[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100227622":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":50,"collaborators":53,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":79,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":10,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Carotid Artery Disease",null,"Patients undergoing carotid artery stenting for high grade carotid artery stenosis with or without neurologic symptoms and with or without a high risk for carotid endarterectomy.",[13],"Device: Carotid Artery Stent",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Carotid Artery Stent","Placement of a stent within the carotid artery",[9],[21],{"name":22,"affiliation":23,"role":24},"Brajesh K Lal, MD","University of Maryland","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Kimberlly A Castro-Roberts, MBA, CCRC","CONTACT","410-706-3941","knordstrom@som.umaryland.edu",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"University of Maryland - Administrative Center","RECRUITING","Baltimore","Maryland","21201","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-76.61219,39.29038,{"lat":44,"lon":43},[47,49],{"name":48,"role":28,"phone":29,"phoneExt":10,"email":30},"Kimberlly A Nordstrom, MBA, CCRC",{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"type":24,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Brajesh Lal","PI",[54,57,60,62,64],{"name":55,"class":56},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",{"name":58,"class":59},"Centers for Medicare and Medicaid Services","FED",{"name":61,"class":6},"Mayo Clinic",{"name":63,"class":6},"Society for Vascular Surgery",{"name":65,"class":6},"American College of Cardiology","100227622","the-crest-2-registry-100227622",false,"NCT02240862","The CREST-2 Registry","C2R","Inclusion Criteria\n\nAsymptomatic patients:\n\nAge ≥ 18 and ≤ 80 and any one of the following\n\n1. ≥70% stenosis, standard surgical risk for CEA\n2. ≥70% stenosis, high anatomic risk for CEA\n3. ≥70% stenosis, high physiologic risk for CEA\n\nSymptomatic patients:\n\nSymptomatic patients are defined by the following characteristics: Ipsilateral carotid Transient Ischemic Attack (TIA), with neurologic symptoms persisting less than 24 hours; Ipsilateral non-disabling stroke: Modified Rankin Scale (mRS) ≤ 3; and Ipsilateral transient monocular blindness: amaurosis fugax. \\[Source: current Medicare NCD for CAS\\]\n\nAge ≥ 18 and ≤ 80 and any one of the following\n\n1. ≥50% stenosis, standard surgical risk for CEA\n2. 50% to 69% stenosis, high anatomic risk for CEA\n3. 50% to 69% stenosis, high physiologic risk\n4. ≥70% stenosis, high anatomic and\u002For physiologic risk for CEA - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R\n5. ≥70% stenosis, post-CEA and -CAS - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R\n6. ≥70% stenosis, post-irradiation - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R\n\nExclusion Criteria:\n\nPatients with any one of the following conditions are ineligible for enrollment in C2R\n\n1. NYHA Class IV CHF\n2. COPD on chronic continuous oxygen therapy\n3. Severe (Class Childs D) liver failure\n4. End-stage renal failure requiring dialysis\n5. Cancer with metastatic spread and\u002For undergoing active chemotherapeutic treatment\n6. Any dementia considered greater than \"mild\"","ALL","18 Years","80 Years",{"count":77,"type":78},8000,"ESTIMATED","12 Months","OBSERVATIONAL","The objective of C2R is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with severe symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid artery stenting (CAS) performed by experienced and skilled interventionists. Interventionists' eligibility will be determined by a multi-specialty Interventional Management Committee (IMC). Patient eligibility will include patients with standard or high-risk, symptomatic or asymptomatic carotid artery disease. Patients will be followed for the occurrence of post-procedural complications. The primary safety and quality endpoint will be the occurrence of any stroke or death within the 30-day period following the stenting procedure. The safety and quality results from C2R will guide selection of interventionists for participation in the CREST-2 randomized clinical trial. Enrollment into C2R will begin in 2015 and continue until publication of the primary results of the randomized trial.",[83],"Carotid Artery Diseases","2026-02-16",{"date":86,"type":87},"2026-02-18","ACTUAL",{"date":89,"type":87},"2015-02",{"date":91,"type":78},"2027-01-31",{"name":5,"class":6},1]