[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549451":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":31,"locations":40,"responsibleParty":66,"collaborators":25,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":25,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Cagent Vascular LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Serrantor","ACTIVE_COMPARATOR","Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon",[13],"Device: Serranator PTA Serration Catheter",{"label":15,"type":10,"description":16,"interventionNames":17},"PTA","Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon.",[18],"Drug: PTA (Standard of Care)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Serranator PTA Serration Catheter","The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DRUG","PTA (Standard of Care)","A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Feeny","CONTACT","4197878496","kjclinconsulting@gmail.com",{"name":38,"role":34,"phone":25,"phoneExt":25,"email":39},"Wittwer","twittwer@mededge.io",[41,57],{"facility":42,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Columbia University","RECRUITING","New York","10032","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-74.00597,40.71427,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":25,"phoneExt":25,"email":25},"K Dalton",{"facility":58,"status":43,"city":44,"state":44,"zip":59,"country":46,"countryCode":47,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"Weill Cornell Medical","10065",{"type":49,"coordinates":61},[51,52],{"lat":52,"lon":51},[64],{"name":65,"role":34,"phone":25,"phoneExt":25,"email":25},"R Chu",{"type":67,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100549451","serrantor-oct-study-100549451",false,"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","ALL","19 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"NA","TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.",[85],"Critical Limb Ischemia","2025-05-14",{"date":88,"type":89},"2025-05-18","ACTUAL",{"date":91,"type":89},"2024-10-31",{"date":93,"type":79},"2025-06-01",{"name":5,"class":6},2]