[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100414067":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":388,"collaborators":20,"id":390,"slug":391,"hasResults":392,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":20,"eligibilityCriteria":395,"healthyVolunteers":392,"sex":396,"minAge":397,"maxAge":398,"enrollmentInfo":399,"targetDuration":20,"studyType":402,"phases":403,"briefSummary":405,"conditions":406,"keywords":20,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":420},{"fullName":5,"class":6},"W.L.Gore & Associates","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: InnAVasc AVG treatment","EXPERIMENTAL","Patients will be surgically implanted with an InnAVasc Arteriovenous Graft (IG) in the forearm or upper arm using standard vascular surgical techniques. The graft will be placed in a \"straight\" (soft \"C\") configuration in the upper arm, or looped configuration in the forearm (forearm loop) or upper arm (axillary loop).",[13],"Device: InnAVasc Arteriovenous Graft (IG) surgical implant",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","InnAVasc Arteriovenous Graft (IG) surgical implant","The InnAVasc Arteriovenous Graft (IG) is a hemodialysis vascular access graft, intended for implantation in the lower or upper arm using standard vascular techniques, in patients requiring hemodialysis",[9],null,[22],{"name":23,"affiliation":24,"role":25},"John Ross, MD","MUSC Health Dialysis Access Institute","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Bre Lester","CONTACT","4806986670","blester@wlgore.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Manali Joglekar","9288644063","mjogleka@wlgore.com",[37,58,75,91,108,125,142,159,176,192,205,221,238,254,264,277,294,311,333,355,371],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"AKDHC Medical Research Services, LLC","RECRUITING","Phoenix","Arizona","85012","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-112.07404,33.44838,{"lat":49,"lon":48},[52,56],{"name":53,"role":29,"phone":54,"phoneExt":20,"email":55},"Cynthia Carrizoza","602-200-8288","ccarrizoza@akdhc.com",{"name":57,"role":25,"phone":20,"phoneExt":20,"email":20},"Shouwen Wang, MD",{"facility":59,"status":39,"city":60,"state":61,"zip":62,"country":43,"countryCode":44,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Sarasota Memorial Hospital","Sarasota","Florida","34239",{"type":46,"coordinates":64},[65,66],-82.53065,27.33643,{"lat":66,"lon":65},[69,73],{"name":70,"role":29,"phone":71,"phoneExt":20,"email":72},"Stacy Pratt","941-917-3616","Stacy-Pratt@smh.com",{"name":74,"role":25,"phone":20,"phoneExt":20,"email":20},"Inkyong Parrack, MD",{"facility":76,"status":39,"city":77,"state":61,"zip":78,"country":43,"countryCode":44,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"University of South Florida","Tampa","33606",{"type":46,"coordinates":80},[81,82],-82.45843,27.94752,{"lat":82,"lon":81},[85,89],{"name":86,"role":29,"phone":87,"phoneExt":20,"email":88},"Avennette Pinto","813-505-4787","apinto3@usf.edu",{"name":90,"role":25,"phone":20,"phoneExt":20,"email":20},"Aurelia Thibonnier, MD",{"facility":92,"status":39,"city":93,"state":94,"zip":95,"country":43,"countryCode":44,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Piedmont Augusta","Augusta","Georgia","30901",{"type":46,"coordinates":97},[98,99],-81.97484,33.47097,{"lat":99,"lon":98},[102,106],{"name":103,"role":29,"phone":104,"phoneExt":20,"email":105},"Jennifer Hansen","706-724-2463","Jennifer.Hansen@piedmont.org",{"name":107,"role":25,"phone":20,"phoneExt":20,"email":20},"Houman Tamaddon, MD",{"facility":109,"status":39,"city":110,"state":111,"zip":112,"country":43,"countryCode":44,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"University of Louisville","Louisville","Kentucky","40202",{"type":46,"coordinates":114},[115,116],-85.75941,38.25424,{"lat":116,"lon":115},[119,123],{"name":120,"role":29,"phone":121,"phoneExt":20,"email":122},"Leslie Haysley","502-852-2801","leslie.haysley@louisville.edu",{"name":124,"role":25,"phone":20,"phoneExt":20,"email":20},"Amit Dwivedi, MD",{"facility":126,"status":39,"city":127,"state":128,"zip":129,"country":43,"countryCode":44,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"University of Maryland","Baltimore","Maryland","21201",{"type":46,"coordinates":131},[132,133],-76.61219,39.29038,{"lat":133,"lon":132},[136,140],{"name":137,"role":29,"phone":138,"phoneExt":20,"email":139},"Georges Jreij","410-706-3037","GJreij@som.umaryland.edu",{"name":141,"role":25,"phone":20,"phoneExt":20,"email":20},"Khanjan Nagarsheth, MD",{"facility":143,"status":39,"city":144,"state":145,"zip":146,"country":43,"countryCode":44,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Brigham & Women's Hospital","Boston","Massachusetts","02115",{"type":46,"coordinates":148},[149,150],-71.05977,42.35843,{"lat":150,"lon":149},[153,157],{"name":154,"role":29,"phone":155,"phoneExt":20,"email":156},"Navya Kotturu","617-525-8555","nkotturu@bwh.harvard.edu",{"name":158,"role":25,"phone":20,"phoneExt":20,"email":20},"Nicholas Swerdlow, MD",{"facility":160,"status":39,"city":161,"state":162,"zip":163,"country":43,"countryCode":44,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Rutgers","Newark","New Jersey","07103",{"type":46,"coordinates":165},[166,167],-74.17237,40.73566,{"lat":167,"lon":166},[170,174],{"name":171,"role":29,"phone":172,"phoneExt":20,"email":173},"Yanille Taveras","973-972-6262","taveraya@njms.rutgers.edu",{"name":175,"role":25,"phone":20,"phoneExt":20,"email":20},"Saqib Zia, MD",{"facility":177,"status":39,"city":178,"state":178,"zip":179,"country":43,"countryCode":44,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Mount Sinai Hospital","New York","10029",{"type":46,"coordinates":181},[182,183],-74.00597,40.71427,{"lat":183,"lon":182},[186,190],{"name":187,"role":29,"phone":188,"phoneExt":20,"email":189},"Catherine Marin","212-241-8708","Catherine.Marin@mountsinai.org",{"name":191,"role":25,"phone":20,"phoneExt":20,"email":20},"Ajit Rao, MD",{"facility":193,"status":39,"city":178,"state":178,"zip":194,"country":43,"countryCode":44,"cosmosGeoPoint":195,"geoPoint":197,"contacts":198},"Northwell Health","10075",{"type":46,"coordinates":196},[182,183],{"lat":183,"lon":182},[199,203],{"name":200,"role":29,"phone":201,"phoneExt":20,"email":202},"Nhan Tran","212-434-3420","NNguyenTran@northwell.edu",{"name":204,"role":25,"phone":20,"phoneExt":20,"email":20},"Kenneth Nakazawa, MD",{"facility":206,"status":39,"city":207,"state":178,"zip":208,"country":43,"countryCode":44,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Montefiore Medical Center","The Bronx","10467",{"type":46,"coordinates":210},[211,212],-73.86641,40.84985,{"lat":212,"lon":211},[215,219],{"name":216,"role":29,"phone":217,"phoneExt":20,"email":218},"Agnieszka Siemienik","718-920-4539","asiemien@montefiore.org",{"name":220,"role":25,"phone":20,"phoneExt":20,"email":20},"Saadat Shariff, MD",{"facility":222,"status":39,"city":223,"state":224,"zip":225,"country":43,"countryCode":44,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Surgical Specialists of Charlotte","Charlotte","North Carolina","28204",{"type":46,"coordinates":227},[228,229],-80.84313,35.22709,{"lat":229,"lon":228},[232,236],{"name":233,"role":29,"phone":234,"phoneExt":20,"email":235},"Decca Taylor","704-945-3560","dtaylor@ssclt.com",{"name":237,"role":25,"phone":20,"phoneExt":20,"email":20},"Jason Burgess, MD",{"facility":239,"status":39,"city":240,"state":224,"zip":241,"country":43,"countryCode":44,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Duke University Medical Center","Durham","27705",{"type":46,"coordinates":243},[244,245],-78.89862,35.99403,{"lat":245,"lon":244},[248,252],{"name":249,"role":29,"phone":250,"phoneExt":20,"email":251},"Ellen Burkett","919-681-1878","ellen.jones@duke.edu",{"name":253,"role":25,"phone":20,"phoneExt":20,"email":20},"Tristen Chun, MD",{"facility":255,"status":256,"city":257,"state":224,"zip":258,"country":43,"countryCode":44,"cosmosGeoPoint":259,"geoPoint":263,"contacts":20},"NC Heart and Vascular Research, LLC","ACTIVE_NOT_RECRUITING","Raleigh","27607",{"type":46,"coordinates":260},[261,262],-78.63861,35.7721,{"lat":262,"lon":261},{"facility":265,"status":39,"city":257,"state":224,"zip":266,"country":43,"countryCode":44,"cosmosGeoPoint":267,"geoPoint":269,"contacts":270},"WakeMed","27610",{"type":46,"coordinates":268},[261,262],{"lat":262,"lon":261},[271,275],{"name":272,"role":29,"phone":273,"phoneExt":20,"email":274},"Rhonda Norton","919-350-5252","RNORTON@wakemed.org",{"name":276,"role":25,"phone":20,"phoneExt":20,"email":20},"Kirk Charles, MD",{"facility":278,"status":39,"city":279,"state":280,"zip":281,"country":43,"countryCode":44,"cosmosGeoPoint":282,"geoPoint":286,"contacts":287},"Guthrie Clinic","Sayre","Pennsylvania","18840",{"type":46,"coordinates":283},[284,285],-76.5155,41.97896,{"lat":285,"lon":284},[288,292],{"name":289,"role":29,"phone":290,"phoneExt":20,"email":291},"Laura Warner","570-887-6070","Laura.Warner@guthrie.org",{"name":293,"role":25,"phone":20,"phoneExt":20,"email":20},"Amber Hussain, MD",{"facility":295,"status":39,"city":296,"state":297,"zip":298,"country":43,"countryCode":44,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"Prisma Health- Upstate","Greenville","South Carolina","29615",{"type":46,"coordinates":300},[301,302],-82.39401,34.85262,{"lat":302,"lon":301},[305,309],{"name":306,"role":29,"phone":307,"phoneExt":20,"email":308},"Maggie Salle, RN- Research Coordinator","864-607-3405","margaret.salle@prismahealth.org",{"name":310,"role":25,"phone":20,"phoneExt":20,"email":20},"Sagar Gandhi, MD",{"facility":312,"status":39,"city":313,"state":297,"zip":314,"country":43,"countryCode":44,"cosmosGeoPoint":315,"geoPoint":319,"contacts":320},"Medical University of South Carolina","Orangeburg","29118",{"type":46,"coordinates":316},[317,318],-80.85565,33.49182,{"lat":318,"lon":317},[321,325,329,331],{"name":322,"role":29,"phone":323,"phoneExt":20,"email":324},"Virginia Anderson, RN","803-395-3878","vdanderson@regmed.com",{"name":326,"role":29,"phone":327,"phoneExt":20,"email":328},"Amy Lawson","803-395-2897","aclawson@regmed.com",{"name":330,"role":25,"phone":20,"phoneExt":20,"email":20},"Mark London, MD",{"name":23,"role":332,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"facility":334,"status":335,"city":336,"state":337,"zip":338,"country":43,"countryCode":44,"cosmosGeoPoint":339,"geoPoint":343,"contacts":344},"Baylor Heart and Vascular","NOT_YET_RECRUITING","Dallas","Texas","75246",{"type":46,"coordinates":340},[341,342],-96.80667,32.78306,{"lat":342,"lon":341},[345,349,353],{"name":346,"role":29,"phone":347,"phoneExt":20,"email":348},"Katalin Martits-Chalangari","214-820-1722","katalin.martitschalangari@bswhealth.org",{"name":350,"role":29,"phone":351,"phoneExt":20,"email":352},"Mariana Hurutado","214-818-6832","Mariana.Hurutado@BSWHealth.org",{"name":354,"role":25,"phone":20,"phoneExt":20,"email":20},"Stephen Hohmann, MD",{"facility":356,"status":39,"city":357,"state":337,"zip":358,"country":43,"countryCode":44,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"Houston Methodist Hopsital","Houston","77030",{"type":46,"coordinates":360},[361,362],-95.36327,29.76328,{"lat":362,"lon":361},[365,369],{"name":366,"role":29,"phone":367,"phoneExt":20,"email":368},"Caroline Antunes","346-238-4552","cantunes@houstonmethodist.org",{"name":370,"role":25,"phone":20,"phoneExt":20,"email":20},"Eric Peden, MD",{"facility":372,"status":39,"city":373,"state":374,"zip":375,"country":43,"countryCode":44,"cosmosGeoPoint":376,"geoPoint":380,"contacts":381},"University of Washington","Seattle","Washington","98195",{"type":46,"coordinates":377},[378,379],-122.33207,47.60621,{"lat":379,"lon":378},[382,386],{"name":383,"role":29,"phone":384,"phoneExt":20,"email":385},"Alex Ruiz","206-221-3883","aruiz06@uw.edu",{"name":387,"role":25,"phone":20,"phoneExt":20,"email":20},"Elina Quiroga, MD",{"type":389,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100414067","a-study-to-evaluate-the-safety-and-effectiveness-of-the-innavasc-arteriovenous-graft-for-hemodialysis-access-in-patients-with-end-stage-renal-disease-100414067",false,"NCT04671771","A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease","Inclusion Criteria:\n\nPre-Operative Inclusion Criteria:\n\nPatients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study:\n\n1. Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy;\n2. Age 18 to 90 years old, inclusive;\n3. Suitable anatomy for implantation of upper arm \"straight\" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow);\n4. Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition);\n5. Able and willing to give informed consent;\n6. Anticipated life expectancy of at least 1 year.\n\nIntra-Operative Inclusion Criteria:\n\nBoth vessels have been exposed and are deemed appropriate for implantation (i.e., based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow, is without significant calcification, and is safely clampable; and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction).\n\nPre-Operative Exclusion Criteria:\n\nPatients will be excluded from the study at screening if they exhibit any of the following exclusion criteria:\n\n1. History or evidence of severe cardiac disease (i.e., debilitating heart failure, or high risk of MI) in the opinion of the investigator which may preclude participation in and completion of the study;\n2. Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations);\n3. For upper arm straight configuration, an antecubital fossa crease to axillary crease distance \\\u003C 18 cm;\n4. History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access);\n5. Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;\n6. Baseline hypotension or history of frequent hypotensive episodes during dialysis that, in the opinion of the investigator, puts the patient at increased risk of graft thrombosis;\n7. Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness);\n8. Baseline hemoglobin \\\u003C7 g\u002FdL;\n9. Baseline platelet count \\\u003C50,000 or \\>500,000 cells\u002Fmm3;\n10. Documented history of stroke within 6 months prior to enrollment;\n11. Treatment with any investigational drug or device within 30 days prior to enrollment;\n12. Female patients who are pregnant, intending to become pregnant, nursing or intending to breastfeed during the study (pregnancy test may only be omitted, if patient is post-menopausal or has a documented history of hysterectomy or permanent sterilization);\n13. History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin;\n14. Immunodeficiency including documented history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or patients receiving immunosuppressive therapy for treatment of an acute inflammatory event or autoimmune flare. Chronic immunosuppressive therapy is acceptable;\n15. Documented or suspected hypercoagulable condition;\n16. Bleeding diathesis, other than that associated with ESRD;\n17. Documented history of heparin-induced thrombocytopenia (HIT);\n18. Active local or systemic infection as documented from the medical history or bloodwork\u002Fblood culture data. If the infection resolves, the subject must be at least one-week post resolution of that infection before implantation;\n19. Scheduled renal transplant within 6 months;\n20. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the IG;\n21. Patient is unable or unwilling to complete all required follow-up assessments and questionnaires.","ALL","18 Years","90 Years",{"count":400,"type":401},133,"ESTIMATED","INTERVENTIONAL",[404],"NA","The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are:\n\nPrimary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months.\n\nPrimary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months.\n\nParticipants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.",[407,408,409,410],"End Stage Renal Disease (ESRD)","Kidney Failure","Chronic Renal Disease","Hemodialysis","2025-12-18",{"date":413,"type":414},"2025-12-22","ACTUAL",{"date":416,"type":414},"2020-12-03",{"date":418,"type":401},"2029-07-01",{"name":5,"class":6},21]