[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Translumina GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100548400","evaluation-of-the-vivo-isar-stent-system-in-routine-clinical-practice-100548400","NCT06420505","Evaluation of the Vivo Isar Stent System in Routine Clinical Practice","Multicenter Observatory Evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System VIVO ISAR in Routine Clinical Practice (CELEBRITY Observatory)","CELEBRITY","Inclusion Criteria:\n\n* ≥18 years old\n* Ability to provide signed informed consent form.\n* Male or non-pregnant female patient (Pregnancy status to be confirmed verbally from the female patient of reproductive age)\n* Presentation with acute coronary syndrome or chronic coronary syndrome with stable angina or angina equivalent symptoms or with a positive noninvasive test for ischemia or evidence of a functionally significant coronary stenosis.\n* Patient having social security number.\n* Patient treated only with Vivo ISAR stent in case of single or multiple vessel stenting\n\nExclusion Criteria:\n\n* Concurrent participation in another clinical trial.\n* Having benefited from an angioplasty of ≤ 1 month with a stent other than Vivo ISAR.\n* Planned elective surgery in next 6 months\n* Cardiogenic shock\u002F hemodynamically unstable patients\n* Concurrent medical condition with a life expectancy of less than 12 months\n* History of cerebrovascular accident in the last 6 months.\n* Vulnerable patient under guardianship or curatorship",{"count":53,"type":20},3000,"OBSERVATIONAL","The rationale for this observatory is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent System in Real World CAD Patients with follow-up at 12 months. All medications and procedures to be used\u002F performed in this observatory are commonly used\u002Fperformed for clinical indications as part of standard of care and have well-defined safety profiles.",[57],"Artery Coronary Stenosis","2024-06-04",{"date":60,"type":35},"2024-06-06",{"date":62,"type":35},"2023-11-29",{"date":64,"type":20},"2027-01-01",{"name":41,"class":42},19,""]