[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544800":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":196,"collaborators":25,"id":198,"slug":199,"hasResults":200,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":200,"sex":206,"minAge":207,"maxAge":25,"enrollmentInfo":208,"targetDuration":25,"studyType":211,"phases":212,"briefSummary":214,"conditions":215,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},{"fullName":5,"class":6},"Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"sirolimus-eluting balloon (Selution)","EXPERIMENTAL","DCB angioplasty with a sirolimus-eluting balloon",[13],"Device: sirolimus-eluting balloon (Selution)",{"label":15,"type":16,"description":17,"interventionNames":18},"paclitaxel-eluting balloon (SeQuent Please Neo)","ACTIVE_COMPARATOR","DCB angioplasty with a paclitaxel-eluting balloon",[19],"Device: paclitaxel-eluting balloon (SeQuent Please Neo)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","PCI treatment with DCB, in particular sirolimus coated balloon",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"PCI treatment with DCB, in particular paclitaxel coated balloon",[15],[30],{"name":31,"affiliation":32,"role":33},"Antonio AC Colombo, MD","Fondazione Evidence ONLUS","STUDY_CHAIR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Marina MCS Cornacchia Schenetti","CONTACT","03761810406","schema1950@gmail.com",{"name":41,"role":37,"phone":25,"phoneExt":25,"email":42},"Riccardo RF Falzone","spagostudy@we4cr.com",[44,63,78,93,104,119,133,148,163,180],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Clinica Montevergine","RECRUITING","Mercogliano","Italy\u002FAvellino","83013","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],14.74491,40.92157,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":61,"phoneExt":25,"email":62},"Tullio Tesorio, MD","0825 7051130","tulliotesorio@gmail.com",{"facility":64,"status":46,"city":65,"state":66,"zip":67,"country":50,"countryCode":51,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"ASST Papa Giovanni XXIII","Bergamo","Italy\u002FBergamo","24127",{"type":53,"coordinates":69},[70,71],9.66721,45.69601,{"lat":71,"lon":70},[74],{"name":75,"role":37,"phone":76,"phoneExt":25,"email":77},"Luigi Fiocca, 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Monzino","Milan","Italy\u002FMilano","20138",{"type":53,"coordinates":110},[111,112],12.59836,42.78235,{"lat":112,"lon":111},[115],{"name":116,"role":37,"phone":117,"phoneExt":25,"email":118},"Stefano Galli, MD","0258002533","stefano.galli@cardiologicomonzino.it",{"facility":120,"status":46,"city":121,"state":107,"zip":122,"country":50,"countryCode":51,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Istituto Clinico Humanitas","Rozzano","20089",{"type":53,"coordinates":124},[125,126],9.1559,45.38193,{"lat":126,"lon":125},[129],{"name":130,"role":37,"phone":131,"phoneExt":25,"email":132},"Antonio Mangieri, MD","0282244330","antonio.mangieri@gmail.com",{"facility":134,"status":46,"city":135,"state":136,"zip":137,"country":50,"countryCode":51,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Clinica Mediterranea","Naples","Italy\u002FNapoli","80122",{"type":53,"coordinates":139},[140,141],14.26811,40.85216,{"lat":141,"lon":140},[144],{"name":145,"role":37,"phone":146,"phoneExt":25,"email":147},"Carlo Briguori, MD","0817259704","carlo.briguori@gmail.com",{"facility":149,"status":46,"city":150,"state":151,"zip":152,"country":50,"countryCode":51,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Azienda Ospedaliero Universitaria San Luigi Gonzaga","Orbassano","Italy\u002FTorino","10043",{"type":53,"coordinates":154},[155,156],7.53813,45.00547,{"lat":156,"lon":155},[159],{"name":160,"role":37,"phone":161,"phoneExt":25,"email":162},"Marco Pavani, MD","011 9551425","marcopavani@alice.it",{"facility":164,"status":46,"city":165,"state":151,"zip":166,"country":50,"countryCode":51,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Ospedale di Rivoli","Rivoli","10098ù",{"type":53,"coordinates":168},[169,170],7.51465,45.07073,{"lat":170,"lon":169},[173,177],{"name":174,"role":37,"phone":175,"phoneExt":25,"email":176},"Alfonso Franzè, MD","0119026803","emodinamica@sanluigi.piemonte.it",{"name":178,"role":179,"phone":25,"phoneExt":25,"email":25},"Ferdinando Varbella, MD","SUB_INVESTIGATOR",{"facility":181,"status":182,"city":183,"state":184,"zip":185,"country":50,"countryCode":51,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Ospedale Sant'Andrea","NOT_YET_RECRUITING","Vercelli","Italy\u002FVercelli","13100",{"type":53,"coordinates":187},[188,189],8.41989,45.32163,{"lat":189,"lon":188},[192],{"name":193,"role":37,"phone":194,"phoneExt":25,"email":195},"Fabrizio Ugo, MD","0161593124","ugo.fabrizio@libero.it",{"type":197,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100544800","spago-sirolimus-paclitaxel-angiographic-gain-objective-100544800",false,"NCT06373601","SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective","Selution Sirolimus Coated Balloon (MedAlliance) Versus SeQuent Please Neo Paclitaxel Coated Balloon (Bbraun) for the Treatment of de Novo Coronary Artery Lesions in Medium-small Size Vessels.","SPAGO","Inclusion Criteria:\n\n1. Male or female subjects ≥18 years\n2. Subject with chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values.\n3. The subject has at least one de-novo lesion in a small vessel (\\>2.00 mm and ≤3.00 mm prior to pre-dilatation) with a diameter stenosis between 50% and 99% (prior to pre-dilatation). It is possible to enroll subjects that have a stent previously implanted in the same epicardial territory (main vessel and ramifications) of the target lesion\n4. Patients with target lesion to be treated with DCB \\\u003C 30 mm in length (up to 40 patients) or with DCB ≥ 30 mm in length (at least 100 patients)\n5. Able to understand and provide informed consent and comply with all study procedures including 12 months angiographic follow-up\n6. Subject must have completed the follow-up phase of any previous study\n\nExclusion Criteria:\n\n1. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)\n2. Evidence of ongoing acute myocardial infarction (AMI) in ECG and\u002For elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure\n3. Known contraindication or hypersensitivity to sirolimus, paclitaxel, or to medications such as aspirin, heparin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor\n4. Subjects who experienced a previous PCI with DCB in the epicardial territory (main vessel and ramifications) where the target lesion is located, during the last 12 months\n5. Subject suffered from stroke\u002FTIA during the last 6 months\n6. LVEF \\\u003C30%\n7. Platelet count \\\u003C100,000 cells\u002Fmm3 or \\>400,000 cells\u002Fmm3, a WBC of \\\u003C3,000 cells\u002Fmm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)\n8. Known renal insufficiency (e.g. serum creatinine \\>2,5 mg\u002FdL, creatinine clearance ≤30 mL\u002Fmin or eGFR ≤30 mL\u002Fmin\u002Fm2), or subject on dialysis, or acute kidney failure (as per physician judgment)\n9. Subject undergoing planned surgery within 1 month with the necessity to stop DAPT\n10. History of bleeding diathesis or coagulopathy\n11. The subject is a recipient of a heart transplant\n12. Concurrent medical condition with a life expectancy of less than 12 months\n13. The subject is unwilling\u002Fnot able to return for angiographic re-catheterisation at 12 months follow-up\n14. Currently participating in another trial\n\n    Angiographic exclusion criteria:\n15. Target vessel size \\>3.00 mm\n16. Target vessel size ≤2.00 mm\n17. Target lesion has a diameter stenosis \\\u003C 50% prior to pre-dilatation\n18. Target lesion has a total occlusion or TIMI flow \\\u003C 2 prior to pre-dilatation\n19. Pre-dilatation of the target lesion not performed or not successful (residual stenosis \\> 30%, TIMI flow \\\u003C 3 and presence of major angiographic dissections)\n20. Target lesion in left main stem\n21. The target vessel contains visible thrombus\n22. Aorto-ostial target lesion (within 3 mm of the aorta junction)\n23. Lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft","ALL","18 Years",{"count":209,"type":210},140,"ESTIMATED","INTERVENTIONAL",[213],"NA","The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (\\>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) and Fractional Flow Reserve (FFR) at 12 months follow-up.",[216,217,218,219],"Coronary Artery Disease","Stenosis Coronary","Coronary Artery Lesion","Percutaneous Coronary Intervention","2025-11-25",{"date":222,"type":223},"2025-12-03","ACTUAL",{"date":225,"type":223},"2024-09-05",{"date":227,"type":210},"2027-08-01",{"name":5,"class":6},10]