{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,8]],"date-time":"2026-11-08T03:11:54Z","timestamp":1794107514003,"version":"4.8.0"},"reference-count":52,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T00:00:00Z","timestamp":1763683200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Xeltis BV","award":["Xeltis BV is the sponsor of the aXess FIH study"],"award-info":[{"award-number":["Xeltis BV is the sponsor of the aXess FIH study"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Vasc Access"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Xeltis\u2019 aXess hemodialysis (HD) conduit is a novel arteriovenous graft (AVG) made of bioabsorbable polymer, replaced by body-own tissue, through endogenous tissue restoration (ETR).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>An ongoing prospective, single-arm, multi-center first-in-human (FIH) study evaluates safety and performance in hemodialysis patients unsuitable for arteriovenous fistula (AVF) creation. Primary and secondary 12-months outcomes are reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The aXess conduit was implanted in 20 patients. Freedom from device-related serious adverse events (SAEs) was 100% at 6\u2009months and 95% at 12\u2009months, with no access-related infections. Two unrelated deaths occurred. Primary and secondary patency rates were 80% and 100% at 6\u2009months, 39% and 100% at 12\u2009months. Access-related interventions occurred in 61% of patients, mainly for thrombosis and stenosis (71%), and pseudoaneurysms (29%). Histology showed remodeling at 6\u2009months; the polymer was almost resorbed at 15\u2009months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>This bioengineered conduit shows favorable safety and performance for 1\u2009year. However, long-term validation in a pivotal trial is warranted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration:<\/jats:title>\n                    <jats:p>\n                      First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess-FIH) (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ); Unique identifier: NCT04898153.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/11297298251395823","type":"journal-article","created":{"date-parts":[[2025,11,22]],"date-time":"2025-11-22T04:50:17Z","timestamp":1763787017000},"page":"1234-1244","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Endogenous tissue restoration in a hemodialysis conduit: Performance and safety after 1-year of follow-up"],"prefix":"10.1177","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7300-8260","authenticated-orcid":false,"given":"Matteo","family":"Tozzi","sequence":"first","affiliation":[{"name":"Vascular Unit, Department of Medicine and Surgery, Insubria University and Research Center, Varese, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"De Letter","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, AZ-Sint Jan Brugge, Bruges, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dainis","family":"Krievins","sequence":"additional","affiliation":[{"name":"Pauls Stradins Clinical University Hospital, Riga, Latvia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janis","family":"Jushinskis","sequence":"additional","affiliation":[{"name":"Pauls Stradins Clinical University Hospital, Riga, Latvia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annick","family":"D\u2019Haeninck","sequence":"additional","affiliation":[{"name":"Renal Division, Ghent University Hospital, Ghent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kestutis","family":"Rucinskas","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Angiology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marius","family":"Miglinas","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Angiology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomas","family":"Baltrunas","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Angiology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sigi","family":"Nauwelaers","sequence":"additional","affiliation":[{"name":"Department of Thoracic and Vascular Surgery, Ziekenhuis Oost-Limburg, Genk, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frederick J.","family":"Schoen","sequence":"additional","affiliation":[{"name":"Department of Pathology, Brigham and Women\u2019s Hospital, Harvard Medical School, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renu","family":"Virmani","sequence":"additional","affiliation":[{"name":"CVPath Institute, Gaithersburg, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9596-8529","authenticated-orcid":false,"given":"An S","family":"De Vriese","sequence":"additional","affiliation":[{"name":"Department of Nephrology and Infectious Diseases, AZ-Sint Jan, Brugge, Bruges, 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