[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100274274":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":40,"centralContacts":23,"locations":45,"responsibleParty":117,"collaborators":119,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":23,"enrollmentInfo":133,"targetDuration":23,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":144,"whyStopped":23,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"VIVA Physicians","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Non-randomized","Directional Atherectomy + Drug Coated Balloon: DA followed by DCB will be performed in all enrolled subjects.\n\nDA includes the use of Intervention 'Medtronic HawkOne® or TurboHawk™.\n\nMedtronic Spider™ Distal Protection Device (DPD) is recommended for use according to IFU.\n\nMedtronic IN.PACT® Admiral® DCB will be used after DA.\n\nVolcano Visions® PV .014\" IVUS catheter required to assess lesion in each procedure.\n\nNitinol Stent Placement: Only FDA approved nitinol stents can be used if provisional stenting is required.",[12,13,14,15,16],"Device: Medtronic HawkOne® or TurboHawk™","Device: Medtronic IN.PACT® Admiral® DCB","Device: Medtronic Spider™ Distal Protection Device (DPD)","Device: Volcano Visions® PV .014\" IVUS catheter","Device: Nitinol Stent Placement",[18,24,28,32,36],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","Medtronic HawkOne® or TurboHawk™","Use of FDA Cleared Directional Atherectomy (DA) Devices. Medtronic HawkOne® Directional Atherectomy System or TurboHawk™ Plaque Excision System. DA followed by DCB will be performed in all enrolled subjects.",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Medtronic IN.PACT® Admiral® DCB","FDA Approved Drug Coated Balloon (DCB) Technology. Medtronic IN.PACT® Admiral® DCB will be used after DA.",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Medtronic Spider™ Distal Protection Device (DPD)","It is recommended that the Medtronic Spider™ Distal protection device (DPD) be paired with DA when used in complex, calcified lesions (TurboHawk™ IFU).",[9],{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"Volcano Visions® PV .014\" IVUS catheter","Lesion IVUS assessment using the Volcano Visions® PV .014\" IVUS catheter will be required in all cases.",[9],{"type":19,"name":37,"description":38,"armGroupLabels":39,"otherNames":23},"Nitinol Stent Placement","Only FDA approved nitinol stents can be used if provisional stenting is required.",[9],[41],{"name":42,"affiliation":43,"role":44},"Krishna Singh, MD","VIVA Physicians, Inc.","PRINCIPAL_INVESTIGATOR",[46,59,69,79,88,98,108],{"facility":47,"status":23,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":23},"Iowa Methodist Medical Center","Des Moines","Iowa","50309","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-93.60911,41.60054,{"lat":57,"lon":56},{"facility":60,"status":23,"city":61,"state":62,"zip":63,"country":51,"countryCode":52,"cosmosGeoPoint":64,"geoPoint":68,"contacts":23},"St. Elizabeth's","Boston","Massachusetts","2135",{"type":54,"coordinates":65},[66,67],-71.05977,42.35843,{"lat":67,"lon":66},{"facility":70,"status":23,"city":71,"state":72,"zip":73,"country":51,"countryCode":52,"cosmosGeoPoint":74,"geoPoint":78,"contacts":23},"University of Mississippi","Jackson","Mississippi","39216",{"type":54,"coordinates":75},[76,77],-90.18481,32.29876,{"lat":77,"lon":76},{"facility":80,"status":23,"city":81,"state":81,"zip":82,"country":51,"countryCode":52,"cosmosGeoPoint":83,"geoPoint":87,"contacts":23},"Mount Sinai","New York","10029",{"type":54,"coordinates":84},[85,86],-74.00597,40.71427,{"lat":86,"lon":85},{"facility":89,"status":23,"city":90,"state":91,"zip":92,"country":51,"countryCode":52,"cosmosGeoPoint":93,"geoPoint":97,"contacts":23},"Rex","Raleigh","North Carolina","27607",{"type":54,"coordinates":94},[95,96],-78.63861,35.7721,{"lat":96,"lon":95},{"facility":99,"status":23,"city":100,"state":101,"zip":102,"country":51,"countryCode":52,"cosmosGeoPoint":103,"geoPoint":107,"contacts":23},"Austin Heart","Austin","Texas","78756",{"type":54,"coordinates":104},[105,106],-97.74306,30.26715,{"lat":106,"lon":105},{"facility":109,"status":23,"city":110,"state":101,"zip":111,"country":51,"countryCode":52,"cosmosGeoPoint":112,"geoPoint":116,"contacts":23},"Longview Cardiac and Vascular Consultants","Longview","75605",{"type":54,"coordinates":113},[114,115],-94.74049,32.5007,{"lat":115,"lon":114},{"type":118,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[120],{"name":121,"class":122},"Medtronic","INDUSTRY","100274274","directional-atherectomy--drug-coated-balloon-to-treat-long-calcified-femoropopliteal-artery-lesions-100274274",false,"NCT02850107","DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions","The REALITY Study: DiRectional AthErectomy + Drug-CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions","REALITY","Inclusion Criteria:\n\nGeneral Inclusion Criteria:\n\n1. Willing and able to provide informed consent;\n2. Age ≥ 18 years of age;\n3. Clinical evaluation determines Rutherford Category 2-4;\n4. Willing to comply with all study requirements;\n5. All lab work is within acceptable limits to undergo a percutaneous interventional procedure.\n6. Life expectancy, in the investigator's opinion, of at least 24 months.\n\nAngiographic Inclusion Criteria:\n\n1. RVD ≥ 4mm and ≤ 7mm;\n2. Evidence of a ≥70% de novo or restenotic lesion or occlusion in the target lesion defined as in the superficial femoral artery and\u002For popliteal artery, located in the arterial segment starting at least 1 cm beyond the Common Femoral Artery (CFA) bifurcation between the superficial and profunda femoris arteries (proximal anatomical landmark) to the distal P2 segment of the popliteal artery;\n3. Total lesion\u002Focclusion length:\n\n   a. ≥ 8 cm and ≤ 18 cm\n4. Total occlusion length\n\n   a. ≥ 6 cm and ≤10 cm\n5. Stenosis or occlusion begins 1cm below the profunda-SFA bifurcation;\n6. Femoral or popliteal stenosis or occlusion that does not extend beyond the P2 popliteal segment;\n7. Minimum 1 patent infrapopliteal vessel to the foot with ≤ 50% diameter stenosis;\n8. Grade 3 or 4 intimal, medial and\u002For mixed calcification per the PACSS as judged by the operator at the time of the procedure;\n9. Index lesion fits within guidelines below:\n\n   9.1 If two lesions are ≤ 3 cm apart, treatment would be allowed as a single lesion providing they contain a segment of moderate or severe calcification and the total lesion length is ≥ 8 cm and ≤18 cm.\n\n   9.2 If more than one lesion is within the target vessel, and they are separated by \\> 3 cm of normal vessel, one lesion must be designated by the investigator as the target lesion as long as the lesion meets all angiographic eligibility criteria. Only one index lesion is permitted for analysis, but study will allow a second lesion to be treated as a non-target lesion.\n10. Infrapopliteal lesion, if diagnosed, can be staged and treated \\> 30 days after index procedure.\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria:\n\n1. Renal failure or chronic kidney disease with GFR ≤30 ml\u002Fmin or MDRD GFR ≤30 ml\u002Fmin per 1.73m2 (and serum creatinine ≥2.5 mg\u002FdL within 30 days of index procedure);\n2. Physician does not believe subject is an appropriate candidate for study;\n3. Previous infra-inguinal intervention in the index limb within 30 days of the planned femoropopliteal intervention\n\nAngiographic Exclusion Criteria:\n\n1. Inability to cross lesion\u002Focclusion with a guidewire or re-entry device;\n2. Inability for the guidewire to re-enter and\u002For remain in the true lumen prior to enrollment;\n3. In-stent restenosis of the target lesion, or recognition of any stent (patent or re-stenotic within the femoropopliteal segment of the index limb;\n4. Aneurysm located in the target vessel or aneurysmal vessel;\n5. Acute thrombus in the index limb prior to enrollment.","ALL","18 Years",{"count":134,"type":135},102,"ACTUAL","INTERVENTIONAL",[138],"NA","This study is designed to collect information during a procedure that is routine care for treating a blockage in a blood vessel in the upper part of the participant's leg. This study is for data collection reasons to help doctors gain better understanding of the treatment of disease in the blood vessels of the legs. You will be treated with two devices that are routine, or standard of care, for your doctor to treat blockages in the blood vessel of the leg. The treatment is for a blockage or narrowing caused by plaque build-up in the blood vessel. Data will be collected to assess what length of time the blood vessel will be prevented from re-narrowing through twenty-four (24) months after the procedure.",[141],"Peripheral Vascular Disease",[143],"Atherectomy, Drug-Coated Balloon","COMPLETED","2020-10-15",{"date":147,"type":135},"2020-10-19",{"date":149,"type":135},"2016-06-01",{"date":151,"type":135},"2020-06-16",{"name":5,"class":6},7]