[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544458":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":46,"responsibleParty":357,"collaborators":359,"id":369,"slug":370,"hasResults":371,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":371,"sex":377,"minAge":378,"maxAge":11,"enrollmentInfo":379,"targetDuration":11,"studyType":382,"phases":383,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":402},{"fullName":5,"class":6},"Deutsches Herzzentrum Muenchen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lesion preparation using coronary intravascular lithotripsy","EXPERIMENTAL",null,[13],"Device: Intravascular lithotripsy (IVL)",{"label":15,"type":16,"description":17,"interventionNames":18},"Lesion preparation using other methods than intravascular lithotripsy","ACTIVE_COMPARATOR","e.g. cutting or super high pressure balloons and\u002For ablative procedures",[19],"Device: Standard non-IVL methods",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DEVICE","Intravascular lithotripsy (IVL)","Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Standard non-IVL methods","Standard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures",[15],[31],{"name":32,"affiliation":33,"role":34},"Adnan Kastrati, MD","Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen","STUDY_CHAIR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Salvatore Cassese, MD, PHD","CONTACT","+49891218","2764","cassese@dhm.mhn.de",{"name":43,"role":38,"phone":39,"phoneExt":44,"email":45},"Thorsten Kessler, MD","2786","thorsten.kessler@tum.de",[47,61,78,93,102,113,128,143,158,172,187,202,213,228,242,258,273,288,303,313,329,346],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":11},"Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie","ACTIVE_NOT_RECRUITING","Heidelberg","Baden-Wurttemberg","69120","Germany","DE",{"type":56,"coordinates":57},"Point",[58,59],8.69079,49.40768,{"lat":59,"lon":58},{"facility":62,"status":63,"city":64,"state":51,"zip":65,"country":53,"countryCode":54,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin","RECRUITING","Mannheim","68167",{"type":56,"coordinates":67},[68,69],8.46694,49.4891,{"lat":69,"lon":68},[72,76],{"name":73,"role":38,"phone":74,"phoneExt":11,"email":75},"Ibrahim Akin, Prof. Dr. med.","+49-621-383 2512","ibrahim.akin@umm.de",{"name":73,"role":77,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":79,"status":63,"city":80,"state":51,"zip":81,"country":53,"countryCode":54,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)","Singen","78224",{"type":56,"coordinates":83},[84,85],8.8403,47.75935,{"lat":85,"lon":84},[88,92],{"name":89,"role":38,"phone":90,"phoneExt":11,"email":91},"Marc Kollum, PD Dr. med.","+49-7731-89 2600","marc.kollum@glkn.de",{"name":89,"role":77,"phone":11,"phoneExt":11,"email":11},{"facility":94,"status":49,"city":95,"state":51,"zip":96,"country":53,"countryCode":54,"cosmosGeoPoint":97,"geoPoint":101,"contacts":11},"Cardiologikum Herzklinik Ulm MVZ","Ulm","89077",{"type":56,"coordinates":98},[99,100],9.99155,48.39841,{"lat":100,"lon":99},{"facility":103,"status":63,"city":95,"state":51,"zip":104,"country":53,"countryCode":54,"cosmosGeoPoint":105,"geoPoint":107,"contacts":108},"Universitätsklinikum Ulm","89081",{"type":56,"coordinates":106},[99,100],{"lat":100,"lon":99},[109],{"name":110,"role":38,"phone":111,"phoneExt":11,"email":112},"Wolfgang Rottbauer, Prof. Dr. med.","+49 731 500 45001","sekretariat.rottbauer@uniklinik- ulm.de",{"facility":114,"status":63,"city":115,"state":116,"zip":117,"country":53,"countryCode":54,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Universitätsklinikum Augsburg A.ö.R.","Augsburg","Bavaria","86156",{"type":56,"coordinates":119},[120,121],10.89851,48.37154,{"lat":121,"lon":120},[124],{"name":125,"role":38,"phone":126,"phoneExt":11,"email":127},"Dario Bongiovanni, Prof. Dr. med., PhD","+49 821 400 165 824","dario.bongiovanni@uk-augsburg.de",{"facility":129,"status":63,"city":130,"state":116,"zip":131,"country":53,"countryCode":54,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie","Dachau","85221",{"type":56,"coordinates":133},[134,135],11.43402,48.26,{"lat":135,"lon":134},[138,142],{"name":139,"role":38,"phone":140,"phoneExt":11,"email":141},"Bernhard Witzenbichler, PD Dr. med.","+49-8131-76 228","bernhard.witzenbichler@helios-gesundheit.de",{"name":139,"role":77,"phone":11,"phoneExt":11,"email":11},{"facility":144,"status":63,"city":145,"state":116,"zip":146,"country":53,"countryCode":54,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Klinikum Landkreis Erding","Erding","85435",{"type":56,"coordinates":148},[149,150],11.90686,48.30603,{"lat":150,"lon":149},[153,157],{"name":154,"role":38,"phone":155,"phoneExt":11,"email":156},"Lorenz Bott-Flügel, PD Dr. med.","+49 8122 591760","lorenz.bott-fluegel@klinikum-erding.de",{"name":154,"role":77,"phone":11,"phoneExt":11,"email":11},{"facility":159,"status":63,"city":160,"state":116,"zip":161,"country":53,"countryCode":54,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Klinikum Ingolstadt","Ingolstadt","85049",{"type":56,"coordinates":163},[164,165],11.42372,48.76508,{"lat":165,"lon":164},[168],{"name":169,"role":38,"phone":170,"phoneExt":11,"email":171},"Blerim Luani, PD Dr. med.","+49 841 8 80-21 00","blerim.luani@klinikum-ingolstadt.de",{"facility":173,"status":63,"city":174,"state":116,"zip":175,"country":53,"countryCode":54,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Deutsches Herzzentrum München","Munich","80636",{"type":56,"coordinates":177},[178,179],11.57549,48.13743,{"lat":179,"lon":178},[182,185],{"name":183,"role":38,"phone":184,"phoneExt":40,"email":41},"Salvatore Cassese, PD, PHD","+49 89 1218",{"name":186,"role":77,"phone":11,"phoneExt":11,"email":11},"Salvatore Cassese, MD, PDH",{"facility":188,"status":189,"city":190,"state":116,"zip":191,"country":53,"countryCode":54,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Klinikum der Ludwig-Maximilians-Universität München","NOT_YET_RECRUITING","München","81337",{"type":56,"coordinates":193},[194,195],13.46314,48.69668,{"lat":195,"lon":194},[198],{"name":199,"role":38,"phone":200,"phoneExt":11,"email":201},"Konstantinos Rizas, Prof. Dr. med.","+49 89 4400 73169","konstantinos.rizas@med.uni-muenchen.de",{"facility":203,"status":63,"city":190,"state":116,"zip":204,"country":53,"countryCode":54,"cosmosGeoPoint":205,"geoPoint":207,"contacts":208},"Augustinum Klinik München","81375",{"type":56,"coordinates":206},[194,195],{"lat":195,"lon":194},[209],{"name":210,"role":38,"phone":211,"phoneExt":11,"email":212},"Oliver Husser, Prof. Dr. med.","+49 89 7097 1154","oliver.husser@med.augustinum.de",{"facility":214,"status":63,"city":215,"state":216,"zip":217,"country":53,"countryCode":54,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Universitäres Herz- und Gefäßzentrum","Hamburg","Free and Hanseatic City of Hamburg","20246",{"type":56,"coordinates":219},[220,221],9.99302,53.55073,{"lat":221,"lon":220},[224],{"name":225,"role":38,"phone":226,"phoneExt":11,"email":227},"Fabian Brunner, PD Dr. med.","+49 40 7410-53979","fa.brunner@uke.de",{"facility":229,"status":63,"city":230,"state":53,"zip":231,"country":53,"countryCode":54,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Krankenhaus Landshut-Achdorf, LAKUMED Kliniken","Landshut","84036",{"type":56,"coordinates":233},[234,235],12.16179,48.52961,{"lat":235,"lon":234},[238],{"name":239,"role":38,"phone":240,"phoneExt":11,"email":241},"Julinda Mehilli, Prof. Dr. med.","+49 871 404 2780","julinda.mehilli@lakumed.de",{"facility":243,"status":63,"city":244,"state":245,"zip":246,"country":53,"countryCode":54,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung","Rotenburg an der Fulda","Hesse","36199",{"type":56,"coordinates":248},[249,250],9.72838,50.99556,{"lat":250,"lon":249},[253,257],{"name":254,"role":38,"phone":255,"phoneExt":11,"email":256},"Marcus Franz, Prof. Dr. med.","+49-6623-88 60 10","M.Franz@hkz-rotenburg.de",{"name":254,"role":77,"phone":11,"phoneExt":11,"email":11},{"facility":259,"status":63,"city":260,"state":261,"zip":262,"country":53,"countryCode":54,"cosmosGeoPoint":263,"geoPoint":267,"contacts":268},"Herz- und Diabeteszentrum Nordrhein-Westfalen","Bad Oeynhausen","North Rhine-Westphalia","32545",{"type":56,"coordinates":264},[265,266],8.80365,52.20699,{"lat":266,"lon":265},[269],{"name":270,"role":38,"phone":271,"phoneExt":11,"email":272},"Mohamed Ayoub, Dr. med.","+49 5731 97-1276","mayoub@hdz-nrw.de",{"facility":274,"status":63,"city":275,"state":261,"zip":276,"country":53,"countryCode":54,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum","Essen","45138",{"type":56,"coordinates":278},[279,280],7.01228,51.45657,{"lat":280,"lon":279},[283,287],{"name":284,"role":38,"phone":285,"phoneExt":11,"email":286},"Tobias Weinreich, Dr. med.","+49-201-897 3200","t.weinreich@contilia.de",{"name":284,"role":77,"phone":11,"phoneExt":11,"email":11},{"facility":289,"status":63,"city":290,"state":291,"zip":292,"country":53,"countryCode":54,"cosmosGeoPoint":293,"geoPoint":297,"contacts":298},"Krankenhaus Barmherzige Brüder Trier","Trier","Rhineland-Palatinate","54292",{"type":56,"coordinates":294},[295,296],6.63935,49.75565,{"lat":296,"lon":295},[299],{"name":300,"role":38,"phone":301,"phoneExt":11,"email":302},"Nikos Werner, Prof. Dr. med.","+49 651 208 2784","n.werner@bbtgruppe.de",{"facility":304,"status":49,"city":305,"state":306,"zip":307,"country":53,"countryCode":54,"cosmosGeoPoint":308,"geoPoint":312,"contacts":11},"Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden","Dresden","Saxony","01307",{"type":56,"coordinates":309},[310,311],13.73832,51.05089,{"lat":311,"lon":310},{"facility":314,"status":63,"city":315,"state":316,"zip":317,"country":53,"countryCode":54,"cosmosGeoPoint":318,"geoPoint":322,"contacts":323},"Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin","Bad Oldesloe","Schleswig-Holstein","23843",{"type":56,"coordinates":319},[320,321],10.37417,53.81167,{"lat":321,"lon":320},[324,328],{"name":325,"role":38,"phone":326,"phoneExt":11,"email":327},"Ralph Tölg, PD Dr. med.","+49-4531-682405","r.toelg@asklepios.com",{"name":325,"role":77,"phone":11,"phoneExt":11,"email":11},{"facility":330,"status":63,"city":331,"state":332,"zip":333,"country":53,"countryCode":54,"cosmosGeoPoint":334,"geoPoint":338,"contacts":339},"Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité","Berlin","State of Berlin","10117",{"type":56,"coordinates":335},[336,337],13.41053,52.52437,{"lat":337,"lon":336},[340,344],{"name":341,"role":38,"phone":342,"phoneExt":11,"email":343},"Damaris Praeger, Dr. med.","+49 30 450 513 359","Damaris.praeger@dhzc-charite.de",{"name":345,"role":77,"phone":11,"phoneExt":11,"email":11},"Anna Brand, PD Dr. med.",{"facility":347,"status":63,"city":331,"state":332,"zip":348,"country":53,"countryCode":54,"cosmosGeoPoint":349,"geoPoint":351,"contacts":352},"BG Klinikum Unfallkrankenhaus Berlin gGmbH","12683",{"type":56,"coordinates":350},[336,337],{"lat":337,"lon":336},[353],{"name":354,"role":38,"phone":355,"phoneExt":11,"email":356},"Johannes Beil, Dr. med.","+49 30 5681 - 3641","Johannes.beil@ukb.de",{"type":358,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[360,362,365,367],{"name":361,"class":6},"Gemeinsamer Bundesaussschuss",{"name":363,"class":364},"EvidentIQ Germany GmbH","UNKNOWN",{"name":366,"class":364},"Monitoring Services GmbH",{"name":368,"class":6},"Technical University of Munich","100544458","intracoronary-stenting-and-additional-results-achieved-by-shockwave-coronary-lithotripsy-100544458",false,"NCT06369142","Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy","Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy: A Randomized, Multicenter Study About the Additional Benefit of Coronary Lithotripsy","ISAR-WAVE","Inclusion Criteria:\n\n1. age ≥18 years and able to give informed consent\n2. written informed consent to participate in the clinical trial\n3. typical angina pectoris or non-invasive evidence of relevant ischemia under optimal drug therapy\n4. angiographic evidence of coronary artery disease\n5. de novo lesion in a native coronary artery\n6. target vessel diameter 2.5-4 mm\n7. severe calcification of the target lesion (angiographic grade 3)\n\nExclusion Criteria:\n\n1. myocardial infarction \\\u003C1 week\n2. thrombus in the target vessel\n3. life expectancy due to other disease \\\u003C1 year\n4. simultaneous participation in a clinical trial with medical devices or medicinal products that has not yet been completed\n5. pregnancy (current, suspected, planned) or positive pregnancy test","ALL","18 Years",{"count":380,"type":381},666,"ESTIMATED","INTERVENTIONAL",[384],"NA","The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses.",[387],"Coronary Artery Disease",[387,389,390,391,392],"Calcified lesion","Percutaneous Coronary Intervention","Stent","Intravascular Lithotripsy","2026-01-05",{"date":395,"type":396},"2026-01-06","ACTUAL",{"date":398,"type":396},"2024-07-01",{"date":400,"type":381},"2027-07-31",{"name":5,"class":6},22]