[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thoracic-aortic-aneurysm-without-rupture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thoracic-aortic-aneurysm-without-rupture":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":20,"type":21},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.",[25,26,27],"Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture","Abdominal Aortic Aneurysm Without Rupture","Thoracic Aortic Aneurysm Without Rupture","RECRUITING","2025-05-19",{"date":31,"type":32},"2025-05-23","ACTUAL",{"date":29,"type":32},{"date":35,"type":21},"2027-05-30",{"name":37,"class":38},"Rede Optimus Hospitalar SA","NETWORK",5]