[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516231":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":47,"responsibleParty":522,"collaborators":45,"id":524,"slug":45,"hasResults":525,"nctId":526,"briefTitle":527,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":525,"sex":530,"minAge":531,"maxAge":45,"enrollmentInfo":532,"targetDuration":45,"studyType":535,"phases":536,"briefSummary":538,"conditions":539,"keywords":550,"overallStatus":50,"whyStopped":45,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":570},{"fullName":5,"class":6},"VenoStent","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm","EXPERIMENTAL","Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery",[13],"Device: SelfWrap Bioabsorbable Perivascular Wrap",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","SHAM_COMPARATOR","AVF creation surgery without any intervention (untreated AVF control, or standard of care)",[19],"Procedure: Untreated AVF Control",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","SelfWrap Bioabsorbable Perivascular Wrap","SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.",[9],[27],"SelfWrap",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","Untreated AVF Control","AVF creation surgery without any intervention",[15],[34],"Standard of Care",[36],{"name":37,"affiliation":38,"role":39},"Timothy Boire, PhD","VenoStent, Inc.","STUDY_DIRECTOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Mark Barakat, MD","CONTACT","(832) 429-5362",null,"mark.barakat@venostent.com",[48,68,83,97,112,129,145,164,180,199,216,236,254,269,285,305,323,339,353,371,389,408,426,443,461,477,492,508],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"AKDHC Bullhead City","RECRUITING","Bullhead City","Arizona","86442","United States",{"type":56,"coordinates":57},"Point",[58,59],-114.5683,35.14778,{"lat":59,"lon":58},[62,65],{"name":63,"role":43,"phone":45,"phoneExt":45,"email":64},"Cynthia Carrizoza","ccarrizoza@akdhc.com",{"name":66,"role":67,"phone":45,"phoneExt":45,"email":45},"Rick Mishler, MD","PRINCIPAL_INVESTIGATOR",{"facility":69,"status":50,"city":70,"state":52,"zip":71,"country":54,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"AKDHC Marana Surgery Center","Marana","85658",{"type":56,"coordinates":73},[74,75],-111.22538,32.43674,{"lat":75,"lon":74},[78,81],{"name":79,"role":43,"phone":45,"phoneExt":45,"email":80},"Anell S Munoz Gallego","amgallego@akdhc.com",{"name":82,"role":67,"phone":45,"phoneExt":45,"email":45},"Zhongguang (Ziggy) Yang, MD, PhD",{"facility":84,"status":50,"city":85,"state":52,"zip":86,"country":54,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center","Phoenix","85012",{"type":56,"coordinates":88},[89,90],-112.07404,33.44838,{"lat":90,"lon":89},[93,95],{"name":63,"role":43,"phone":94,"phoneExt":45,"email":64},"(602) 200-8288",{"name":96,"role":67,"phone":45,"phoneExt":45,"email":45},"Shouwen Wang, MD, PhD",{"facility":98,"status":50,"city":99,"state":52,"zip":100,"country":54,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Banner University Medical Center","Tucson","85724",{"type":56,"coordinates":102},[103,104],-110.92648,32.22174,{"lat":104,"lon":103},[107,110],{"name":108,"role":43,"phone":45,"phoneExt":45,"email":109},"Jennifer Lopez","jpinedalopez@arizona.edu",{"name":111,"role":67,"phone":45,"phoneExt":45,"email":45},"Wei Zhou, MD",{"facility":113,"status":50,"city":114,"state":115,"zip":116,"country":54,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Orange County Vascular Access Center","Garden Grove","California","92840",{"type":56,"coordinates":118},[119,120],-117.94145,33.77391,{"lat":120,"lon":119},[123,127],{"name":124,"role":43,"phone":125,"phoneExt":45,"email":126},"Nicole Hilton","803-252-3373","Nicole.Hilton@azuracare.com",{"name":128,"role":67,"phone":45,"phoneExt":45,"email":45},"Steven Posner, MD",{"facility":130,"status":50,"city":131,"state":132,"zip":133,"country":54,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Tallahassee Research Institute","Tallahassee","Florida","32308",{"type":56,"coordinates":135},[136,137],-84.28073,30.43826,{"lat":137,"lon":136},[140,143],{"name":141,"role":43,"phone":45,"phoneExt":45,"email":142},"Brianna Everett","hopefullybrianna@gmail.com",{"name":144,"role":67,"phone":45,"phoneExt":45,"email":45},"Andres Vargas, MD",{"facility":146,"status":50,"city":147,"state":148,"zip":149,"country":54,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Lutheran Medical Group","Fort Wayne","Indiana","46804",{"type":56,"coordinates":151},[152,153],-85.12886,41.1306,{"lat":153,"lon":152},[156,160,162],{"name":157,"role":43,"phone":158,"phoneExt":45,"email":159},"Barbara Anderson","260-458-3555","banderson2@lutheran-hosp.com",{"name":161,"role":43,"phone":45,"phoneExt":45,"email":45},"Sharon Eichman",{"name":163,"role":67,"phone":45,"phoneExt":45,"email":45},"Vincent Scavo, MD",{"facility":165,"status":50,"city":166,"state":167,"zip":168,"country":54,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Surgical Associates of Lexington","Lexington","Kentucky","40503",{"type":56,"coordinates":170},[171,172],-84.47772,37.98869,{"lat":172,"lon":171},[175,178],{"name":176,"role":43,"phone":45,"phoneExt":45,"email":177},"Amanda Gaddis","gaddisak@yahoo.com",{"name":179,"role":67,"phone":45,"phoneExt":45,"email":45},"Colby Atkins, MD",{"facility":181,"status":50,"city":182,"state":183,"zip":184,"country":54,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Brigham and Women's Hospital","Boston","Massachusetts","02115",{"type":56,"coordinates":186},[187,188],-71.05977,42.35843,{"lat":188,"lon":187},[191,194,197],{"name":192,"role":43,"phone":45,"phoneExt":45,"email":193},"Navya Kotturu","nkotturu@bwh.harvard.edu",{"name":195,"role":43,"phone":45,"phoneExt":45,"email":196},"Danielle Montano","dmontano2@bwh.harvard.edu",{"name":198,"role":67,"phone":45,"phoneExt":45,"email":45},"Mohamad Hussain, MD, PhD",{"facility":200,"status":50,"city":201,"state":202,"zip":203,"country":54,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Mayo Clinic","Rochester","Minnesota","55905",{"type":56,"coordinates":205},[206,207],-92.4699,44.02163,{"lat":207,"lon":206},[210,214],{"name":211,"role":43,"phone":212,"phoneExt":45,"email":213},"Jess Schneider","507-284-2511","schneider.jessica1@mayo.edu",{"name":215,"role":67,"phone":45,"phoneExt":45,"email":45},"Randall DeMartino, MD",{"facility":217,"status":50,"city":218,"state":219,"zip":220,"country":54,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"University of Missouri","Columbia","Missouri","65212",{"type":56,"coordinates":222},[223,224],-92.33407,38.95171,{"lat":224,"lon":223},[227,231,234],{"name":228,"role":43,"phone":229,"phoneExt":45,"email":230},"Brianna Ledbetter","573-882-4387","balg34@health.missouri.edu",{"name":232,"role":43,"phone":229,"phoneExt":45,"email":233},"Jennifer Randolph","randolphjl@health.missouri.edu",{"name":235,"role":67,"phone":45,"phoneExt":45,"email":45},"Jonathan Bath, MD",{"facility":237,"status":50,"city":238,"state":219,"zip":239,"country":54,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Saint Louis University","St Louis","63104",{"type":56,"coordinates":241},[242,243],-90.19789,38.62727,{"lat":243,"lon":242},[246,249,252],{"name":247,"role":43,"phone":45,"phoneExt":45,"email":248},"Kathryn Lindsay","kathryn.lindsay@health.slu.edu",{"name":250,"role":43,"phone":45,"phoneExt":45,"email":251},"Craig Dedert","craig.dedert@health.slu.edu",{"name":253,"role":67,"phone":45,"phoneExt":45,"email":45},"Matthew Smeds, MD",{"facility":255,"status":50,"city":238,"state":219,"zip":256,"country":54,"cosmosGeoPoint":257,"geoPoint":259,"contacts":260},"Washington University School of Medicine","63110",{"type":56,"coordinates":258},[242,243],{"lat":243,"lon":242},[261,264,267],{"name":262,"role":43,"phone":45,"phoneExt":45,"email":263},"Ashley Cosentino","ashley.cosentino@wustl.edu",{"name":265,"role":43,"phone":45,"phoneExt":45,"email":266},"Laura McDonald","m.laura@wustl.edu",{"name":268,"role":67,"phone":45,"phoneExt":45,"email":45},"Mohamed Zayed, MD, PhD",{"facility":270,"status":50,"city":271,"state":272,"zip":273,"country":54,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"Northwell Health","Lake Success","New York","11042",{"type":56,"coordinates":275},[276,277],-73.71763,40.77066,{"lat":277,"lon":276},[280,283],{"name":281,"role":43,"phone":45,"phoneExt":45,"email":282},"Victoria Wairimu","mwairimu@northwell.edu",{"name":284,"role":67,"phone":45,"phoneExt":45,"email":45},"Yana Etkin, MD",{"facility":286,"status":50,"city":287,"state":288,"zip":289,"country":54,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"Surgical Specialists of Charlotte, P.A.","Charlotte","North Carolina","28226",{"type":56,"coordinates":291},[292,293],-80.84313,35.22709,{"lat":293,"lon":292},[296,300,303],{"name":297,"role":43,"phone":298,"phoneExt":45,"email":299},"Decca Taylor","(704) 945-3560","dtaylor@ssclt.com",{"name":301,"role":43,"phone":45,"phoneExt":45,"email":302},"Crystal Turner","cturner@ssclt.com",{"name":304,"role":67,"phone":45,"phoneExt":45,"email":45},"Jason Burgess, MD",{"facility":306,"status":50,"city":307,"state":288,"zip":308,"country":54,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"WakeMed","Raleigh","27610",{"type":56,"coordinates":310},[311,312],-78.63861,35.7721,{"lat":312,"lon":311},[315,319,321],{"name":316,"role":43,"phone":317,"phoneExt":45,"email":318},"Jenna Cassels","919-350-5252","jcassels@wakemed.org",{"name":320,"role":43,"phone":45,"phoneExt":45,"email":45},"Rhonda Norton",{"name":322,"role":67,"phone":45,"phoneExt":45,"email":45},"Kirk Charles, MD",{"facility":324,"status":50,"city":325,"state":326,"zip":327,"country":54,"cosmosGeoPoint":328,"geoPoint":332,"contacts":333},"MUSC Charleston","Charleston","South Carolina","29425",{"type":56,"coordinates":329},[330,331],-79.93275,32.77632,{"lat":331,"lon":330},[334,337],{"name":335,"role":43,"phone":45,"phoneExt":45,"email":336},"Natalie Koren","korenn@musc.edu",{"name":338,"role":67,"phone":45,"phoneExt":45,"email":45},"Adam Tanious, MD",{"facility":340,"status":50,"city":218,"state":326,"zip":341,"country":54,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"Vascular Care of South Carolina","29203",{"type":56,"coordinates":343},[344,345],-81.03481,34.00071,{"lat":345,"lon":344},[348,351],{"name":349,"role":43,"phone":125,"phoneExt":45,"email":350},"Alicia Phillips-Pough, RN","alicia.phillips-pough@azuracare.com",{"name":352,"role":67,"phone":45,"phoneExt":45,"email":45},"Dion Franga, MD",{"facility":354,"status":50,"city":355,"state":326,"zip":356,"country":54,"cosmosGeoPoint":357,"geoPoint":361,"contacts":362},"MUSC Black River","Florence","29505",{"type":56,"coordinates":358},[359,360],-79.76256,34.19543,{"lat":360,"lon":359},[363,366,369],{"name":364,"role":43,"phone":45,"phoneExt":45,"email":365},"Patricia Robinson","robinpat@musc.edu",{"name":367,"role":43,"phone":45,"phoneExt":45,"email":368},"Tannesha Clements","clemtann@musc.edu",{"name":370,"role":67,"phone":45,"phoneExt":45,"email":45},"Cary Brewton, DO",{"facility":372,"status":50,"city":373,"state":326,"zip":374,"country":54,"cosmosGeoPoint":375,"geoPoint":379,"contacts":380},"Prisma Health","Greenville","29615",{"type":56,"coordinates":376},[377,378],-82.39401,34.85262,{"lat":378,"lon":377},[381,384,387],{"name":382,"role":43,"phone":45,"phoneExt":45,"email":383},"Kya Spann","Kya.Spann@prismahealth.org",{"name":385,"role":43,"phone":45,"phoneExt":45,"email":386},"Nikita Kasinger","Nikita.Kasinger@PrismaHealth.org",{"name":388,"role":67,"phone":45,"phoneExt":45,"email":45},"Christopher Carsten, MD",{"facility":390,"status":50,"city":391,"state":326,"zip":392,"country":54,"cosmosGeoPoint":393,"geoPoint":397,"contacts":398},"Medical University of South Carolina (MUSC) Orangeburg \u002F Dialysis Access Institute","Orangeburg","29118",{"type":56,"coordinates":394},[395,396],-80.85565,33.49182,{"lat":396,"lon":395},[399,403,406],{"name":400,"role":43,"phone":401,"phoneExt":45,"email":402},"Virginia Anderson","(803) 395-3878","andersvi@musc.edu",{"name":404,"role":43,"phone":45,"phoneExt":45,"email":405},"Amy Lawson","lawsoamy@musc.edu",{"name":407,"role":67,"phone":45,"phoneExt":45,"email":45},"Mark London, MD",{"facility":409,"status":50,"city":410,"state":326,"zip":411,"country":54,"cosmosGeoPoint":412,"geoPoint":416,"contacts":417},"Spartanburg Regional Medical Center","Spartanburg","29650",{"type":56,"coordinates":413},[414,415],-81.93205,34.94957,{"lat":415,"lon":414},[418,421,424],{"name":419,"role":43,"phone":45,"phoneExt":45,"email":420},"Darla Howard","DHoward@srhs.com",{"name":422,"role":43,"phone":45,"phoneExt":45,"email":423},"Shannon Stancil","SStancil@srhs.com",{"name":425,"role":67,"phone":45,"phoneExt":45,"email":45},"Ari Kramer, MD",{"facility":427,"status":50,"city":428,"state":429,"zip":430,"country":54,"cosmosGeoPoint":431,"geoPoint":435,"contacts":436},"James Eric Gardner, MD, PC","Memphis","Tennessee","38115",{"type":56,"coordinates":432},[433,434],-90.04898,35.14953,{"lat":434,"lon":433},[437,441],{"name":438,"role":43,"phone":439,"phoneExt":45,"email":440},"Hannah Gardner","901-493-7821","hannahgardner3@gmail.com",{"name":442,"role":67,"phone":45,"phoneExt":45,"email":45},"James E Gardner, MD",{"facility":444,"status":50,"city":445,"state":446,"zip":447,"country":54,"cosmosGeoPoint":448,"geoPoint":452,"contacts":453},"Saint David's HealthCare Partnership, L.P., LLP","Austin","Texas","78701",{"type":56,"coordinates":449},[450,451],-97.74306,30.26715,{"lat":451,"lon":450},[454,459],{"name":455,"role":43,"phone":456,"phoneExt":457,"email":458},"Shir Yelovitch, PhD","(512) 459-3300","214","SYelovitch@ctvstexas.com",{"name":460,"role":67,"phone":45,"phoneExt":45,"email":45},"Ryan Turley, MD",{"facility":462,"status":50,"city":463,"state":446,"zip":464,"country":54,"cosmosGeoPoint":465,"geoPoint":469,"contacts":470},"A&V Doctors PLLC","El Paso","79912",{"type":56,"coordinates":466},[467,468],-106.48693,31.75872,{"lat":468,"lon":467},[471,475],{"name":472,"role":43,"phone":473,"phoneExt":45,"email":474},"Joshua Crawford","915-307-7800","jcrawford@arteriesveins.com",{"name":476,"role":67,"phone":45,"phoneExt":45,"email":45},"Emmanuel Anekwe, MD",{"facility":478,"status":50,"city":479,"state":446,"zip":480,"country":54,"cosmosGeoPoint":481,"geoPoint":485,"contacts":486},"Houston Methodist Research Institute","Houston","77030",{"type":56,"coordinates":482},[483,484],-95.36327,29.76328,{"lat":484,"lon":483},[487,490],{"name":488,"role":43,"phone":45,"phoneExt":45,"email":489},"Caroline Antunes","cantunes@houstonmethodist.org",{"name":491,"role":67,"phone":45,"phoneExt":45,"email":45},"Eric Peden, MD",{"facility":493,"status":50,"city":494,"state":446,"zip":495,"country":54,"cosmosGeoPoint":496,"geoPoint":500,"contacts":501},"Upper Valley Dialysis Access Center, LLC","Mission","78572",{"type":56,"coordinates":497},[498,499],-98.32529,26.21591,{"lat":499,"lon":498},[502,506],{"name":503,"role":43,"phone":504,"phoneExt":45,"email":505},"Martha Perez","956-600-8899","martha.perez@uvdac.com",{"name":507,"role":67,"phone":45,"phoneExt":45,"email":45},"Chijoke Ogbu, MD",{"facility":509,"status":50,"city":510,"state":446,"zip":511,"country":54,"cosmosGeoPoint":512,"geoPoint":516,"contacts":517},"Houston Methodist Research Institute (Sugar Land)","Sugar Land","77479",{"type":56,"coordinates":513},[514,515],-95.63495,29.61968,{"lat":515,"lon":514},[518,521],{"name":519,"role":43,"phone":45,"phoneExt":45,"email":520},"Sheila Moore","srmoore@houstonmethodist.org",{"name":491,"role":67,"phone":45,"phoneExt":45,"email":45},{"type":523,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100516231",false,"NCT06001827","SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study","SAVE-FistulaS","Inclusion Criteria:\n\n* Age of at least 18 years\n* Referred for creation of a new AVF\n* Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months\n\nExclusion Criteria:\n\n* Planned index procedure to revise or repair an existing fistula\n* Target artery inner diameter \\\u003C 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia\n* Target vein inner diameter \\\u003C 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia\n* Significant (at least 50%) stenosis at the target vein on the side of surgery (between the planned anastomosis site and the axillary vein), as diagnosed by preoperative ultrasound\n* Known central venous stenosis of at least 50% on the side of surgery\n* Presence of a stent or a stent graft within the access circuit\n* Known or suspected coagulation disorder that, in the opinion of the Investigator, puts too much risk on the patient for AVF creation\n* Known or suspected active infection at the time of surgery\n* Congestive heart failure NYHA class 4\n* Prior steal on the side of surgery;\n* Enrolled in another investigational drug, device, or biological study, or was previously enrolled in this study\n* Life expectancy less than 12 months\n* Expected to undergo kidney transplant surgery within 6 months of enrollment\n* Expected to undergo home hemodialysis\n* Females of childbearing potential (premenopausal and not surgically sterile) without documented current negative pregnancy test at screening\n* Presence of a comorbid condition that, in the opinion of the Investigator, may significantly confound the collection of safety and efficacy data in this study\n* Unwillingness or inability to give consent and\u002For comply with the study follow up schedule\n* Any health condition, which in the opinion of the Investigator, would interfere with the safety of the participant or the participant's ability to comply with the study.","ALL","18 Years",{"count":533,"type":534},600,"ESTIMATED","INTERVENTIONAL",[537],"NA","This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.",[540,541,542,543,544,545,546,547,548,549],"Chronic Kidney Diseases","End Stage Renal Disease","Arteriovenous Fistula","Hemodialysis Access Failure","ESRD","Vascular Access Complication","Renal Failure","Catheter Complications","Catheter Dysfunction","Renal Insufficiency",[551,552,553,554,555,556,557,558,559,541,542,560],"Vascular Surgery","Vascular Access","Nephrology","Bioabsorbable","Perivascular Wrap","External Support","Hemodialysis","Dialysis","Chronic Kidney Disease","AVF","2026-02-12",{"date":563,"type":564},"2026-02-17","ACTUAL",{"date":566,"type":564},"2024-01-03",{"date":568,"type":534},"2029-12",{"name":5,"class":6},28]