[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541672":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":29,"locations":39,"responsibleParty":114,"collaborators":116,"id":120,"slug":10,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":121,"sex":127,"minAge":128,"maxAge":10,"enrollmentInfo":129,"targetDuration":10,"studyType":132,"phases":10,"briefSummary":133,"conditions":134,"keywords":10,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"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",[40,51,66,82,97],{"facility":27,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":10,"geoPoint":10,"contacts":46},"RECRUITING","Münich","Bavaria","80337","Germany",[47],{"name":48,"role":32,"phone":49,"phoneExt":10,"email":50},"Prof. Nikolaos Tsilimparis","+49 (0)89 4400 73505","Nikolaos.Tsilimparis@med.uni-muenchen.de",{"facility":52,"status":41,"city":53,"state":43,"zip":54,"country":45,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Department of Vascular Surgery, Klinikum Nürnberg Campus Süd","Nuremberg","90471",{"type":56,"coordinates":57},"Point",[58,59],11.07752,49.45421,{"lat":59,"lon":58},[62],{"name":63,"role":32,"phone":64,"phoneExt":10,"email":65},"Prof. Eric Verhoeven","+49 (0) 911 398-2651","eric.verhoeven@klinikum-nuernberg.de",{"facility":67,"status":41,"city":68,"state":69,"zip":70,"country":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM","Genoa","Liguria","16132","Italy",{"type":56,"coordinates":73},[74,75],8.94439,44.40478,{"lat":75,"lon":74},[78],{"name":79,"role":32,"phone":80,"phoneExt":10,"email":81},"Prof. Giovanni Pratesi","+39 010 555 2424","giovanni.pratesi@hsanmartino.it",{"facility":83,"status":41,"city":84,"state":85,"zip":86,"country":71,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Azienda Ospedaliera Universitaria Integrata di Verona","Verona","Veneto","37126",{"type":56,"coordinates":88},[89,90],10.9938,45.43854,{"lat":90,"lon":89},[93],{"name":94,"role":32,"phone":95,"phoneExt":10,"email":96},"Prof. Gian Franco Veraldi","+39-045-812-2505","gianfranco.veraldi@aovr.veneto.it",{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Inselspital, University Hospital Bern, Heart Vascular Center","NOT_YET_RECRUITING","Bern","Canton Bern","CH-3010","Switzerland",{"type":56,"coordinates":105},[106,107],7.44744,46.94809,{"lat":107,"lon":106},[110],{"name":111,"role":32,"phone":112,"phoneExt":10,"email":113},"Prof. Dr. Drosos Kotelis","+41(0)031 6325000","drosos.kotelis@insel.ch",{"type":115,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[117],{"name":118,"class":119},"Shockwave Medical, Inc.","INDUSTRY","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":130,"type":131},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.",[135,136,137],"Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture","Abdominal Aortic Aneurysm Without Rupture","Thoracic Aortic Aneurysm Without Rupture","2025-05-19",{"date":140,"type":141},"2025-05-23","ACTUAL",{"date":138,"type":141},{"date":144,"type":131},"2027-05-30",{"name":5,"class":6},5]