[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"EndoCore Lab s.r.l.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100537402","peripheral-extreme-revascularization-in-no-option-patiens-with-chronic-limb-threatening-ischemia-100537402",false,"NCT06277362","Peripheral Extreme Revascularization in \"No-option\" Patiens With Chronic Limb Threatening Ischemia","\"Arterial-Venous Reversal Flow in \"No-option\" Chronic Limb-threating Ischemia (CLTI) Patients\"","PiPER","Inclusion Criteria:\n\n* Age ≥18 years\n* Patient has signed an approved informed consent form\n* All patients, with non-revascularizable critical lower limb ischemia defined on the basis of 2 previous unsuccessful Percutaneous Transluminal Angioplasty (PTA) attempts or on severe Medial Artery Calcification (MAC)\u002FSmall Artery Disease (SAD) stage.\n* Patient with Critical Limb Ischaemia, Rutherford category, 5 (minor tissue loss) or 6 (major tissue loss) with active trophic lesions\n* Ejection Fraction \\> 30%\n\nExclusion Criteria:\n\n* Subject no able to perform the follow up or other factors making clinical follow-up difficult\n* Patients with critical ischaemia of the lower limbs revascularizable by bypass or angioplasty, critical ischaemia characterised by rest pain (Rutherford class ≤ 4)\n* Ejection Fraction \\\u003C 30%","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","OBSERVATIONAL","The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with \"no-option\" CLTI.",[25,26,27],"Peripheral Arterial Disease","Critical Limb-Threatening Ischemia","Diabetic Foot",[29,30,31],"PAD","DVA","CLTI","RECRUITING","2026-03-23",{"date":35,"type":36},"2026-03-24","ACTUAL",{"date":38,"type":36},"2020-01-31",{"date":40,"type":21},"2028-12",{"name":42,"class":43},"EndoCore Lab s.r.l.","OTHER",9,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100506919","use-of-shockwave-m5l6-ivl-catheter-intravascular-lithotripsy-in-hostile-and-calcified-iliac-access-100506919","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.",{"count":54,"type":21},40,"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.",[57,58,25],"Aortic Diseases","Aorto-Iliac Atherosclerosis",[60,61,62],"Aortic Disease","Intravascular Lithotripsy","Hostile Access",{"date":64,"type":36},"2026-03-25",{"date":66,"type":36},"2023-06-26",{"date":68,"type":21},"2027-09",{"name":42,"class":43},6,""]