[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642157":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":41,"locations":46,"responsibleParty":274,"collaborators":277,"id":281,"slug":282,"hasResults":283,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":283,"sex":289,"minAge":290,"maxAge":40,"enrollmentInfo":291,"targetDuration":40,"studyType":294,"phases":295,"briefSummary":297,"conditions":298,"keywords":301,"overallStatus":308,"whyStopped":40,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},{"fullName":5,"class":6},"University of Mons","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard NC group","ACTIVE_COMPARATOR","Lesion preparation of calcified coronary stenosis performed using standard non-compliant (NC) balloons. Balloons are sized according to a 0.8:1 to 1:1 ratio relative to the reference lumen and inflated below the rated burst pressure. To maintain a strict comparison and eliminate any scoring effect, no parallel guidewire is allowed in the target vessel during inflation.",[13],"Device: Non-Compliant (NC) Angioplasty Balloon",{"label":15,"type":16,"description":17,"interventionNames":18},"Naviscore group","EXPERIMENTAL","Lesion preparation of calcified coronary stenosis performed using the Naviscore scoring balloon catheter before drug-eluting stent implantation. The device is sized according to a 0.8:1 to 1:1 ratio relative to the reference lumen. To maximize the plaque-modification effect of the external nitinol wires, a mandatory mechanical mobilization sequence must be performed: the balloon is inflated to nominal pressure, fully deflated, mobilized within the lesion, and reinflated. This specific sequence must be repeated 3 to 4 times across the target segment.",[19],"Device: Scoring Balloon PTCA Catheter",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Scoring Balloon PTCA Catheter","Percutaneous coronary preparation of calcified coronary stenosis using the rapid exchange Naviscore scoring balloon catheter before drug-eluting stent deployment. The device incorporates an over-the-balloon metallic nitinol element designed to focally concentrate dilation forces, minimizing balloon slippage and scoring the atheromatous plaque at lower pressures to facilitate optimal stent expansion. Sizing is based on a 0.8:1 to 1:1 ratio relative to the reference lumen. Operators must execute a specific sequence of inflating the scoring balloon to nominal pressure, fully deflating it, mobilizing it within the lesion, and reinflating it, repeated three to four times across the target segment to ensure multi-focal plaque disruption before stenting.",[15],[27],"Naviscore Scoring Balloon",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Non-Compliant (NC) Angioplasty Balloon","Conventional non-compliant (NC) PTCA balloon catheter used for standard lesion pre-dilatation according to routine clinical practice, inflated below the rated burst pressure without parallel guidewires in place.",[9],[33],"Conventional PTCA Balloon",[35,38],{"name":36,"affiliation":5,"role":37},"Stéphane Carlier, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"Antonio Serra",null,[42],{"name":36,"role":43,"phone":44,"phoneExt":40,"email":45},"CONTACT","+3265373381","stephane.carlier@umons.ac.be",[47,64,73,88,103,122,138,154,172,191,204,219,235,254],{"facility":48,"status":40,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"CHU - HELORA site Kennedy","Mons","Hainaut","7000","Belgium","BE",{"type":55,"coordinates":56},"Point",[57,58],3.95229,50.45413,{"lat":58,"lon":57},[61,62],{"name":36,"role":43,"phone":44,"phoneExt":40,"email":45},{"name":63,"role":37,"phone":40,"phoneExt":40,"email":40},"Stéphane Carlier, MD, Phd",{"facility":65,"status":40,"city":66,"state":40,"zip":67,"country":52,"countryCode":53,"cosmosGeoPoint":68,"geoPoint":72,"contacts":40},"Imelda","Bonheiden","2820",{"type":55,"coordinates":69},[70,71],4.54714,51.02261,{"lat":71,"lon":70},{"facility":74,"status":40,"city":75,"state":40,"zip":76,"country":52,"countryCode":53,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Hôpital Erasme - Cliniques universitaires de Bruxelles","Brussels","1070",{"type":55,"coordinates":78},[79,80],4.34878,50.85045,{"lat":80,"lon":79},[83,87],{"name":84,"role":43,"phone":85,"phoneExt":40,"email":86},"Gabriela Flores Vivian, MD","+3225554290","g.floresvivian@hubruxelles.be",{"name":84,"role":37,"phone":40,"phoneExt":40,"email":40},{"facility":89,"status":40,"city":90,"state":40,"zip":91,"country":52,"countryCode":53,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Hôpital Vivalia","Libramont","6800",{"type":55,"coordinates":93},[94,95],5.37318,49.91741,{"lat":95,"lon":94},[98,102],{"name":99,"role":43,"phone":100,"phoneExt":40,"email":101},"Chadi Ghafari, MD, PhD","+32483128996","chadi_ghafari@yahoo.com",{"name":99,"role":37,"phone":40,"phoneExt":40,"email":40},{"facility":104,"status":40,"city":105,"state":40,"zip":106,"country":52,"countryCode":53,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"CHR de la Citadelle","Liège","4000",{"type":55,"coordinates":108},[109,110],5.56749,50.63373,{"lat":110,"lon":109},[113,117,121],{"name":114,"role":43,"phone":115,"phoneExt":40,"email":116},"Georges Saad, MD","+3243217155","georges.saad@citadelle.be",{"name":118,"role":43,"phone":119,"phoneExt":40,"email":120},"Sophie Jacquet","+3243217820","rc-cardio@citadelle.be",{"name":114,"role":37,"phone":40,"phoneExt":40,"email":40},{"facility":123,"status":40,"city":124,"state":40,"zip":125,"country":52,"countryCode":53,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Humani CHU Charleroi - Chimay","Lodelinsart","6042",{"type":55,"coordinates":127},[128,129],4.44886,50.43138,{"lat":129,"lon":128},[132,136],{"name":133,"role":43,"phone":134,"phoneExt":40,"email":135},"Cellule de recherche clinique","+32071920545","cellule.recherche.clinique@humani.be",{"name":137,"role":37,"phone":40,"phoneExt":40,"email":40},"Mohamed Ben Yedder, MD",{"facility":139,"status":40,"city":140,"state":40,"zip":141,"country":140,"countryCode":142,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"INCCI Haerz Zenter","Luxembourg","1210","LU",{"type":55,"coordinates":144},[145,146],6.13268,49.60982,{"lat":146,"lon":145},[149,153],{"name":150,"role":43,"phone":151,"phoneExt":40,"email":152},"Bruno Pereira, MD","+ 352 691 86 31 86","dr.pereira@pt.lu",{"name":150,"role":37,"phone":40,"phoneExt":40,"email":40},{"facility":155,"status":40,"city":156,"state":40,"zip":157,"country":158,"countryCode":159,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Centro Hospitalar de Vila Nova de Gaia\u002FEspinho","Vila Nova de Gaia","4430-999","Portugal","PT",{"type":55,"coordinates":161},[162,163],-8.61241,41.12401,{"lat":163,"lon":162},[166,170],{"name":167,"role":43,"phone":168,"phoneExt":40,"email":169},"Alberto Rodrigues","+351919589753","rodrigues.jal@gmail.com",{"name":171,"role":37,"phone":40,"phoneExt":40,"email":40},"Alberto Rodrigues, MD",{"facility":173,"status":40,"city":174,"state":40,"zip":175,"country":176,"countryCode":177,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Hospital de Sant Pau","Barcelona","08025","Spain","ES",{"type":55,"coordinates":179},[180,181],2.15899,41.38879,{"lat":181,"lon":180},[184,188,190],{"name":185,"role":43,"phone":186,"phoneExt":40,"email":187},"Estefanía Fernández-Peregrina, MD","+34628839525","efernandezpe@santpau.cat",{"name":189,"role":43,"phone":186,"phoneExt":40,"email":40},"Elena Jiménez Xarrié",{"name":185,"role":37,"phone":40,"phoneExt":40,"email":40},{"facility":192,"status":40,"city":174,"state":40,"zip":193,"country":176,"countryCode":177,"cosmosGeoPoint":194,"geoPoint":196,"contacts":197},"Hospital Universitari de Bellvitge","08901-08908",{"type":55,"coordinates":195},[180,181],{"lat":181,"lon":180},[198,202],{"name":199,"role":43,"phone":200,"phoneExt":40,"email":201},"Andrea Ruberti","+34 932 60 75 00","andreaalbertoruberti@bellvitgehospital.cat",{"name":203,"role":37,"phone":40,"phoneExt":40,"email":40},"Andrea Ruberti, MD",{"facility":205,"status":40,"city":206,"state":40,"zip":207,"country":176,"countryCode":177,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Hospital Puerta Del Mar","Cadiz","11009",{"type":55,"coordinates":209},[210,211],-6.2891,36.52672,{"lat":211,"lon":210},[214,218],{"name":215,"role":43,"phone":216,"phoneExt":40,"email":217},"Alejandro Gutiérrez-Barrios, MD","+34 620688877","aleklos@hotmail.com",{"name":215,"role":37,"phone":40,"phoneExt":40,"email":40},{"facility":220,"status":40,"city":221,"state":40,"zip":222,"country":176,"countryCode":177,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Hospital San Pedro de Alcantara","Cáceres","10003",{"type":55,"coordinates":224},[225,226],-6.37224,39.47649,{"lat":226,"lon":225},[229,233],{"name":230,"role":43,"phone":231,"phoneExt":40,"email":232},"Juan Carlos Rama","+34615611413","ramamerchan@hotmail.com",{"name":234,"role":37,"phone":40,"phoneExt":40,"email":40},"Juan Carlos Rama, MD",{"facility":236,"status":40,"city":237,"state":40,"zip":238,"country":176,"countryCode":177,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"Hospital La Fe","Valencia","46026",{"type":55,"coordinates":240},[241,242],-0.37966,39.47391,{"lat":242,"lon":241},[245,249,252],{"name":246,"role":43,"phone":247,"phoneExt":40,"email":248},"Jorge Sanz Sanchez","+34 660360598","sjorge4@gmx.com",{"name":250,"role":43,"phone":40,"phoneExt":40,"email":251},"Ines Roche Fortea","ines_roche@islafe.es",{"name":253,"role":37,"phone":40,"phoneExt":40,"email":40},"Jorge Sanz Sanchez, MD",{"facility":255,"status":40,"city":256,"state":40,"zip":257,"country":176,"countryCode":177,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"Hospital Clínico Universitario de Valladolid","Valladolid","47003",{"type":55,"coordinates":259},[260,261],-4.72353,41.65541,{"lat":261,"lon":260},[264,269,273],{"name":265,"role":43,"phone":266,"phoneExt":267,"email":268},"Ignacio J Amat Santos, MD","+34983420000","86571","ijamat@gmail.com",{"name":270,"role":43,"phone":271,"phoneExt":267,"email":272},"Carlos Baladrón Zorita","+34983 42 00 00","cbaladron@icicor.es",{"name":265,"role":37,"phone":40,"phoneExt":40,"email":40},{"type":37,"investigatorFullName":275,"investigatorTitle":276,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Stephane Carlier","Principal Investigator",[278],{"name":279,"class":280},"iVascular S.L.U.","INDUSTRY","100642157","evaluation-of-calcified-coronary-lesion-preparation-with-the-naviscore-scoring-balloon-100642157",false,"NCT07650578","Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon","MILOU: Minimize Intra Luminal Obstructive Underexpansion: A Prospective, Multi-Center Randomized Trial for the Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon","MILOU","Inclusion Criteria:\n\n* Patient written consent is given, ≥18 years.\n* A de novo lesion to be treated in a vessel between 2.5 and 4.0 mm.\n* Moderate to heavily calcified lesions detected by coronary angiography on two orthogonal views, and confirmed by IVUS if the lesion can be crossed with the catheter.\n\nExclusion Criteria:\n\n* Patient \\\u003C18 years old.\n* Pregnant female.\n* Contraindication to dual antiplatelet therapy.\n* Thrombocytopenia (under 100 000).\n* Major surgical intervention planned within one year.\n* Significant left main lesion.\n* Chronic total occlusion.\n* Lesion in a graft.\n* In-stent restenosis lesion.\n* Lesion responsible of a ST elevated Myocardial Infarction (STEMI)","ALL","18 Years",{"count":292,"type":293},200,"ESTIMATED","INTERVENTIONAL",[296],"NA","The purpose of this clinical study is to evaluate the effectiveness and safety of a specialized medical device, the Naviscore scoring balloon, in preparing calcified coronary artery narrowings before the implantation of a drug-eluting stent. During percutaneous coronary interventions, the presence of calcified plaques in the heart arteries represents a major challenge because it can prevent stents from expanding fully. When a stent remains under-expanded, it significantly increases the long-term risk of arterial re-narrowing or blood clot formation. To optimize stent expansion, appropriate preparation of the diseased vessel section before stent insertion is a critical phase.\n\nThis study is a prospective, multi-center randomized trial designed to test the hypothesis that treating calcified coronary lesions with the Naviscore scoring balloon will achieve a better stent expansion and a larger final minimal stent area compared to standard lesion preparation using regular non-compliant balloons. Eligible participants will be randomized in a one-to-one ratio to one of these two lesion preparation strategies. For all included patients, standard drug-eluting stents will be deployed. The study will use intravascular ultrasound imaging to evaluate the final minimum area of the stent directly inside the treated artery at the site of the highest initial calcium burden. Participant health and clinical outcomes will be monitored for up to twelve months following the procedure.",[299,300],"Coronary Arterial Disease (CAD)","Calcific Coronary Arteriosclerosis",[302,303,304,305,306,307],"Percutaneous Coronary Intervention","Lesion Preparation","Scoring Balloon","Intravascular Ultrasound","Stent Expansion","Coronary Artery Calcification","NOT_YET_RECRUITING","2026-06-10",{"date":311,"type":312},"2026-06-16","ACTUAL",{"date":314,"type":293},"2026-07",{"date":316,"type":293},"2028-06",{"name":5,"class":6},14]