[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemodialysis-access\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemodialysis-access":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"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":21,"type":22},126,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Chronic Kidney Disease","Hemodialysis Access","Arteriovenous Fistula","End Stage Renal Disease (ESRD)",[33,34,35,36,30,37,15,38],"percutaneous AVF","pAVF","endovascular AVF","endoAVF","AVF","VENOS3","RECRUITING","2026-06-13",{"date":42,"type":43},"2026-06-16","ACTUAL",{"date":45,"type":43},"2025-10-21",{"date":47,"type":22},"2030-09",{"name":49,"class":50},"Venova Medical","INDUSTRY",12,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100621546","single-needle-distal-return-for-long-term-arteriovenous-fistula-care-100621546","NCT07372027","Single-Needle Distal Return for Long-Term Arteriovenous Fistula Care","A Prospective Study on the Efficacy and Cost-Effectiveness of Modified Single-Needle Distal Return Cannulation for Long-Term Arteriovenous Fistula Care in Maintenance Hemodialysis Patients","Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years).\n\nDiagnosis of end-stage kidney disease (ESKD) requiring maintenance hemodialysis (three times per week).\n\nReliable use of a native arteriovenous fistula (AVF) as the primary vascular access for at least the past 3 months.\n\nWilling and able to provide written informed consent to participate in the study.\n\nAdequate superficial venous vasculature in at least one lower extremity (e.g., dorsal foot veins, saphenous tributaries) as assessed by clinical evaluation and\u002For bedside ultrasound, deemed suitable for cannulation as a venous return site.\n\nFor the experimental (SNDR) group: Expressed willingness to adopt the single-needle distal return cannulation strategy.\n\nFor the control group: Currently receiving and willing to continue standard two-needle AVF cannulation.\n\nExclusion Criteria:\n\n* Active systemic infection or localized infection at the potential cannulation sites (AVF or lower extremity veins).\n\nKnown severe coagulation disorder or thrombocytopenia (platelet count \\\u003C 50 × 10⁹\u002FL) that would pose a high risk of bleeding complications from cannulation.\n\nSevere peripheral arterial disease or venous insufficiency in the lower extremities that contraindicates venous cannulation or may compromise limb perfusion.\n\nUnstable cardiovascular status (e.g., uncontrolled heart failure, severe arrhythmias) as determined by the treating nephrologist, which would increase the risk associated with any change in dialysis procedure.\n\nDocumented severe cognitive impairment, psychiatric illness, or any condition that would impair the ability to provide informed consent or adhere to the study protocol.\n\nLife expectancy less than 12 months due to non-renal comorbid conditions (e.g., metastatic malignancy).\n\nCurrently pregnant or breastfeeding.\n\nParticipation in another interventional clinical trial that could confound the outcomes of this study.\n\nAnatomical or pathological condition of the AVF (e.g., extreme depth, aneurysm with overlying skin compromise, complete thrombosis) that precludes safe single-needle cannulation, as judged by the study vascular access team.\n\nInability to comply with the scheduled study visits and follow-up assessments.","100 Years",{"count":61,"type":22},100,[25],"Background:\n\nFor millions of people worldwide with kidney failure, a well-functioning vascular access, like an arteriovenous fistula (AVF), is essential for life-sustaining hemodialysis. However, the standard method requires puncturing the same AVF with two needles three times a week, which over time can damage the vessel, leading to scarring, narrowing, and frequent failures. These complications often require repeated surgical or minimally invasive procedures (reinterventions), causing significant pain, high medical costs, and exhaustion of the patient's limited blood vessels.\n\nNew Approach:\n\nThis study will evaluate a modified puncture technique called the Single-Needle Distal Return (SNDR) strategy for long-term AVF care. Instead of using two needles in the AVF, only one needle is placed in the AVF to draw blood. The cleaned blood is then returned to the body through a second needle placed in a superficial vein in the foot or lower leg. This approach aims to reduce trauma to the critical AVF.\n\nStudy Plan:\n\nThis is a clinical study conducted at the Blood Purification Center of Anhui Medical University Affiliated Suzhou Hospital. We plan to enroll approximately 50 adult hemodialysis patients who use an AVF and are willing to try the SNDR technique. For comparison, we will also observe data from a similar number of patients receiving standard two-needle AVF care during the same period.\n\nThe study will last about three years. We will closely monitor patients using the SNDR technique to assess:\n\nEffectiveness: Whether dialysis remains adequate (measured by Kt\u002FV).\n\nSafety: Rates of complications (like bruising or infection), dialysis machine alarms, and venous pressure during treatment.\n\nPractical Benefits: Whether it reduces the need for repair procedures (reinterventions) and hospitalizations related to the AVF.\n\nEconomic Impact: Changes in healthcare costs.\n\nPatient Experience: Patient tolerance and comfort with the technique. We will also analyze the characteristics of patients who successfully use this technique long-term to help identify who might benefit most from it in the future.\n\nPotential Significance:\n\nIf proven successful and safe for long-term use, the SNDR strategy could help protect a patient's precious AVF, potentially reducing painful procedures, lowering costs, slowing down the exhaustion of blood vessels, and improving the quality of life for people on long-term dialysis. The findings may also guide better planning for vascular access care.",[29,30,65,66,67],"Arteriovenous Fistula Cannulation","Vascular Access","Vascular Access Complication","2026-01-19",{"date":70,"type":43},"2026-01-28",{"date":72,"type":22},"2026-12-15",{"date":74,"type":22},"2026-12-31",{"name":76,"class":77},"Suzhou Municipal Hospital of Anhui Province","OTHER",1]