[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639744":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":24,"responsibleParty":35,"collaborators":37,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":24,"enrollmentInfo":56,"targetDuration":24,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":24,"overallStatus":65,"whyStopped":24,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":24},{"fullName":5,"class":6},"Cagent Vascular LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Above-the-Knee","EXPERIMENTAL","For blockages in the legs that occur above the knee.",[13],"Device: Serranator Sonic Intravascular Lithotripsy (IVL) System",{"label":15,"type":10,"description":16,"interventionNames":17},"Below-the-Knee","For blockages in the legs that occur below the knee.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Serranator Sonic Intravascular Lithotripsy (IVL) System","Serration remodeling balloon angioplasty with Intravascular Lithotripsy of the superficial femoral and popliteal arteries for Cohort A: Above-the-Knee; treatment of the infrapopliteal and inframalleolar arteries for Cohort B: Below-the-Knee.",[9,15],null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Alexis Shewfelt","CONTACT","650-208-6743","ashewfelt33@cagentvascular.com",{"name":32,"role":28,"phone":33,"phoneExt":24,"email":34},"Jennifer Meyers Sullivan","219-730-9402","jsullivan64@cagentvascular.com",{"type":36,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[38,40,43],{"name":39,"class":6},"Clinical Accelerator",{"name":41,"class":42},"Australian Healthcare Solutions","UNKNOWN",{"name":44,"class":45},"Yale Cardiovascular Research Group","OTHER","100639744","revascularization-with-modification-using-definitive-ivl-and-serration-remodeling-for-optimal-lumen-100639744",false,"NCT07575568","Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen","REMODEL I: Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen","REMODEL I","\\*Inclusion Criteria for Cohort A: ATK arm of the study:\n\nClinical:\n\n* Subject is ≥ 18 years of age\n* Target limb is Rutherford Clinical Category 2, 3 or 4\n* Resting ABI of ≤0.90, or TBI ≤0.70 of the target limb\n\nAngiographic:\n\n* Subject must have a de novo target lesion in a native superficial femoral artery (SFA) or popliteal artery\n* Reference vessel diameter (RVD) between 4.0 and 8.0mm\n* Target lesion must have a diameter stenosis of ≥70%\n* Lesion calcification is at least moderate\n* Total planned target lesion length must be ≤150mm\n* Chronic total occlusion lesion length is ≤100mm\n* Subject has at least one patent tibial vessel on the target limb with runoff to the foot\n\n  * Exclusion Criteria for Cohort A: ATK arm of the study:\n\nClinical:\n\n* Rutherford Clinical Categories 0, 1, 5 and 6\n* Subject with known pregnancy or is nursing\n* Subject has acute or chronic renal disease, defined as serum creatinine of \\>2.5 mg\u002FdL or \\>220 µmol\u002FL or on dialysis\n\nAngiographic:\n\n* Target lesions \\>150mm by visual estimation\n* Chronic total occlusions \\> 100mm by visual estimation\n* No or mild calcium present in the target lesion\n\n  * Inclusion Criteria for Cohort B: BTK arm of the study:\n\nClinical:\n\n* Age of subject is ≥18\n* Rutherford Clinical Category 2 - 5 (with tissue loss limited to the digits and no evidence of infection)\n\nAngiographic:\n\n* Single or two target lesion(s) located in a de novo artery distal to the trifurcation vessels\n* Target vessel reference diameter is between 2.5mm and 4.0 mm\n* Target lesion with diameter stenosis ≥50%\n* Target lesion is ≤150mm in length\n* Subject has at least one patent tibial vessel (\\>50%) with run-off to the foot.\n* Calcification is at least moderate\n\n  * Exclusion Criteria for Cohort B: BTK arm of the study:\n\nClinical:\n\n* Rutherford Clinical Category 0,1 or 6\n* Gangrene of the lower extremity\n* Patient is pregnant or nursing\n\nAngiographic:\n\n* Target lesion is within only lower extremity vessel with \\\u003C 50% stenosis\n* Target lesion length exceeds 150mm\n* Patient has chronic total occlusion of target lesion","ALL","18 Years",{"count":57,"type":58},30,"ESTIMATED","INTERVENTIONAL",[61],"NA","The objective of this first-in-human study is to assess the safety and effectiveness of the Serranator Sonic Intravascular Lithotripsy (IVL) System™ for the treatment of peripheral artery disease.",[64],"Peripheral Artery Disease","NOT_YET_RECRUITING","2026-05-04",{"date":68,"type":69},"2026-05-08","ACTUAL",{"date":71,"type":58},"2026-05",{"date":73,"type":58},"2027-09",{"name":5,"class":6}]