[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506919":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":21,"locations":30,"responsibleParty":120,"collaborators":122,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":127,"sex":133,"minAge":134,"maxAge":7,"enrollmentInfo":135,"targetDuration":7,"studyType":138,"phases":7,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":33,"whyStopped":7,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"EndoCore Lab s.r.l.","OTHER",null,[9,13,17],{"name":10,"affiliation":11,"role":12},"Stefano Fazzini, MD","Fondazione PTV - Policlinico Tor Vergata","PRINCIPAL_INVESTIGATOR",{"name":14,"affiliation":15,"role":16},"Pierluigi Antignani, MD","Fondazione Italiana Vascolare (FIV)","STUDY_CHAIR",{"name":18,"affiliation":19,"role":20},"Gabriele Morselli, PharmD","EndoCore Lab","STUDY_DIRECTOR",[22,27],{"name":23,"role":24,"phone":25,"phoneExt":7,"email":26},"Daniela Ramaccini, PhD, PharmD","CONTACT","+39 3534390426","d.ramaccini@endocorelab.org",{"name":10,"role":24,"phone":28,"phoneExt":7,"email":29},"+39 06 20902 833","stefano.fazzini@uniroma2.it",[31,48,64,75,90,105],{"facility":32,"status":33,"city":34,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Azienda Ospedaliero Universitaria delle Marche","RECRUITING","Ancona","60126","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],13.5103,43.60717,{"lat":42,"lon":41},[45],{"name":46,"role":24,"phone":7,"phoneExt":7,"email":47},"Emanuele Gatta, MD","emanuele.gatta@ospedaliriuniti.marche.it",{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":36,"countryCode":37,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Sant'Orsola Hospital","NOT_YET_RECRUITING","Bologna","Emilia-Romagna","40138",{"type":39,"coordinates":55},[56,57],11.33875,44.49381,{"lat":57,"lon":56},[60],{"name":61,"role":24,"phone":62,"phoneExt":7,"email":63},"Mauro Gargiulo, Prof.","+39 051 344025","mauro.gargiulo2@unibo.it",{"facility":11,"status":33,"city":65,"state":66,"zip":67,"country":36,"countryCode":37,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Rome","Lazio","00133",{"type":39,"coordinates":69},[70,71],12.51133,41.89193,{"lat":71,"lon":70},[74],{"name":10,"role":24,"phone":28,"phoneExt":7,"email":29},{"facility":76,"status":50,"city":77,"state":78,"zip":79,"country":36,"countryCode":37,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Ospedale San Giovanni di Dio","Florence","Tuscany","50143",{"type":39,"coordinates":81},[82,83],11.24626,43.77925,{"lat":83,"lon":82},[86],{"name":87,"role":24,"phone":88,"phoneExt":7,"email":89},"Stefano Michelagnoli, MD","+39 055 6932675","stefano.michelagnoli@asf.toscana.it",{"facility":91,"status":50,"city":92,"state":93,"zip":94,"country":36,"countryCode":37,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Ospedale Santa Maria della Misericordia di Perugia","Perugia","Umbria","06156",{"type":39,"coordinates":96},[97,98],12.38878,43.1122,{"lat":98,"lon":97},[101],{"name":102,"role":24,"phone":103,"phoneExt":7,"email":104},"Massimo Lenti, MD","+39 0755786436","massimo.lenti@gmail.com",{"facility":106,"status":50,"city":107,"state":108,"zip":109,"country":36,"countryCode":37,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Azienda Ospedaliero-Universitaria di Padova","Padova","Veneto","35128",{"type":39,"coordinates":111},[112,113],11.77208,45.26618,{"lat":113,"lon":112},[116],{"name":117,"role":24,"phone":118,"phoneExt":7,"email":119},"Franco Grego, Prof.","+39 049 8212636","franco.grego@unipd.it",{"type":121,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[123],{"name":124,"class":6},"Fondazione Italiana Vascolare","100506919","use-of-shockwave-m5l6-ivl-catheter-intravascular-lithotripsy-in-hostile-and-calcified-iliac-access-100506919",false,"NCT05880641","Use of Shockwave M5+\u002FL6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access","No-profit, Pilot, Observational, Multicentric, Prospective Study on the Use of Shockwave M5+\u002FL6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access to Facilitate Aortic Endovascular Repair. SHOCK-ACCESS STUDY.","SHOCK-ACCESS","Inclusion Criteria:\n\n* Age ≥18 years old;\n* Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study;\n* Patient presenting with aortic disease indicated for endovascular treatment considered unfeasible based on severely calcified iliac access and outer diameter of the \"ideal\" aortic endograft at onset of the procedure (considering the main body and\u002For contralateral limb in case of iliac distal landing zone);\n* Patients presenting a ratio \\> 0.2 between outer diameter of the aortic stent graft delivery system (OD-SG) and minimum lumen diameter (MLD); decision concerning SG will be taken balancing the lower profile on the market and the better graft fit for patient's anatomy;\n* Patients presenting calcium grade 3 or 4 accordingly to 360° coronary classification (grade 1 = 0-90°, grade 2 = 90°-180°; grade 3 = 180°-270°; grade 4 = 270°-360°);\n* Patients presenting a lesion length \\> 20 mm, intended as the sum of all calcified iliac lesions between two endpoints, from the aortic bifurcation up to the proximal common femoral artery (CFA);\n* Patients eligible for treatment with Shockwave M5+ IVL device;\n* Patients presenting with aortic disease indicated for endovascular treatment associated or not to aorto-iliac occlusive disease (Rutherford classification score II - VI for chronic limb ischemia);\n* Patients compliant with the conduct of follow-up visits according to the timelines specified in the protocol.\n\nExclusion Criteria:\n\n* Bilateral Iliac Occlusion;\n* Urgent setting with presence of iliac thrombus (acute limb ischemia);\n* Any patient considered to be hemodynamically unstable at procedure onset;\n* Patients refusing treatment;\n* Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated;\n* Patients with a history of prior life-threatening contrast medium reaction;\n* Life expectancy of less than twelve months.","ALL","18 Years",{"count":136,"type":137},40,"ESTIMATED","OBSERVATIONAL","The study will evaluate, in a controlled setting, the efficacy and safety of the intravascular lithotripsy using Shockwave™ M5+\u002FL6 Peripheral Intravascular Lithotripsy Catheter to facilitate delivery of aortic large-bore devices in iliac calcified access.",[141,142,143],"Aortic Diseases","Aorto-Iliac Atherosclerosis","Peripheral Arterial Disease",[145,146,147],"Aortic Disease","Intravascular Lithotripsy","Hostile Access","2026-03-23",{"date":150,"type":151},"2026-03-25","ACTUAL",{"date":153,"type":151},"2023-06-26",{"date":155,"type":137},"2027-09",{"name":5,"class":6},6]