[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541672":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":29,"locations":39,"responsibleParty":117,"collaborators":119,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":10,"enrollmentInfo":133,"targetDuration":10,"studyType":136,"phases":10,"briefSummary":137,"conditions":138,"keywords":10,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Rede Optimus Hospitalar SA","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"complex endovascular thoracic aortic repair",null,"Patients submitted to complex endovascular thoracic aortic repair with hostile iliac access vessels using the Shockwave device to gain access.",[13],"Device: Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+","Cracking-not-debulking technique (SHOCKWAVE IVL)",[9],[21,25],{"name":22,"affiliation":23,"role":24},"Marc Bosiers, Dr.","Rede Optimus Hospitalar AG","STUDY_DIRECTOR",{"name":26,"affiliation":27,"role":28},"Nikolaos Tsilimparis, Prof.","Department of Vascular Surgery, LMU Hospital Munich","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Phina Muna, Dr.","CONTACT","+49 157 80 58 5869","phina.muna@redeoptimus.com",{"name":36,"role":32,"phone":37,"phoneExt":10,"email":38},"Annelena Held-Wehmöller, Dr.","+49 157 85128140","annelena.held@redeoptimus.com",[40,52,67,84,99],{"facility":27,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":10,"geoPoint":10,"contacts":47},"RECRUITING","Münich","Bavaria","80337","Germany","DE",[48],{"name":49,"role":32,"phone":50,"phoneExt":10,"email":51},"Prof. Nikolaos Tsilimparis","+49 (0)89 4400 73505","Nikolaos.Tsilimparis@med.uni-muenchen.de",{"facility":53,"status":41,"city":54,"state":43,"zip":55,"country":45,"countryCode":46,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Department of Vascular Surgery, Klinikum Nürnberg Campus Süd","Nuremberg","90471",{"type":57,"coordinates":58},"Point",[59,60],11.07752,49.45421,{"lat":60,"lon":59},[63],{"name":64,"role":32,"phone":65,"phoneExt":10,"email":66},"Prof. Eric Verhoeven","+49 (0) 911 398-2651","eric.verhoeven@klinikum-nuernberg.de",{"facility":68,"status":41,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM","Genoa","Liguria","16132","Italy","IT",{"type":57,"coordinates":75},[76,77],8.94439,44.40478,{"lat":77,"lon":76},[80],{"name":81,"role":32,"phone":82,"phoneExt":10,"email":83},"Prof. Giovanni Pratesi","+39 010 555 2424","giovanni.pratesi@hsanmartino.it",{"facility":85,"status":41,"city":86,"state":87,"zip":88,"country":72,"countryCode":73,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Azienda Ospedaliera Universitaria Integrata di Verona","Verona","Veneto","37126",{"type":57,"coordinates":90},[91,92],10.9938,45.43854,{"lat":92,"lon":91},[95],{"name":96,"role":32,"phone":97,"phoneExt":10,"email":98},"Prof. Gian Franco Veraldi","+39-045-812-2505","gianfranco.veraldi@aovr.veneto.it",{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Inselspital, University Hospital Bern, Heart Vascular Center","NOT_YET_RECRUITING","Bern","Canton Bern","CH-3010","Switzerland","CH",{"type":57,"coordinates":108},[109,110],7.44744,46.94809,{"lat":110,"lon":109},[113],{"name":114,"role":32,"phone":115,"phoneExt":10,"email":116},"Prof. Dr. Drosos Kotelis","+41(0)031 6325000","drosos.kotelis@insel.ch",{"type":118,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[120],{"name":121,"class":122},"Shockwave Medical, Inc.","INDUSTRY","100541672","shockwaveperipheral-intravascular-lithotripsy-balloon-for-advanced-endovascular-aortic-repair-100541672",false,"NCT06332911","Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair","International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair","TEVAR","Inclusion Criteria:\n\n1. Patient (m\u002Ff) age ≥ 18 years at time of enrollment.\n2. Diagnosis of thoracic and\u002For thoraco-abdominal (Extent I-V) and juxta\u002Fpara-renal\u002Fshort-neck aneurysm requiring the implantation of a thoracic and\u002For thoraco-abdominal fenestrated\u002Fbranched aortic endograft with delivery system introducer sheath diameter equal or larger than 18 Fr (6 mm).\n3. Hostile iliac access was defined in the presence of:\n\n   * Heavily circumferential calcified iliac arteries\n   * Inner diameter ≤ 6 mm\n   * Severe stenosis (\\> 50%; \\> 2.5 m\u002Fs peak velocity; absence of triphasic duplex signal in ipsilateral common femoral artery)\n4. We will accept the following presentations of aneurysm:\n\n   * urgent cases,\n   * elective,\n   * symptomatic\n   * and fast growing.\n5. The repair was performed using Shockwave™ before the introduction of the main endograft. The iliac procedures can be accompanied by angioplasty and\u002For stent and stent-graft positioning.\n\nExclusion Criteria:\n\n1. Patients submitted to surgical conduit bypass.\n2. Not-severely calcified disease (absence of calcification).\n3. In-stent restenosis\u002Focclusion.\n4. Inability to cross with 0.014 guidewire.\n5. Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study.\n6. Pre-stented iliac access vessels at the level of Shockwave implementation.","ALL","18 Years",{"count":134,"type":135},30,"ESTIMATED","OBSERVATIONAL","Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.\n\nThe aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F\u002FBEVAR.",[139,140,141],"Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture","Abdominal Aortic Aneurysm Without Rupture","Thoracic Aortic Aneurysm Without Rupture","2025-05-19",{"date":144,"type":145},"2025-05-23","ACTUAL",{"date":142,"type":145},{"date":148,"type":135},"2027-05-30",{"name":5,"class":6},5]