subset of coronary lesions in Latin America.",[29],"2020-07-10",{"date":143,"type":41},"2020-07-15",{"date":145,"type":22},"2020-08-15",{"date":147,"type":22},"2030-08-15",{"name":149,"class":150},"LATAM Bifurcation Club","NETWORK",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":159,"enrollmentInfo":160,"targetDuration":161,"studyType":138,"phases":4,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":100},"100320343","international-bifurcation-study-100320343","NCT03450577","International Bifurcation Study","International Prospective Register on Treatment of Coronary Artery Bifurcation Lesions","IBS","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Any type of bifurcation lesion in major epicardial artery\n\nExclusion Criteria:\n\n* Patient refused informed consent to participate in the registry","100 Years",{"count":137,"type":22},"5 Years","The IBS registry is an observational, multi-center, real-world registry of stenting in coronary bifurcation lesions that will collect information on procedures and outcomes from various participating centers.\n\nThe aim of this registry is to investigate long-term clinical results and predictors of adverse outcomes after PCI for coronary bifurcation lesions among various participating centers.",[29],"2019-03-07",{"date":166,"type":41},"2019-03-11",{"date":168,"type":41},"2018-01-01",{"date":170,"type":22},"2026-12-31",{"name":172,"class":150},"Meshalkin Research Institute of Pathology of Circulation"]