[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604778":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":226,"collaborators":22,"id":228,"slug":229,"hasResults":230,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":230,"sex":236,"minAge":237,"maxAge":238,"enrollmentInfo":239,"targetDuration":22,"studyType":242,"phases":243,"briefSummary":245,"conditions":246,"keywords":251,"overallStatus":32,"whyStopped":22,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},{"fullName":5,"class":6},"Venova Medical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Velocity pAVF System Treatment Arm","EXPERIMENTAL","Participants in this single-arm, open-label study will undergo creation of a dialysis access using the Velocity Percutaneous Arteriovenous Fistula (pAVF). The Velocity pAVF is designed to create an arteriovenous fistula (AVF) using a minimally invasive, catheter-based procedure through the skin, rather than open surgery. All subjects enrolled will receive the Velocity pAVF procedure. After the procedure, participants will be followed with physical examinations, duplex ultrasound, and dialysis assessments to evaluate fistula maturation, usability for hemodialysis, and long-term function. Additional procedures, if needed to assist maturation or maintain access function, will be recorded. Safety will be monitored throughout the study, including assessment of device-related and procedure-related complications.",[13],"Device: Velocity Percutaneous Arteriovenous Fistula",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Velocity Percutaneous Arteriovenous Fistula","The Velocity pAVF is a catheter-based device used to create an arteriovenous fistula for hemodialysis access through a minimally invasive, percutaneous procedure. Unlike surgical AVF creation or other pAVF systems, Velocity is designed to simplify the procedure and improve consistency of maturation and long-term function. All participants in this study will undergo AVF creation using the Velocity pAVF.",[9],[21],"Velocity pAVF",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Shant Vartanian, MD","CONTACT","408-242-5897","Venos-3@venovamed.com",[30,51,67,82,99,115,133,149,166,183,201,214],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Trinity Research Group","RECRUITING","Dothan","Alabama","36301","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-85.39049,31.22323,{"lat":42,"lon":41},[45,48],{"name":22,"role":26,"phone":46,"phoneExt":22,"email":47},"334-456-5511","research.trinityresearchgroup@gmail.com",{"name":49,"role":50,"phone":22,"phoneExt":22,"email":22},"Jason Beaver, MD","PRINCIPAL_INVESTIGATOR",{"facility":52,"status":32,"city":53,"state":54,"zip":55,"country":36,"countryCode":37,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"West Coast Kidney Institute Concord","Concord","California","94520",{"type":39,"coordinates":57},[58,59],-122.03107,37.97798,{"lat":59,"lon":58},[62,66],{"name":63,"role":26,"phone":64,"phoneExt":22,"email":65},"Michael Murphy, MD","925-686-1230","michael.murphy@westcoastkidney.com",{"name":63,"role":50,"phone":22,"phoneExt":22,"email":22},{"facility":68,"status":32,"city":69,"state":54,"zip":70,"country":36,"countryCode":37,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Apex Research","Riverside","92505",{"type":39,"coordinates":72},[73,74],-117.39616,33.95335,{"lat":74,"lon":73},[77,80],{"name":22,"role":26,"phone":78,"phoneExt":22,"email":79},"951-687-6300","dzdawoud@namg.net",{"name":81,"role":50,"phone":22,"phoneExt":22,"email":22},"Dalia Dawoud, MD",{"facility":83,"status":32,"city":84,"state":85,"zip":86,"country":36,"countryCode":37,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Vascular and Embolization Specialists","Cocoa","Florida","32926",{"type":39,"coordinates":88},[89,90],-80.742,28.38612,{"lat":90,"lon":89},[93,97],{"name":94,"role":26,"phone":95,"phoneExt":22,"email":96},"Laura Dalton","321-321-3001","forms@vascularembo.com",{"name":98,"role":50,"phone":22,"phoneExt":22,"email":22},"Derek Mittleider, MD",{"facility":100,"status":32,"city":101,"state":85,"zip":102,"country":36,"countryCode":37,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Azura Vascular Care Jacksonville","Jacksonville","32218",{"type":39,"coordinates":104},[105,106],-81.65565,30.33218,{"lat":106,"lon":105},[109,113],{"name":110,"role":26,"phone":111,"phoneExt":22,"email":112},"Christine Mulligan","717-818-0153","Christine.Mulligan@azuracare.com",{"name":114,"role":50,"phone":22,"phoneExt":22,"email":22},"Mark Gorrie, DO",{"facility":116,"status":117,"city":118,"state":119,"zip":120,"country":36,"countryCode":37,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Staten Island University Hospital Northwell Health","NOT_YET_RECRUITING","Staten Island","New York","10305",{"type":39,"coordinates":122},[123,124],-74.13986,40.56233,{"lat":124,"lon":123},[127,131],{"name":128,"role":26,"phone":129,"phoneExt":22,"email":130},"Cindy Lin","718-226-6422","clin14@northwell.edu",{"name":132,"role":50,"phone":22,"phoneExt":22,"email":22},"Vincent Gallo, MD",{"facility":134,"status":32,"city":135,"state":136,"zip":137,"country":36,"countryCode":37,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Surgical Specialists of Charlotte","Charlotte","North Carolina","28207",{"type":39,"coordinates":139},[140,141],-80.84313,35.22709,{"lat":141,"lon":140},[144,148],{"name":145,"role":26,"phone":146,"phoneExt":22,"email":147},"Jason Burgess, MD","704-333-0741","jburgess@ssclt.com",{"name":145,"role":50,"phone":22,"phoneExt":22,"email":22},{"facility":150,"status":32,"city":151,"state":152,"zip":153,"country":36,"countryCode":37,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"MUSC Health Orangeburg- Dialysis Access Institute","Orangeburg","South Carolina","29118",{"type":39,"coordinates":155},[156,157],-80.85565,33.49182,{"lat":157,"lon":156},[160,164],{"name":161,"role":26,"phone":162,"phoneExt":22,"email":163},"Virginia Anderson","803-395-3878","andersvi@musc.edu",{"name":165,"role":50,"phone":22,"phoneExt":22,"email":22},"John Aruny, MD",{"facility":167,"status":32,"city":168,"state":169,"zip":170,"country":36,"countryCode":37,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Aqua Research","Houston","Texas","77058",{"type":39,"coordinates":172},[173,174],-95.36327,29.76328,{"lat":174,"lon":173},[177,181],{"name":178,"role":26,"phone":179,"phoneExt":22,"email":180},"Rhea Sharma","346-800-1300","rheas@aqua-ri.com",{"name":182,"role":50,"phone":22,"phoneExt":22,"email":22},"Rupal Patel, MD",{"facility":184,"status":32,"city":185,"state":169,"zip":186,"country":36,"countryCode":37,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Humble Vascular Surgical Center","Humble","77338",{"type":39,"coordinates":188},[189,190],-95.26216,29.99883,{"lat":190,"lon":189},[193,197,199],{"name":194,"role":26,"phone":195,"phoneExt":22,"email":196},"Ruchdi Barakat, MD","346-616-5862","ruchdi.barakat@surgerypartners.com",{"name":198,"role":50,"phone":22,"phoneExt":22,"email":22},"Brett Stephens, MD",{"name":194,"role":200,"phone":22,"phoneExt":22,"email":22},"SUB_INVESTIGATOR",{"facility":202,"status":32,"city":203,"state":169,"zip":204,"country":36,"countryCode":37,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Fresenius Vascular Care San Antonio","San Antonio","78207",{"type":39,"coordinates":206},[207,208],-98.49363,29.42412,{"lat":208,"lon":207},[211,212],{"name":110,"role":26,"phone":111,"phoneExt":22,"email":112},{"name":213,"role":50,"phone":22,"phoneExt":22,"email":22},"Rashid Sharaf, MD",{"facility":215,"status":32,"city":203,"state":169,"zip":216,"country":36,"countryCode":37,"cosmosGeoPoint":217,"geoPoint":219,"contacts":220},"San Antonio Surgical Center","78216",{"type":39,"coordinates":218},[207,208],{"lat":208,"lon":207},[221,225],{"name":222,"role":26,"phone":223,"phoneExt":22,"email":224},"Rajeev Narayan, MD","210-342-2233","rnarayan@sakidney.com",{"name":222,"role":50,"phone":22,"phoneExt":22,"email":22},{"type":227,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100604778","pivotal-study-of-the-velocity-pavf-system-100604778",false,"NCT07153939","Pivotal Study of the Velocity™ pAVF System","Multicenter Pivotal Study of the Velocity™ Percutaneous Arterio-Venous Fistula System","VENOS-3","Inclusion Criteria:\n\n1. ESRD requiring hemodialysis access or CKD with anticipated need for hemodialysis within 6 months\n2. Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm\n3. Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm\n4. Age \\> 18 years and \\\u003C 80 years\n5. Willing and competent to give written informed consent\n6. Willing and able to complete all study assessments and follow-up requirements\n\nExclusion Criteria:\n\n1. Study extremity systolic blood pressure \\\u003C 100mmHg\n2. Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test\n3. Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF.\n4. Distance between Cubital Perforating Vein and Proximal Radial Artery \\> 3.0 mm\n5. Cephalic vein diameter \\\u003C 2.5 mm at any point from the CPV to the axillary vein\n6. Central venous occlusion ipsilateral of the study extremity\n7. Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment.\n8. Evidence of active systemic infections or localized to the procedure access site within the past 7 days\n9. History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina\n10. Any contraindication to antiplatelet therapy\n11. Currently being treated with another investigational device or drug\n12. Known adverse effects to sedation and\u002For anesthesia which cannot be adequately pre-medicated\n13. Uncontrolled or poorly controlled diabetes defined as a HbA1C \\> 10%\n14. Known hypercoagulable condition, bleeding diathesis or coagulation disorder\n15. Lymphedema of the study extremity\n16. Scheduled kidney transplant within 6 months of enrollment\n17. Peripheral white blood cell count \\\u003C 1,500 cells\u002FμL or \\> 13,000 cells\u002FμL and neutrophil \\> 80%\n18. Platelet count \\\u003C 75,000 cells\u002F μL\n19. Current diagnosis of carcinoma (unless in remission \\> 1 year)\n20. Pregnant or currently breast feeding\n21. Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System\n22. Any other medical condition that in the opinion of the investigator would put the welfare of the subject at risk or confound interpretation of the study data\n23. Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.","ALL","18 Years","80 Years",{"count":240,"type":241},126,"ESTIMATED","INTERVENTIONAL",[244],"NA","This study will evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method for creating dialysis access. People with kidney failure often require dialysis, which depends on having a reliable arteriovenous fistula (AVF). Traditionally, AVFs are created with surgery, but surgery can involve incisions, longer recovery, and sometimes additional procedures before the AVF can be used.\n\nThe Velocity System is designed to create an AVF through a small puncture in the skin using a catheter-based approach, without open surgery. This pivotal study will assess how safe the procedure is and how well it works for patients who need dialysis.\n\nThe study will take place at multiple centers in the United States and will enroll adults with kidney failure who are candidates for fistula creation. Participants will undergo the Velocity procedure and then be followed closely with exams, ultrasounds, and dialysis assessments for up to five years.\n\nTaking part is voluntary. Patients may benefit from a less invasive approach to dialysis access, but the main goal is to collect information that could improve future care for people with kidney failure.",[247,248,249,250],"Chronic Kidney Disease","Hemodialysis Access","Arteriovenous Fistula","End Stage Renal Disease (ESRD)",[252,253,254,255,249,256,234,257],"percutaneous AVF","pAVF","endovascular AVF","endoAVF","AVF","VENOS3","2026-06-13",{"date":260,"type":261},"2026-06-16","ACTUAL",{"date":263,"type":261},"2025-10-21",{"date":265,"type":241},"2030-09",{"name":5,"class":6},12]