[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cagent Vascular LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,67],{"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":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"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":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Peripheral Artery Disease","NOT_YET_RECRUITING","2026-05-04",{"date":31,"type":32},"2026-05-08","ACTUAL",{"date":34,"type":21},"2026-05",{"date":36,"type":21},"2027-09",{"name":38,"class":39},"Cagent Vascular LLC","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":50,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100568927","serranator-point-force-registry-100568927","NCT06687590","Serranator POINT FORCE Registry","POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter","POINT FORCE","Inclusion Criteria:\n\n* Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae.\n* Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb.\n* Age of subject is \\> 18.\n* Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form.\n\nExclusion Criteria:\n\n* Subjects with any medical condition that would make him\u002Fher an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion.\n* Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.",{"count":49,"type":21},500,"1 Day","OBSERVATIONAL","The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.\n\nThe data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.",[54,55,56],"Peripheral Artery Disease (PAD)","Dysfunctional AV Fistula","Dysfunctional AV Graft","RECRUITING","2026-05-01",{"date":60,"type":32},"2026-05-07",{"date":62,"type":32},"2025-01-22",{"date":64,"type":21},"2026-08-31",{"name":38,"class":39},19,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":74,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100549451","serrantor-oct-study-100549451","NCT06434194","Serrantor OCT Study","Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)","Inclusion Criteria:\n\n* Rutherford clinical category 4-6 of the target limb\n* Age of subjects is \\>18 years old\n* Patients has given informed consent to participate in this study\n\nExclusion Criteria:\n\n* De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion\n* Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.\n* Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.\n* Lesion length less than 220 mm","19 Years",{"count":76,"type":21},60,[24],"TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.",[80],"Critical Limb Ischemia","2025-05-14",{"date":83,"type":32},"2025-05-18",{"date":85,"type":32},"2024-10-31",{"date":87,"type":21},"2025-06-01",{"name":38,"class":39},2,""]