[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509704":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":60,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":82,"studyType":83,"phases":10,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Regional Cardiology Center, The Copper Health Centre (MCZ),","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"S-IVL Intervention",null,"Patients with the presence of a highly calcified, resistant lesion or a significantly under-expanded, previously implanted stent (regardless of the time of implantation) were part of the study cohort. The lesion was defined as resistant after an unsuccessful high-pressure NC balloon inflation (at least 20% under-expansion; whit at least 16 atm.). The decision regarding initial lesion preparation was left to the operators' dissertation and did not imply a recruitment process.\n\nThere were no angiographic exclusion criteria regarding lesion anatomy regarding the length, tortuosity, severity, or prior stent placement. Operators supported by angiography assessment with optional intravascular imagining (IVUS\u002FOCT) determined the size of the S-IVL catheter and an appropriate number of pulses for optimal vessel preparation or management of an under-expanded coronary stent.",[13],"Device: PCI with support of Shockwave Intravascular Lithotripsy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","PCI with support of Shockwave Intravascular Lithotripsy","Coronary artery angioplasty of the primary lesion or optimization of the previously implanted stent with the support of Shockwave Intravascular Lithotripsy device",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Adrian Włodarczak, M.D; Ph. D; Assoc Prof.","CONTACT","+48768460300","wlodarczak.adrian@gmail.com",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Piotr Rola, M.D.; Ph.D.","+48767211446","piotr.rola@gmail.com",[31,48],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Department of Cardiology, Provincial Specialized Hospital in Legnica,","RECRUITING","Legnica","Lower Silesian Voivodeship","59-220","Poland","PL",{"type":40,"coordinates":41},"Point",[42,43],16.1619,51.21006,{"lat":43,"lon":42},[46],{"name":47,"role":23,"phone":28,"phoneExt":10,"email":29},"Piotr Rola, M.D; Ph.D.",{"facility":49,"status":33,"city":50,"state":35,"zip":51,"country":37,"countryCode":38,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Department of Cardiology, The Copper Health Centre (MCZ)","Lubin","59-300",{"type":40,"coordinates":53},[54,55],16.20149,51.40089,{"lat":55,"lon":54},[58],{"name":59,"role":23,"phone":24,"phoneExt":10,"email":25},"Adrian Włodarczak, M.D; Ph.D.Assoc Prof.",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Adrian Włodarczak","M.D.; Ph.D. Assoc Prof.",[65],{"name":66,"class":67},"Provincial Specialized Hospital in Legnica","UNKNOWN","100509704","the-lower-silesia-shockwave-registry-100509704",false,"NCT05916898","The Lower Silesia Shockwave Registry","Evaluation of the Safety and Efficiency of ShockWave Intravascular Lithotripsy (S-IVL) in Coronary Artery Diseases. The Lower Silesia Shockwave Registry (LSSR)","LSSR","Inclusion Criteria:\n\n* The presence of moderately to severely calcified lesions.\n* The presence of significant under-expansion (greater than 20% of the diameter) of the previously implanted stent.\n* Initial failure of the lesion preparation with either the NC balloon catheter or the atherectomy device.\n\nExclusion Criteria:\n\n* Lack of patient consent\n* Target vessel dissection type 3 or higher according to spontaneous coronary artery dissection (SCAD) classification\n* Target vessel perforation due to previous unsuccessful lesion preparation\n* Pregnancy","ALL","18 Years","99 Years",{"count":80,"type":81},400,"ESTIMATED","5 Years","OBSERVATIONAL","Lower Silesia Shockwave Registry (LSSR), is a observational registry collecting all consecutive cases of percutaneous coronary intervention (PCI) performed with the support of shockwave intravascular lithotripsy in two cooperating cardiac centers (Department of Cardiology, The Copper Health Centre, Lubin Poland, and Department of Cardiology, Provincial Specialized Hospital in Legnica, Poland).",[86,87],"Safety Issues","Efficacy, Self",[89,90,91,92,93,94,95],"Percutaneous coronary interventions","Calcified Lesion","Shockwave intravascular lithotripsy","Stent under-expansion","Coronary artery diseases","lesion preparation","stent optimalization","2023-06-21",{"date":98,"type":99},"2023-06-23","ACTUAL",{"date":101,"type":99},"2022-05-01",{"date":103,"type":81},"2027-05-01",{"name":5,"class":6},2]