[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06516653":3,"trial-entities:NCT06516653":205,"trial-summary:NCT06516653":209},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":41,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":54,"locations":57,"central_contacts":195,"overall_officials":200,"references":203,"see_also_links":204},"NCT06516653","CD0261","Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula","Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.","RECRUITING","2028-05","2025-10","2026-07-14","2025-01-13","Laminate Medical Technologies","INDUSTRY",false,"VasQ is an external support implant for arteriovenous fistulas created for dialysis access.\n\nThis is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms:\n\n* Treatment arm: End to side fistula supported with VasQ\n* Control: Standard of care end to side fistula","Structure\n\nThis is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms:\n\n* Treatment arm: End to side fistula supported with VasQ\n* Control: Standard of care end to side fistula\n\nDuration The primary endpoint is defined at 6 month post index procedure of fistula creation. Patients will be further followed up to 12 months post index procedure.\n\nMain study question What is the magnitude of benefit of the VasQ device with regard to time to achieving a clinically functional AVF as compared to a comparable contemporary standard of care cohort?",[19],"End Stage Renal Disease",[],"INTERVENTIONAL","PREVENTION",[24],"NA",{"count":26,"type":27},300,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","VasQ","External support implant for the arteriovenous fistula",[34],"End to side fistula supported with VasQ",{"type":36,"name":37,"description":38,"armGroupLabels":39},"PROCEDURE","Arteriovenous fistula creation for dialysis vascular access","End to side fistula creation in the arm for dialysis vascular access",[34,40],"Standard of care end to side fistula",[42],{"measure":43,"description":44,"timeFrame":45},"Fistula functional success","The time, in days, to the first day of a 28-day period in which the study fistula was able to be cannulated with two dialysis needles for at least 75% of dialysis sessions to achieve the prescribed dialysis","6 months",[],"ALL","18 Years","80 Years",{"inclusion":51,"exclusion":52,"raw_text":53},[],[],"Inclusion Criteria:\n\n1. Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical AV fistula for dialysis access (per VasQ IFU and investigator clinical judgment) and consent to take part in the study.\n2. Male and non-pregnant female participants.\n3. Age 18-80 years\n4. Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months.\n\nExclusion Criteria:\n\n1. Index procedure being a revision surgery of an existing fistula.\n2. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the full length of the expected fistula outflow, starting at the planned anastomosis site)\n3. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.\n4. Known central venous stenosis or obstruction on the side of surgery.\n5. Pre-existing stents or stent grafts in the access circuit.\n6. Planned subsequent fistula superficialization procedure.\n7. Known coagulation disorder.\n8. Known allergy to nitinol.\n9. Expected kidney transplant within 12 months of enrollment.\n10. Inability to give consent and\u002For comply with the study follow up schedule.\n11. Insufficient or borderline life expectancy to allow for completion of study procedures and follow-up (12 Months).\n12. Participation in another interventional study that in the judgment of the investigator could confound study results.",[55,56],"ADULT","OLDER_ADULT",[58,76,91,106,124,139,148,166,180],{"facility":59,"status":8,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":73},"Fresenius Vascular Care Long Beach","Long Beach","California","90706","United States",[65,70],{"name":66,"role":67,"phone":68,"email":69},"Deann Helton","CONTACT","562-888-8961","Deann.Helton@azuracare.com",{"name":71,"role":72},"Anthony Becker, MD","PRINCIPAL_INVESTIGATOR",{"lat":74,"lon":75},33.76696,-118.18923,{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":63,"contacts":81,"geoPoint":88},"Sarasota Memorial Hospital","Sarasota","Florida","34239",[82,86],{"name":83,"role":67,"phone":84,"email":85},"Kaitlyn Meek, RN","941-917-7109","kaitlyn-meek@smh.com",{"name":87,"role":72},"Jason Wagner, MD",{"lat":89,"lon":90},27.33643,-82.53065,{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":63,"contacts":96,"geoPoint":103},"Grady Memorial Hospital","Atlanta","Georgia","30303",[97,101],{"name":98,"role":67,"phone":99,"email":100},"Ronnie Adams","+1-404-251-8984","rwadam2@emory.edu",{"name":102,"role":72},"Christopher Ramos, MD",{"lat":104,"lon":105},33.749,-84.38798,{"facility":107,"status":8,"city":108,"state":109,"zip":110,"country":63,"contacts":111,"geoPoint":121},"Brigham and Women's Hospital","Boston","Massachusetts","02115",[112,116,119],{"name":113,"role":67,"phone":114,"email":115},"Danielle Montano","617-525-8555","dmontano2@bwh.harvard.edu",{"name":117,"role":67,"phone":114,"email":118},"Navya Kotturu","nkotturu@bwh.harvard.edu",{"name":120,"role":72},"Mohamad Hussain, MD",{"lat":122,"lon":123},42.35843,-71.05977,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":63,"contacts":129,"geoPoint":136},"Greenwood Leflore Hospital","Greenwood","Mississippi","38930",[130,134],{"name":131,"role":67,"phone":132,"email":133},"Kimberly McMillian","662-453-4641","kmcmillian@glh.org",{"name":135,"role":72},"John F Lucas, MD",{"lat":137,"lon":138},33.51623,-90.17953,{"facility":140,"status":141,"city":142,"state":143,"zip":144,"country":63,"geoPoint":145},"Azura Surgery Center Las Vegas","ACTIVE_NOT_RECRUITING","Las Vegas","Nevada","99128",{"lat":146,"lon":147},36.17497,-115.13722,{"facility":149,"status":8,"city":150,"state":151,"zip":152,"country":63,"contacts":153,"geoPoint":163},"Fresenius Vascular Care Columbia","Columbia","South Carolina","29203",[154,158,161],{"name":155,"role":67,"phone":156,"email":157},"Alicia Phillips-Pough","803-252-3373","alicia.phillips-pough@azuracare.com",{"name":159,"role":67,"phone":156,"email":160},"Tami Hardwick","tami.hardwick@azuracare.com",{"name":162,"role":72},"Dion Franga, MD",{"lat":164,"lon":165},34.00071,-81.03481,{"facility":167,"status":8,"city":168,"state":169,"zip":170,"country":63,"contacts":171,"geoPoint":177},"Houston Methodist Hospital","Houston","Texas","77030",[172,175],{"name":173,"role":67,"phone":99,"email":174},"Abhiraj Sinha","asinha@houstonmethodist.org",{"name":176,"role":72},"Eric Peden, MD",{"lat":178,"lon":179},29.76328,-95.36327,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":63,"contacts":185,"geoPoint":192},"Fairlawn Surgery Center","Roanoke","Virginia","24014",[186,190],{"name":187,"role":67,"phone":188,"email":189},"Aleisha Umber, RN","540-904-6170","AUMBER@FSCMED.COM",{"name":191,"role":72},"Ryan Evans, MD",{"lat":193,"lon":194},37.27097,-79.94143,[196],{"name":197,"role":67,"phone":198,"email":199},"Galit Itzhaki","+972-3-6344246","galit@laminatemedical.com",[201],{"name":202,"affiliation":125,"role":72},"John F Lucas III, MD FACS FSVS",[],[],{"nct_id":4,"conditions":206,"biomarkers":208},[207],"Chronic Kidney Disease, Stage 5",[],{"nct_id":4,"found":210,"summary":211,"prompt_version":221},true,{"design":212,"status":213,"heading":214,"summary":215,"follow_up":216,"word_count":217,"commitments":218,"compensation":219,"drugs_mentioned":220},"This is a multi-center, randomized study with 300 participants. You would be randomly assigned to either receive a fistula with VasQ support or a standard fistula.","completed","VasQ External Support Implant for Dialysis Fistulas","This study is looking at a device called VasQ, which is an external support implant for arteriovenous fistulas (a connection made between an artery and a vein, usually in the arm, to create better access for dialysis). The goal is to see if using VasQ helps these fistulas work better for dialysis compared to the standard way of creating them. You might be able to join if you are between 18 and 80 years old, male or female, and need a new fistula created for dialysis. The study will measure how well the fistula works after 6 months. The current status of the study is unclear, but it plans to enroll 300 patients.","Participants will be followed for up to 12 months after the initial fistula creation procedure.",113,"You would have a procedure to create an arteriovenous fistula. The primary endpoint is measured at 6 months after the procedure.","Not stated in the trial record.",[31],"v2"]