[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07016698":3,"trial-entities:NCT07016698":99,"trial-summary:NCT07016698":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":15,"eligibility_criteria":49,"std_ages":53,"locations":56,"central_contacts":82,"overall_officials":89,"references":97,"see_also_links":98},"NCT07016698","BDPI-25-001","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)","RECRUITING","2029-05-31","2025-12","2025-12-17","2025-09-29","C. R. Bard","INDUSTRY",false,"The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.","The study will recruit approximately 600 subjects treated for PAD.",[19],"Peripheral Arterial Disease(PAD)",[21,22],"Rotarex","PAD","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},600,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Rotarex(TM) Rotational Excisional Atherectomy System","Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System",[33],[37,41],{"measure":38,"description":39,"timeFrame":40},"Procedural Success","Procedural Success defined as the rate of successful revascularization of target lesion (residual stenosis\u002Fthrombus ≤30%) following index procedure.","Immediate Post Index Procedure",{"measure":42,"description":43,"timeFrame":44},"Freedom from major complications","Freedom from composite of device and\u002For procedure related perioperative (≤30 day) death, unplanned target limb major amputation (above the ankle), and clinically driven target lesion revascularization (CD-TLR) at 30 days post index procedure","30 days post index procedure",[],"ALL","22 Years",null,{"inclusion":50,"exclusion":51,"raw_text":52},[],[],"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.",[54,55],"ADULT","OLDER_ADULT",[57,72],{"facility":58,"status":8,"city":59,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":69},"Radiology and Imaging Specialists","Lakeland","Florida","33805","United States",[64],{"name":65,"role":66,"phone":67,"email":68},"Adrija Sharma","CONTACT","901-457-8360","adrija.sharma@bd.com",{"lat":70,"lon":71},28.03947,-81.9498,{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":62,"contacts":77,"geoPoint":79},"Vital Heart and Vein","Humble","Texas","77338",[78],{"name":65,"role":66,"phone":67,"email":68},{"lat":80,"lon":81},29.99883,-95.26216,[83,86],{"name":84,"role":66,"phone":85,"email":68},"Adrija Sharma, PhD","19014578360",{"name":87,"role":66,"email":88},"Talar Saber","talar.saber@bd.com",[90,94],{"name":91,"affiliation":92,"role":93},"Prakash Krishnan, MD, FACC","The Icahn School of Medicine, The Mount Sinai Health System","PRINCIPAL_INVESTIGATOR",{"name":95,"affiliation":96,"role":93},"Todd L Berland, MD, FACS","NYU Langone Health",[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Peripheral Artery Disease",[],{"nct_id":4,"found":104,"summary":105,"prompt_version":115},true,{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is a single-arm study, meaning all participants receive the same treatment. It plans to enroll approximately 600 subjects.","completed","XTRACT Registry for Rotarex™ System in PAD","This study, called the XTRACT Registry, is looking at how well the Rotarex™ Rotational Excisional Atherectomy System works for people with Peripheral Arterial Disease (PAD). PAD is a condition where narrowed arteries reduce blood flow to your limbs. The study aims to enroll about 600 participants. To join, you need to be at least 22 years old and have PAD in your leg arteries that can be treated with the Rotarex™ system. Researchers will look at how successful the procedure is right away and if there are any major problems within 30 days after the procedure. The current recruitment status is unclear.","Researchers will check for major complications up to 30 days after your procedure.",102,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]