[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474217":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":13,"responsibleParty":35,"collaborators":7,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":7,"enrollmentInfo":46,"targetDuration":7,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":7,"overallStatus":55,"whyStopped":7,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},{"fullName":5,"class":6},"Alucent Biomedical","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"COMBINATION_PRODUCT","Vessel Restoration System (VRS)","The VRS includes the following components:\n\n* VRS 10-8-10 Dimer Coated Balloon Catheter\n* VRS Light Fiber\n* VRS Light Source The VRS will collectively refer to all the components used to perform the procedure. Their specific product name will identify individual elements.",[14,26],{"facility":15,"status":7,"city":16,"state":17,"zip":7,"country":18,"countryCode":19,"cosmosGeoPoint":20,"geoPoint":25,"contacts":7},"Flinders Medical Center","Adelaide","South Australia","Australia","AU",{"type":21,"coordinates":22},"Point",[23,24],138.59863,-34.92866,{"lat":24,"lon":23},{"facility":27,"status":7,"city":28,"state":29,"zip":7,"country":18,"countryCode":19,"cosmosGeoPoint":30,"geoPoint":34,"contacts":7},"The Alfred Hospital","Melbourne","Victoria",{"type":21,"coordinates":31},[32,33],144.96332,-37.814,{"lat":33,"lon":32},{"type":36,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100474217","feasibility-study-of-the-vessel-restoration-system-vrs-for-the-treatment-of-atherosclerotic-lesions-in-the-superficial-femoral-artery-sfa-andor-popliteal-artery-pa-after-sub-optimal-percutaneous-transluminal-angioplasty-pta-or-atherectomy-reactivate-i-100474217",false,"NCT05455021","Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and\u002For Popliteal Artery (PA) After Sub-optimal Percutaneous Transluminal Angioplasty (PTA) or Atherectomy: REACTIVATE I","REACTIVATE I","Inclusion Criteria:\n\nSubjects for this study must meet all of the following general eligibility criteria\n\nAND the answer must be \"YES\" to all general inclusion criteria:\n\n1. Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits.\n2. Male or female subject of at least 18 years of age.\n3. Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4.\n4. Has screen failed from the ACTIVATE II study due to the presence of Grade C or D dissection(s).\n\nExclusion Criteria:\n\n1. Life expectancy, documented in the Investigator's opinion, of less than 1 year.\n2. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) or cardiac event (e.g., PCI for STEMI\u002FNSTEMI, unstable angina) within 6 months prior to the index procedure.\n3. Chronic renal insufficiency with serum creatinine ≥ 2.5 mg\u002FdL or eGFR \\\u003C45 ml\u002Fmin within 30 days prior to the index procedure or treatment with peritoneal or hemodialysis.\n4. Subject has a platelet count \\\u003C 100,000 cells\u002Fmm3 or \\> 700,000 cells\u002Fmm3 within 30 days prior to the index procedure or has a history of bleeding diathesis.\n5. Receiving oral or intravenous immunosuppressive therapy.\n6. Subject has white blood cell (WBC) count \\\u003C 3.0 (3,000 cells\u002Fmm3) within 30 days prior to the index procedure.\n7. History of major amputation in the target limb.\n8. Any major intervention planned at the index procedure or within 30 days post-index procedure including treatment of contralateral limb.\n9. Subject is pregnant, breastfeeding, or planning to become pregnant in the next 30 days. Subjects (male and female) of childbearing potential must agree to use effective birth control measures for 30 days after the index procedure.","ALL","18 Years",{"count":47,"type":48},50,"ESTIMATED","INTERVENTIONAL",[51],"NA","Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and\u002For Popliteal Artery (PA) after Sub-optimal percutaneous transluminal angioplasty (PTA) or Atherectomy: REACTIVATE I",[54],"PAD - Peripheral Arterial Disease","ACTIVE_NOT_RECRUITING","2024-01-12",{"date":58,"type":59},"2024-01-16","ACTUAL",{"date":61,"type":59},"2021-11-15",{"date":63,"type":48},"2026-11-15",{"name":5,"class":6},2]