[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-eluting-balloon\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-eluting-balloon":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,77],{"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":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100635400","stenting-versus-drug-eluting-balloons-only-in-treatment-of-coronary-bifurcation-lesion-robust-study-100635400","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","80 Years",{"count":54,"type":20},272,[23],"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",[58,59,60,27],"Coronary Artery Disease (CAD)","Coronary Bifurcation Lesion","Coronary Stenting",[62,63,64,65],"coronary bifurcation stenting","drug eluting balloon","true coronary bifurcation lesion","coronary artery disease","NOT_YET_RECRUITING","2026-04-20",{"date":69,"type":35},"2026-04-27",{"date":71,"type":20},"2026-06-02",{"date":73,"type":20},"2028-02-20",{"name":75,"class":76},"Avtandil M. Babunashvili","OTHER",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100419550","european-all-comers-multicentric-prospective-registry-on-luminor-drug-eluting-balloon-in-the-superficial-femoral-artery-and-popliteal-artery-with-5-years-follow-up-100419550","NCT04743180","European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.","LUMIFOLLOW","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Rutherford Clinical Category 2-5\n* The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study, voluntarily agrees to participation, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF)\n* Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery\n* TASC II Class A to D Lesions\n* de novo lesion(s), non-stented or stented restenotic lesion(s)\n* Proximal margin of target lesion(s) starts at the ostium of the superficial femoral artery, just below the common femoral bifurcation\n* Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk (P3)\n* A patent inflow artery free from significant lesion (≥ 50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of iliac or common femoral inflow artery lesions); Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication\n* Successful wire crossing and pre-dilatation (1min min, with under sizing of 1mm compared to ref diameter) of the target lesion; Use of crossing devices allowed if necessary. Use of laser or atherectomy is allowed if necessary, during the index procedure. Bailout stenting is allowed if necessary, after DEB use\n* At least one patent native outflow artery to the ankle, free from significant (≥ 50%) stenosis as confirmed by angiography (treatment of outflow disease is NOT permitted during the index procedure)\n\nExclusion Criteria:\n\n* Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children\n* Patient is contraindicated to use Luminor Drug Eluting Balloon per the current Instructions For Use (IFU)\n* Life expectancy of \\\u003C 1year\n* Patient is currently participating in an investigational drug or other device study or previously enrolled in this study\n* Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication\n* Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel",{"count":85,"type":20},500,"60 Months","OBSERVATIONAL","The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and\u002For long lesions\u002Focclusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.",[90,91,92,93,94],"Angioplasty","Peripheral Arterial Disease","Drug-eluting Balloon","Femoral Artery","Paclitaxel","2021-02-10",{"date":97,"type":35},"2021-02-11",{"date":99,"type":35},"2021-01-18",{"date":101,"type":20},"2026-06-30",{"name":103,"class":42},"iVascular S.L.U.",15]