[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555789":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":199,"collaborators":26,"id":201,"slug":202,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":26,"eligibilityCriteria":207,"healthyVolunteers":203,"sex":208,"minAge":209,"maxAge":210,"enrollmentInfo":211,"targetDuration":26,"studyType":214,"phases":215,"briefSummary":217,"conditions":218,"keywords":26,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},{"fullName":5,"class":6},"Laminate Medical Technologies","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"End to side fistula supported with VasQ","EXPERIMENTAL","Patients receiving an end to side arteriovenous fistula, supported by VasQ, 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Itzhaki","CONTACT","+972-3-6344246","galit@laminatemedical.com",[44,65,82,99,119,135,146,166,182],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Fresenius Vascular Care Long Beach","RECRUITING","Long Beach","California","90706","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-118.18923,33.76696,{"lat":56,"lon":55},[59,63],{"name":60,"role":40,"phone":61,"phoneExt":26,"email":62},"Deann Helton","562-888-8961","Deann.Helton@azuracare.com",{"name":64,"role":36,"phone":26,"phoneExt":26,"email":26},"Anthony Becker, MD",{"facility":66,"status":46,"city":67,"state":68,"zip":69,"country":50,"countryCode":51,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Sarasota Memorial Hospital","Sarasota","Florida","34239",{"type":53,"coordinates":71},[72,73],-82.53065,27.33643,{"lat":73,"lon":72},[76,80],{"name":77,"role":40,"phone":78,"phoneExt":26,"email":79},"Kaitlyn Meek, 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Vegas","Nevada","99128",{"type":53,"coordinates":142},[143,144],-115.13722,36.17497,{"lat":144,"lon":143},{"facility":147,"status":46,"city":148,"state":149,"zip":150,"country":50,"countryCode":51,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Fresenius Vascular Care Columbia","Columbia","South Carolina","29203",{"type":53,"coordinates":152},[153,154],-81.03481,34.00071,{"lat":154,"lon":153},[157,161,164],{"name":158,"role":40,"phone":159,"phoneExt":26,"email":160},"Alicia Phillips-Pough","803-252-3373","alicia.phillips-pough@azuracare.com",{"name":162,"role":40,"phone":159,"phoneExt":26,"email":163},"Tami Hardwick","tami.hardwick@azuracare.com",{"name":165,"role":36,"phone":26,"phoneExt":26,"email":26},"Dion Franga, MD",{"facility":167,"status":46,"city":168,"state":169,"zip":170,"country":50,"countryCode":51,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Houston Methodist Hospital","Houston","Texas","77030",{"type":53,"coordinates":172},[173,174],-95.36327,29.76328,{"lat":174,"lon":173},[177,180],{"name":178,"role":40,"phone":95,"phoneExt":26,"email":179},"Abhiraj Sinha","asinha@houstonmethodist.org",{"name":181,"role":36,"phone":26,"phoneExt":26,"email":26},"Eric Peden, MD",{"facility":183,"status":46,"city":184,"state":185,"zip":186,"country":50,"countryCode":51,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Fairlawn Surgery Center","Roanoke","Virginia","24014",{"type":53,"coordinates":188},[189,190],-79.94143,37.27097,{"lat":190,"lon":189},[193,197],{"name":194,"role":40,"phone":195,"phoneExt":26,"email":196},"Aleisha Umber, RN","540-904-6170","AUMBER@FSCMED.COM",{"name":198,"role":36,"phone":26,"phoneExt":26,"email":26},"Ryan Evans, MD",{"type":200,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100555789","post-market-study-for-vasq-an-external-support-implant-for-arteriovenous-fistula-100555789",false,"NCT06516653","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.","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.","ALL","18 Years","80 Years",{"count":212,"type":213},300,"ESTIMATED","INTERVENTIONAL",[216],"NA","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",[219],"End Stage Renal Disease","2026-07-12",{"date":222,"type":223},"2026-07-14","ACTUAL",{"date":225,"type":223},"2025-01-13",{"date":227,"type":213},"2028-05",{"name":5,"class":6},9]