[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620152":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":50,"studyPopulation":39,"armGroups":51,"interventions":63,"overallOfficials":72,"centralContacts":77,"locations":87,"responsibleParty":218,"collaborators":220,"id":224,"slug":39,"hasResults":225,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":225,"sex":230,"minAge":231,"maxAge":39,"enrollmentInfo":232,"targetDuration":39,"studyType":235,"phases":236,"briefSummary":238,"conditions":239,"keywords":242,"overallStatus":90,"whyStopped":39,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},{"fullName":5,"class":6},"Baylor Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Patency","Freedom from restenosis ≥50% or an increase in Duplex Ultrasound peak systolic velocity ≥2.5 times reference proximal segment or target lesion revascularization (TLR).","From enrollment to 6 months",[14,18,22,26,29,32,35],{"measure":15,"description":16,"timeFrame":17},"Technical Success","Technical success is defined as less than 30% residual stenosis in the target lesion following the index procedure. Residual stenosis determined by operator visual estimation.","Collected from index procedure",{"measure":19,"description":20,"timeFrame":21},"Procedural Success","Procedural success is technical success (less than 30 % residual stenosis in the target lesion) without the occurrence of procedural complications during the index procedure. Residual stenosis determined by operator visual estimation.","Collected from Index procedure",{"measure":23,"description":24,"timeFrame":25},"Clinically driven-TLR (CD-TLR)","Clinically driven-target limb revascularization. Information collected from the medical record.","From enrollment to 12 months",{"measure":27,"description":28,"timeFrame":25},"Amputation-free Survival","Defined as no evidence of amputation. Information is collected from the medical record",{"measure":30,"description":31,"timeFrame":25},"Functional Status Improvement (Vascular Quality of Life Questionnaire (VascuQoL-6))","Vascular Quality of Life Questionnaire (VascuQoL-6) collected at index procedure and 12 months.",{"measure":33,"description":34,"timeFrame":25},"Functional Status Improvement (Rutherford Class Improvement)","Rutherford class determined by physician and collected from the medical record.",{"measure":36,"description":37,"timeFrame":38},"Cost Effectiveness","This analysis will calculate total cost-effectiveness by comparing costs between the two groups. Total cost will include the initial procedural cost, costs related to complications, and costs of any repeat reinterventions during follow-up.","Evaluated at 12 months",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":39,"timePerspective":39,"maskingInfo":45},"RANDOMIZED","PARALLEL","Prospective randomized controlled study.","TREATMENT",{"masking":46,"maskingDescription":47,"whoMasked":48},"SINGLE","Single-blind",[49],"PARTICIPANT","This is a U.S. prospective multicenter randomized controlled trial to evaluate the clinical outcomes of Intravascular ultrasound (IVUS) guided Lower Extremity (LE) endovascular intervention in patients with symptomatic peripheral artery disease (PAD) (Rutherford class 2-5).",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"Intravascular Ultrasound (IVUS)","ACTIVE_COMPARATOR","Intravascular Ultrasound (IVUS) is used during the treatment of the target lesion.",[57],"Device: Intravascular Ultrasound (IVUS)",{"label":59,"type":54,"description":60,"interventionNames":61},"Non-Intravascular Ultrasound (IVUS)","Intravascular Ultrasound (IVUS) is not used in the treatment of the target lesion.",[62],"Device: Angiographic-guided Intervention",[64,68],{"type":65,"name":53,"description":66,"armGroupLabels":67,"otherNames":39},"DEVICE","pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and\u002For stent placement",[53],{"type":65,"name":69,"description":70,"armGroupLabels":71,"otherNames":39},"Angiographic-guided Intervention","Standard angiography-guided intervention without IVUS.",[59],[73],{"name":74,"affiliation":75,"role":76},"Subhash Banerjee, MD","Baylor Scott & White Research Institute","PRINCIPAL_INVESTIGATOR",[78,83],{"name":79,"role":80,"phone":81,"phoneExt":39,"email":82},"Sarah Hale","CONTACT","469-814-4845","sarah.hale@bswhealth.org",{"name":84,"role":80,"phone":85,"phoneExt":39,"email":86},"Sarah Weideman","214-820-2927","sarah.weideman@bswhealth.org",[88,113,130,155,183,204],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Baylor Scott & White The Heart Hospital - Dallas","RECRUITING","Dallas","Texas","75226","United States","US",{"type":97,"coordinates":98},"Point",[99,100],-96.80667,32.78306,{"lat":100,"lon":99},[103,104,105,106,109,111],{"name":79,"role":80,"phone":81,"phoneExt":39,"email":82},{"name":84,"role":80,"phone":85,"phoneExt":39,"email":86},{"name":74,"role":76,"phone":39,"phoneExt":39,"email":39},{"name":107,"role":108,"phone":39,"phoneExt":39,"email":39},"Zachary Rosol, MD","SUB_INVESTIGATOR",{"name":110,"role":108,"phone":39,"phoneExt":39,"email":39},"Javier Vasquez, MD",{"name":112,"role":108,"phone":39,"phoneExt":39,"email":39},"Georges Feghali, MD",{"facility":114,"status":115,"city":116,"state":92,"zip":117,"country":94,"countryCode":95,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Baylor Scott & White The Heart Hospital - Fort Worth","NOT_YET_RECRUITING","Fort Worth","76104",{"type":97,"coordinates":119},[120,121],-97.32085,32.72541,{"lat":121,"lon":120},[124,128],{"name":125,"role":80,"phone":126,"phoneExt":39,"email":127},"Theresa Cheyne","817-922-2579","Theresa.Cheyne@BSWHealth.org",{"name":129,"role":76,"phone":39,"phoneExt":39,"email":39},"Mohammad Alqaim, MD",{"facility":131,"status":90,"city":132,"state":92,"zip":133,"country":94,"countryCode":95,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Baylor Scott & White The Heart Hospital - Mckinney","McKinney","75071",{"type":97,"coordinates":135},[136,137],-96.61527,33.19762,{"lat":137,"lon":136},[140,144,147,149,151,153],{"name":141,"role":80,"phone":142,"phoneExt":39,"email":143},"Denise Espinoza","(469) 814-4783","Denise.Espinoza@BSWHealth.org",{"name":145,"role":80,"phone":39,"phoneExt":39,"email":146},"Erisa Stokes, BS","erisa.stokes@bswhealth.org",{"name":148,"role":76,"phone":39,"phoneExt":39,"email":39},"Robert Widmer, MD",{"name":150,"role":108,"phone":39,"phoneExt":39,"email":39},"Arash Shirvani, MD",{"name":152,"role":108,"phone":39,"phoneExt":39,"email":39},"Joseph Liechty, MD",{"name":154,"role":108,"phone":39,"phoneExt":39,"email":39},"Sanjeev Trehan, MD",{"facility":156,"status":90,"city":157,"state":92,"zip":158,"country":94,"countryCode":95,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"The Heart Hospital Baylor Plano","Plano","75093",{"type":97,"coordinates":160},[161,162],-96.69889,33.01984,{"lat":162,"lon":161},[165,169,171,173,175,177,179,181],{"name":166,"role":80,"phone":167,"phoneExt":39,"email":168},"Osniel Gonzalez Ramos, BS","469-814-4862","osniel.gonzalezramos@bswhealth.org",{"name":145,"role":80,"phone":170,"phoneExt":39,"email":146},"469-814-4819",{"name":172,"role":76,"phone":39,"phoneExt":39,"email":39},"Sameh Sayfo, MD",{"name":174,"role":108,"phone":39,"phoneExt":39,"email":39},"Chadi Dib, MD",{"name":176,"role":108,"phone":39,"phoneExt":39,"email":39},"John Kedora, MD",{"name":178,"role":108,"phone":39,"phoneExt":39,"email":39},"Mazin Foteh, MD",{"name":180,"role":108,"phone":39,"phoneExt":39,"email":39},"Srinivasa Potluri, MD",{"name":182,"role":108,"phone":39,"phoneExt":39,"email":39},"Dennis Gable, MD",{"facility":184,"status":115,"city":185,"state":92,"zip":186,"country":94,"countryCode":95,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Baylor Scott & White Medical Center - Temple","Temple","76508",{"type":97,"coordinates":188},[189,190],-97.34278,31.09823,{"lat":190,"lon":189},[193,197,200,202],{"name":194,"role":80,"phone":195,"phoneExt":39,"email":196},"Margarite Grable","254-724-5861","Margarite.Grable@BSWHealth.org",{"name":198,"role":80,"phone":39,"phoneExt":39,"email":199},"Christian Wintz","christian.wintz@bswhealth.org",{"name":201,"role":76,"phone":39,"phoneExt":39,"email":39},"Timothy Mixon, MD",{"name":203,"role":108,"phone":39,"phoneExt":39,"email":39},"Clint Malone, MD",{"facility":205,"status":90,"city":206,"state":92,"zip":207,"country":94,"countryCode":95,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Baylor Scott & White The Heart Hospital - Waxahachie","Waxahachie","75165",{"type":97,"coordinates":209},[210,211],-96.84833,32.38653,{"lat":211,"lon":210},[214,215,216],{"name":79,"role":80,"phone":81,"phoneExt":39,"email":82},{"name":84,"role":80,"phone":85,"phoneExt":39,"email":86},{"name":217,"role":76,"phone":39,"phoneExt":39,"email":39},"Christopher Henry, MD",{"type":219,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[221],{"name":222,"class":223},"Philips Healthcare","INDUSTRY","100620152",false,"NCT07353905","Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries","INVIGOR","Inclusion Criteria:\n\n* Age ≥18 years\n* Symptomatic LE PAD - Rutherford Class 2-5\n* Angiographic evidence of \\>50% stenosis\n* Undergoing LE peripheral artery intervention\n* Target lesion is iliac, femoropopliteal, profunda or supramalleolar below-the-knee arteries (target lesions extending into the abdominal aorta and inframalleolar BTK may be included).\n\nExclusion Criteria:\n\n* Prior intervention at the target lesion within 6 months\n* Target lesion is abdominal aorta or inframalleolar BTK arteries","ALL","18 Years",{"count":233,"type":234},350,"ESTIMATED","INTERVENTIONAL",[237],"NA","This study will test whether using ultrasound imaging within blood vessels during minimally invasive treatment of leg arteries in patients with peripheral artery disease leads to better clinical outcomes.",[240,241],"Peripheral Arterial Disease","Lower Extremity Arterial Disease",[243,244,245],"Intravascular Ultrasound","Angioplasty","Endovascular Treatment","2026-03-17",{"date":248,"type":249},"2026-03-19","ACTUAL",{"date":251,"type":249},"2025-12-12",{"date":253,"type":234},"2028-07",{"name":5,"class":6},6]