[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594227":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":28,"locations":37,"responsibleParty":68,"collaborators":19,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":19,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":19,"enrollmentInfo":79,"targetDuration":19,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":40,"whyStopped":19,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"C. R. Bard","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Rotarex(TM) Rotational Excisional Atherectomy System","OTHER","Subjects treated with RotarexTM Rotational Excisional Atherectomy System",[13],"Device: Rotarex(TM) Rotational Excisional Atherectomy System",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System",[9],null,[21,25],{"name":22,"affiliation":23,"role":24},"Prakash Krishnan, MD, FACC","The Icahn School of Medicine, The Mount Sinai Health System","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Todd L Berland, MD, FACS","NYU Langone Health",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":19,"email":33},"Adrija Sharma, PhD","CONTACT","19014578360","adrija.sharma@bd.com",{"name":35,"role":31,"phone":19,"phoneExt":19,"email":36},"Talar Saber","talar.saber@bd.com",[38,56],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Radiology and Imaging Specialists","RECRUITING","Lakeland","Florida","33805","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-81.9498,28.03947,{"lat":50,"lon":49},[53],{"name":54,"role":31,"phone":55,"phoneExt":19,"email":33},"Adrija Sharma","901-457-8360",{"facility":57,"status":40,"city":58,"state":59,"zip":60,"country":44,"countryCode":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Vital Heart and Vein","Humble","Texas","77338",{"type":47,"coordinates":62},[63,64],-95.26216,29.99883,{"lat":64,"lon":63},[67],{"name":54,"role":31,"phone":55,"phoneExt":19,"email":33},{"type":69,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100594227","real-world-registry-of-the-rotarextm-rotational-excisional-atherectomy-system-xtract-registry-100594227",false,"NCT07016698","Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)","A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)","Inclusion Criteria:\n\n1. Subject or legally authorized representative provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the IRB for the site.\n2. Subject is ≥22 years old at the time of signing the informed consent.\n3. Subject must have a lesion(s) in their infra-inguinal peripheral arteries that can be treated with the RotarexTM Rotational Excisional Atherectomy System according to Instructions For Use (IFU).\n4. Rutherford 2-5 for chronic limb ischemia and Rutherford I to IIb for acute limb ischemia.\n5. Target lesion can be crossed intra-luminally by guidewire.\n6. At least one patent native outflow artery to the foot, free from significant stenosis(≥50% stenosis as confirmed by angiography) (ChLI Cohort only, not applicable to ALI Cohort).\n\nExclusion Criteria:\n\n1. Subject is unable or unwilling to comply with follow-up procedures and visits.\n2. Subject has a target lesion in a vessel with less than 3 mm in diameter.\n3. Subject is participating in another device or drug clinical trial that interferes with this protocol and confounds results.\n4. Treatment plan includes use of a thrombectomy and\u002For atherectomy device other than RotarexTM Rotational Excisional Atherectomy System.\n5. Life expectancy is below 1 year.\n6. Pregnant, planning to become pregnant during the course of the study or nursing a child.","ALL","22 Years",{"count":80,"type":81},600,"ESTIMATED","INTERVENTIONAL",[84],"NA","The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.",[87],"Peripheral Arterial Disease(PAD)",[89,90],"Rotarex","PAD","2025-12-12",{"date":93,"type":94},"2025-12-17","ACTUAL",{"date":96,"type":94},"2025-09-29",{"date":98,"type":81},"2029-05-31",{"name":5,"class":6},2]